FDA Consumer Magazine VOL. 31 NO. 5 JULY-AUGUST 1997 ------------------------------------------------------------------------ Features Dieter's Brews Make Tea Time a Dangerous Affair The active ingredients in dieter's teas--herbal laxatives--won't help you lose weight, and may cause cramps, diarrhea and even more severe problems. When Summertime Gets Too Hot to Handle Hot fun in the summertime can sometimes have serious, even lethal, consequences. But a few simple precautions can prevent heat-related illness. A Dose of Clear Directions for Rx Drug Users The simple--and uninformative--phrase "use as directed" will give way to detailed information in nonmedical language on all prescription drugs under a new voluntary plan FDA will monitor. Bulking Up Fiber's Healthful Reputation "Beans, beans, the musical fruit. The more you eat, the more you toot." Fiber--with all its many contributions to health--deserves more respect than that. Incontinence Can Be Controlled Urinary incontinence can devastate a person's quality of life. But myriad treatment options, including two new devices FDA approved in 1996, can bring the quality back. On the Teen Scene: Overcoming the Deficit of Attention Disorder Teens with attention-deficit/hyperactivity disorder need more than adults yelling at them to pay attention. Drugs and coping skills can help them succeed in school and life. ------------------------------------------------------------------------ Departments Updates The latest information on FDA-related issues, gathered from FDA Press Releases, Talk Papers, and other sources. Notebook A potpourri of items of interest gathered from the Federal Register and other sources. Investigators' Reports Selected cases illustrating regulatory and administrative actions--such as inspections, recalls, seizures, and court proceedings--by FDA's regional and district offices across the country Summaries of Court Actions Cases involving seizure, criminal and injunction proceedings. ------------------------------------------------------------------------ Dieter's Brews Make Tea Time A Dangerous Affair by Paula Kurtzweil A cup of hot herbal tea may feel soothing to the soul, but instead of soothing the body, some herbal teas can make you sick. This is especially true with so-called dieter's teas, herbal teas containing senna, aloe, buckthorn, and other plant-derived laxatives that, when consumed in excessive amounts, can cause diarrhea, vomiting, nausea, stomach cramps, chronic constipation, fainting, and perhaps death. In recent years, FDA has received "adverse event" reports, including the deaths of four young women, in which dieter's teas may have been a contributing factor. As a result, FDA is advising consumers to follow package directions carefully when using dieter's teas and other dietary supplements containing senna, aloe, and other stimulant laxatives. Consumers should seek medical attention for persistent diarrhea, abdominal cramps, and other bowel problems to prevent more serious complications. The agency may consider requiring manufacturers to place a warning about the products' potential side effects on the products' labels. Some manufacturers already are doing so voluntarily. These products--bought in health food stores and through mail-order catalogs, for example--often are used for weight loss based on some consumers' belief that increased bowel movements will prevent absorption of calories, thus preventing weight gain. However, a special committee of FDA's Food Advisory Committee concluded in 1995 that studies show that laxative-induced diarrhea does not significantly reduce absorption of calories. This is because the laxatives do not work on the small intestine, where calories are absorbed, but rather on the colon, the lower end of the bowel. Juice drinks and tablets also may contain stimulant laxatives. FDA usually regulates these products as foods under the Federal Food, Drug, and Cosmetic Act. If the products are represented as dietary supplements, they are regulated under the Dietary Supplement Health and Education Act of 1994. Stimulant Laxatives The stimulant laxative teas and dietary supplements FDA is most concerned about contain one or more of the substances senna, aloe, rhubarb root, buckthorn, cascara, and castor oil. These plant-derived products have been used since ancient times for their ability to promote bowel movements and relieve constipation. Several, such as cascara, senna and castor oil, also are available as over-the-counter drug laxatives and are regulated as drugs. Some of these substances also are used in much smaller quantities as natural flavorings in other foods. As such, they are regulated by FDA as food additives or "generally recognized as safe" substances. FDA has not received any information suggesting that these substances pose a hazard when used in the amounts normally needed to provide flavoring. Except when used solely as flavorings, the names of these plant substances appear in the ingredient list on the label of these products. Dieter's teas and similar products often list the substances at or near the top because they often are the main ingredients. FDA proposed in December 1995 to require manufacturers to declare dietary ingredients, including proprietary blends, in descending order of predominance by weight on product labels. In the proposed rule, the substance would have to be given by its common or usual name: for example, Tinnevelly senna followed by its Latin name, Cassia angustifolia. Most consumers who use dieter's teas and similar products know that the products have laxative properties, according to health professionals familiar with the products, even though the product labeling does not specifically state the term "laxative." Instead, the labeling may promote the product as a natural bowel cleanser. Sometimes it may not reflect the laxative qualities at all. The product labels may not directly state that the products are for weight loss, although some allude to it. For instance, some products use the terms "dieter's," "diet," "trim," or "slim" in their names. Others may carry information on weight-loss practices, mentioning consumption of the product along with the weight-loss practices. Some of the teas are labeled as "low-calorie." Unless sweetened, they provide essentially no nutrients and no calories. According to Ara DerMarderosian, Ph.D., professor of pharmacognosy (study of medicinal products in their crude, or unprepared, form) and medicinal chemistry at the Philadelphia College of Pharmacy and Science, users favor the products because they believe that the products may cost less and taste better than over-the-counter laxatives and because they are easy to buy. In addition, he said, people with eating disorders, such as bulimia and anorexia nervosa, may like the products because they act quickly and produce loose, watery stools. Unfortunately, this practice is not only useless for losing weight but can be dangerous for people on severely restricted diets. Writing in the January 1996 American Druggist, DerMarderosian and his colleague Sharon Brudnicki, a registered pharmacist also with the Philadelphia College of Pharmacy and Science, noted that some users like dieter's tea and other stimulant laxatives for their purported "body cleansing" ability. DerMarderosian was a member of the FDA Food Advisory Committee's 1995 special task group on stimulant laxative substances in food. Adverse Effects Reports filed with FDA indicate that users tend to experience adverse effects when they misuse the products by, for example, steeping the tea longer than product labeling recommends or drinking more than the recommended amount. The reports indicate three types of adverse events: * Short-term: stomach cramps, nausea, vomiting, and diarrhea lasting several days. These symptoms are likely to occur in first-time users who drink more than the recommended amount. * Chronic: chronic diarrhea, pain and constipation due to laxative dependency, which causes a sluggish bowel. In one report to FDA, a person who reported using herbal products with stimulant laxatives for decades suffered severe pain and constipation from loss of colon function and required surgery to remove the colon. People who develop chronic problems usually have used these types of products for years. * Severe: fainting, dehydration and electrolyte disorders (for example, low blood potassium, a condition that can cause paralysis, irregular heartbeat, and possibly death). People who develop severe problems tend to be those who are nutritionally compromised, partly as a result of drastic reductions in food intake--for example, rigorous weight-loss dieters and people with the eating disorders anorexia nervosa and bulimia. Four deaths reported to FDA involved women with a history of such medical problems. According to information presented at a 1995 meeting of FDA's Food Advisory Committee, these herbal stimulant laxatives may have been a contributing factor in their deaths. Label Warning At the 1995 meeting, the advisory committee's task group agreed that dietary supplements containing stimulant laxatives can have adverse effects and that a label statement would be helpful in warning consumers about the risks and reducing the incidence of these adverse effects. The group proposed this label warning: "NOTICE (or WARNING): Contains herbs (insert name of herbs) that can act as stimulant laxatives. Prolonged steeping time can increase the risk of adverse laxative effects, including: nausea, vomiting, abdominal cramps, and diarrhea. Chronic use of laxatives can impair colon function. Use of laxatives may be hazardous in the presence of abdominal pain, nausea, vomiting, or rectal bleeding. Laxative-induced diarrhea does not significantly reduce absorption of food calories. Acute or chronic diarrhea may result in serious injury or death." The full advisory committee concurred with the recommendations. California has taken steps to require a similar warning label statement on all food products containing stimulant laxatives sold in that state. Some manufacturers have begun to carry the state's drafted warning statement on their food products. FDA will monitor products sold nationally to be sure that their labels carry information similar to that required in California. Consumer Action The California warning advises all users of these types of dietary supplements to: * Read and follow package directions carefully. * Stop using the product if diarrhea, loose stools, or stomach pain develop. * See a doctor if frequent diarrhea develops. * See a doctor before using the product if the user is pregnant, nursing, taking medication, or has a medical condition. Consumers should report adverse effects associated with use of laxative teas or supplements to FDA by calling or writing to their local FDA office, listed in the blue pages of the telephone book under U.S. Government, Department of Health and Human Services, Food and Drug Administration. They also may write to FDA at 5600 Fishers Lane, HFC-160, Rockville, MD 20857. The report should include: * name, address and telephone number of the person who became ill * name and address of the doctor or hospital providing medical treatment * description of the problem * name of the product and store where it was bought. Consumers also should report the problem to the manufacturer or distributor listed on the product's label and to the store where the product was bought. FDA encourages health professionals to report serious adverse reactions, too, if the reaction appears related to the patient's use of dieter's teas or similar products. Health professionals can call FDA's MedWatch adverse event and product problem hot line at (1-800) FDA-1088. Paula Kurtzweil is a member of FDA's public affairs staff. FDA Consumer magazine (July-August 1997) ------------------------------------------------------------------------ When Summertime Gets Too Hot to Handle by Rebecca D. Williams On the morning of July 7, 1996, a 74-year-old woman was found dead under her kitchen table in Fort Worth, Texas. A victim of heatstroke, she was using only a single fan to cool the house. She hadn't turned on her air conditioner to save money on the electric bill, her sister later told police. The temperature inside the house was over 38 degrees Celsius (100 degrees Fahrenheit). Last summer, seven people died of heatstroke in Texas. In the big heat wave of 1980, 78 people died. "Heat has always been a health problem for Texas," says David Vaughan of the Texas Department of Health in Austin. "We get some real scorchers." Texas and other southern states have the highest rates of heat illnesses and deaths, but such deaths can occur nearly anywhere. Typically, about 240 people in the United States die from heat illnesses each year, according to the national Centers for Disease Control and Prevention. During heat waves, that number has risen to as high as 1,700. Heatstroke is one of several maladies known as heat illness. The others are heat syncope, heat cramps, and heat exhaustion. All of them occur when the body's ability to regulate its own heat is impaired, either because of exercise or exposure to hot temperatures. Certain health conditions and medications also increase the likelihood of heatstroke. But, says Elizabeth Koller, M.D., an outdoor enthusiast and endocrinologist in FDA's Center for Drug Evaluation and Research, "Heatstroke is entirely preventable." Yet when it strikes, it becomes life-threatening. "If someone is overheating, you have only minutes to do something about it," she says. "You have to cool them down as quickly as you can. Once their brain is overheated, that's it." Body Heat Control Our bodies are like car engines. They chug along, producing heat in the process. The skin and blood are like the cooling system of the car. Blood warms up as it passes through muscles and tissue. It carries extra heat to the surface of the skin, where the surrounding air cools it. Unlike an engine, however, our bodies have the benefit of sweat, a very efficient cooling liquid. For example, a pearl-sized bead of sweat can cool nearly one liter (about 1 quart) of blood 1.8 C (1 F), using 580 calories in the process. But in hot, humid weather, sweat doesn't work as well. The surrounding air is already warm and heavy with humidity, and it cannot absorb extra heat and sweat. So the body begins to warm up, and the heart begins pumping more blood to the skin to release the extra heat. Even if you sit still, your heart will beat faster. Have you ever felt tired after a day spent lounging on the beach? That fatigue comes from your heart working overtime to cool your body. If you sweat a great deal of water and lose enough minerals, you could develop one or more heat illnesses. The mildest, most common heat syndrome is called heat cramps. It usually occurs in people who have been exercising in hot, humid weather. As the victim sweats, minerals are excreted from the body. This mineral depletion causes muscles to contract in slow, painful spasms lasting one to three minutes, usually after the person has stopped exercising. A person with heat cramps needs fluids, extra salts, a cooler environment, and rest. A second syndrome is heat exhaustion (it has also been termed heat syncope or heat collapse). This syndrome occurs when a person has lost either too much water or too much salt through sweating. Depending on the cause, the victim may or may not have an elevated temperature. In either case, he or she will feel thirsty, nauseated, headachy, weak, and confused. The victim may soon pass out, pulse racing. A heat exhaustion victim needs to lie flat in a cool place, with water and electrolyte fluids to drink as soon as he or she regains consciousness. Intravenous fluids might be necessary. Danger: Heatstroke The most dangerous heat illness is heatstroke. Heatstroke is a life-threatening medical emergency. The victim may develop headache, slurred speech, dizziness, faintness, hallucinations, seizures, and may even become comatose. Body temperature soars to 40 C (104 F) or more. The person becomes so dehydrated that the skin no longer sweats and is hot and dry to the touch. There are two types of heatstroke: classic and exertional. Classic heatstroke occurs in individuals who don't sweat normally, either because of a disease or certain medications. Without normal sweating, it's difficult for a person to handle hot, humid weather. The typical victim of classic heatstroke is an older adult who lives without air conditioning and has underlying health problems, such as heart disease or diabetes. Classic heatstroke can take two or three days to develop, but it is very dangerous. Studies have shown that even a few hours of air conditioning each day can prevent the condition. Exertional heatstroke, on the other hand, happens quickly--often after only a few hours of exercise. The skin is able to sweat, but the body still overheats because of the combination of hot weather, extra activity, and dehydration. Exertional heatstroke victims are usually young, otherwise healthy people, such as runners and football players. Exertional heatstroke has long been studied by the military. The U.S. Marines at Parris Island, S.C., for example, have studied heat illness among new recruits. They found that even though soldiers train in the early morning and are required to drink lots of water, as many as 2 percent of them will suffer heat illnesses during the summer months, and about 1 percent in the winter. The risk of exertional heat injuries depends on the heat and humidity, the soldier's fitness level, and whether or not the person is used to hot weather. The treatment for both classic and exertional heatstroke is the same: Cool the victim as quickly as possible with whatever means available--for example, wet sheets, a fan, or ice under the armpits. (While the military routinely uses ice to cool heatstroke victims, some studies have shown this can also cause frostbite.) Give the victim liquids, if possible, and get medical attention immediately. Early treatment increases a heatstroke victim's chance of survival. Who's at Risk Certain health conditions increase a person's risk of heat illness. Obesity, sweat gland diseases, diabetes, dehydration (a shortage of body fluids), malnutrition, low blood pressure, and heart disease all make it difficult for the body to regulate heat. In many instances, patients have more than one of these conditions. Older adults, especially, are more likely to have multiple health problems. Older adults also are more likely to take medicines that impair the body's ability to regulate heat. Some drugs slow sweat production. These include anticholinergics (used to treat Parkinson's disease), antihistamines (for allergies), phenothiazines (tranquilizers), tricyclic antidepressants, and diuretics (for high blood pressure). Some restrict blood flow to the skin, impairing the body's ability to release heat. These include cardiovascular drugs, such as vasoconstrictors and beta blockers. If you or someone you know lives without air conditioning and takes any of these medicines, ask a doctor or pharmacist about the medicine's possible ill effects in hot weather. Also at risk are people who use illicit drugs, such as LSD, cocaine and amphetamines. These drugs increase muscle activity and body heat. Excessive alcohol use greatly increases a person's risk for heat illness, too. Alcohol causes the body to excrete water, leading to dehydration. People who are unable to move about easily--for example, disabled, homeless, and very poor people--are at a higher risk for heat illness because they often cannot afford air conditioning or get to a place that has it. Also, children under 2 can be prone to heat illness because their small bodies cannot regulate body heat as efficiently as older children or adults can. They also may not be able to escape hot places; every summer there are tragic reports of young children who die of heatstroke because they are left in locked automobiles even for short periods. A victim of heat exhaustion or heatstroke needs immediate medical attention. The important thing is speed: The faster the victim is cooled and rehydrated, the better his or her chance for survival. Says FDA's Koller, "If people have heatstroke, they really need to get care quickly. This is truly a medical emergency." Rebecca D. Williams is a writer in Oak Ridge, Tenn. ------------------------------------------------------------------------ Preventing Heatstroke "... At harvest time, the boy went out one morning to join his father, who was in the field with the harvest workers. Suddenly he cried out to his father, 'My head hurts! My head hurts!' ... The servant carried the boy back to his mother, who held him in her lap until ... he died." --2 Kings 4:18-20 In what may be one of the oldest accounts of heatstroke, the Bible tells of this ailment's deadly end. Luckily for the boy, the prophet Elisha was near, and the scripture recounts a miraculous rising from the dead. It's still possible to survive heatstroke, but it's far easier to prevent it. Here's how: * Take it easy, especially if you are over 65, on any heart or blood medication, or are overweight. Don't make any changes with your medications without your doctor's OK. Don't exert yourself in the summer heat. Exercise in an air-conditioned building if possible. * If you exercise outdoors in the summer, do so in the early morning or late evening hours when it's cooler. * Get used to hot weather slowly. When exercising or doing some other activity outdoors in hot weather, start slowly and gradually increase the time each day. Studies have shown that getting used to the hot weather gradually increases the body's ability to sweat freely without losing salts. It takes about two to four weeks of exercising in the heat before you'll become acclimatized. * Drink lots of water in the summer. If you're exercising, that means about 1 liter (about 1 quart) every hour. If you're just puttering in the garden, take a large jug of water with you, and sip it continuously. Don't rely on thirst to tell you when to drink; people often don't feel thirsty until they're a little dehydrated. Sports drinks and special rehydration fluids are OK, but studies have shown that water alone, combined with a normal amount of dietary salt prevents dehydration in most people. Do not take salt tablets, unless advised to by a doctor, because the excess amount of sodium in them can increase the risk of kidney damage. * Wear a hat with a broad brim to protect you from the sun and loose clothing to allow sweat to evaporate. * Wear sunscreen. A sunburn will inhibit your skin's ability to sweat. * Stay in an air-conditioned environment on hot days. If that's not possible, take cool baths, spray yourself with water frequently, and sit in front of a fan. If you feel faint, call for emergency medical attention. --R.D.W. ------------------------------------------------------------------------ Heatstroke Risk In hot weather, these factors can put you at risk for heatstroke: * exercise, especially if you're not physically fit * heavy clothing * living on upper floors of a building without air-conditioning * not drinking enough fluids, leading to dehydration (shortage of body fluids) * drinking too much alcohol * obesity * tiredness * older age (65 and over) * high outdoor humidity * lack of wind * medical conditions--including alcoholism, neurologic lesions, cardiovascular disease, skin or sweat gland diseases that inhibit the skin's ability to sweat, diabetes, chronic obstructive pulmonary disease, hyperthyroidism, hypokalemia (potassium deficiency), infections that cause fever, and taking certain medications for psychiatric illnesses. --R.D.W. FDA Consumer magazine (July-August 1997) ------------------------------------------------------------------------ A Dose of Clear Directions for Rx Drug Users by Tamar Nordenberg More than four centuries ago, doctors were considered omnipotent, and the ethical statutes of England's Royal College of Physicians instructed: "Let no physician teach the people about medicines, or even tell them the names of the medicines, particularly the more potent ones ... for the people may be harmed by their improper use." While doctors today are more forthcoming, many patients still have a hard time getting important information about the drugs their doctors prescribe. In a time when Corn Flakes, over-the-counter Tylenol, and even Alpo dog food come with easy-to-understand information about proper use, many prescription drugs still come with only a "Use as Directed" sticker for patients. The rest of the labeling is for the medical professional, in language that may be difficult for lay people to understand. This lack of information for patients may be one reason for the recent finding, published in 1992 in the Journal of Clinical Pharmacy and Therapeutics, that about half of prescription drugs don't work as intended because they are improperly used. Noncompliance can have tragic consequences. Missed doses of heart medications, for example, may lead to cardiac arrest. And missed doses of anti-glaucoma medicines can lead to eye nerve damage and blindness. To help avoid medication problems, a new "Action Plan for the Provision of Useful Medicine Information" was unveiled in January 1997 to provide more and better information to patients. Simple, Relevant Information Under the action plan, health professionals will voluntarily provide prescription drug information to patients in the form of leaflets written in simple language. Useful prescription drug information must reach at least 75 percent of patients by the year 2000, in keeping with the Department of Health and Human Services goal under its Healthy People 2000 program. By 2006, the information must reach at least 95 percent of patients. If these goals aren't met, FDA may require the information by regulation. The plan was developed with the input of health professionals and consumer, government and industry representatives. "Working together and using today's computer technology," said Secretary of Health and Human Services Donna Shalala when she approved the plan, "we can make prescription information more widely available, more understandable, and more relevant for each individual patient." The action plan calls for the written information to include the condition(s) for which the drug is used, directions for taking the drug correctly, and possible side effects. Doctors or pharmacists can add information about an "off-label" use--a use that is not approved by FDA--if it is written based on an individual patient's needs. Health professionals are responsible for getting the information to patients. FDA is available for technical assistance and will work to educate the public about the plan, according to Thomas McGinnis, a pharmacist and FDA's associate director of pharmacy affairs. FDA will survey consumers nationwide in the year 2000 and again in 2006 to determine if the goals have been met. The agency will evaluate samples of the patient labeling to make sure it provides the required information in simple language. (See "Is the Labeling Useful?") FDA has tried before to provide prescription medicine information to consumers. A rule the agency proposed in 1979 would have required manufacturers to include leaflets known as patient package inserts, or PPIs, with 10 prescription drugs or drug classes. The rule was withdrawn in 1982 to allow private organizations time to provide the information voluntarily. In the next decade, FDA research showed minimal progress in getting good-quality medication information to patients. So, in 1995, FDA proposed a rule, commonly called MedGuide, that set forth goals for the distribution of useful prescription drug information to consumers and would have required manufacturers to include drug information for the patient when a product posed a serious health risk. In August 1996, Congress passed legislation that put the MedGuide proposal on hold to provide another opportunity for private achievement of the MedGuide goals. The action plan is the private sector's framework for achieving those goals. Labeling Lacking Currently, manufacturers provide patient information for about 40 prescription drugs or drug classes. FDA requires patient information for some drugs, including oral contraceptives and isoproterenol inhalation products used by asthmatics. Manufacturers voluntarily provide FDA-reviewed patient labeling with some other products, such as Accutane (isotretinoin) for acne and Halcion (triazolam) for insomnia. A 1997 FDA survey found that 67 percent of consumers were getting some written information with their prescription drugs, up from 54 percent in 1994. But the surveys don't take into consideration the quality of the information. "The materials being given to consumers are very variable," McGinnis says. "Some are very poor, some are very good, and some are in-between. Most of the information out there now is going to have to be beefed up to meet the action plan criteria." By increasing patients' knowledge about their drug therapies, the action plan aims to help patients take their drugs correctly. Improper use of prescription drugs leads to unnecessary illnesses, emergency room visits, hospital admissions, and deaths. FDA estimates extra health-care costs from preventable drug-related illnesses to be at least $20 billion a year. (See "Medication Mishaps.") In addition to instructions for proper use, the information sheets will address a drug's risks and side effects, according to McGinnis. By telling patients what to look for and what to do if they see warning signs, the information may help patients recognize side effects earlier, before serious damage is done. "These drugs are risky--they wouldn't be prescription drugs if they weren't--and patients have a right to know what the risks are," McGinnis says. Some groups representing the pharmaceutical industry and health professionals have expressed concern to FDA that informing patients of risks and side effects may hurt compliance by scaring consumers out of taking the drug as prescribed. To this, McGinnis replies, "We've heard that argument, but we've never seen it supported scientifically." Empowering the Patient Written information sheets cannot replace the advice of a health professional. But there are some barriers to communication between patients and health professionals, according to David Schulke, director of policy and regulatory affairs at the American Pharmaceutical Association. "There are financial pressures that cause doctors and pharmacists to talk to more patients in less time, giving less time to each patient." Because of the competing demands on health professionals' time, written information is especially important. "The piece of paper becomes a back-up, a safety net that patients can keep with them and refer to for information," says consumer advocate Arthur Levin, director of the Center for Medical Consumers. Patients sometimes need to take on a very active role in their own health care, according to McGinnis. "FDA is hoping the additional information will help the patient feel less inhibited about asking questions," he says. "We hope it will encourage patients to become more involved, along with their physician, pharmacist or nurse." Tamar Nordenberg is a staff writer for FDA Consumer. ------------------------------------------------------------------------ Medication Mishaps Accupril and Accutane. The drug names sound pretty similar, but they are prescribed for very different conditions. Accupril (quinapril hydrochloride) is used to treat high blood pressure and heart failure. Accutane (isotretinoin) is for certain types of severe acne. You wouldn't want to take Accutane for a heart condition by mistake. But a patient could be given the wrong drug by accident. Confusion can arise from similar drug names or packaging, a prescriber's poor handwriting, misinterpretation of an abbreviated drug name, or an incorrect data entry into the computer. To prevent avoidable accidents, FDA's Center for Drug Evaluation and Research compares drug names to see if a change is needed to avoid confusion. "FDA's goal is to try to catch the potential for error before the product is marketed," says Sharon Smith Holston, FDA's deputy commissioner for external affairs. "Later, if we get reports of errors, we will work with the manufacturer to correct the problem by making a change in the packaging, labeling or name." Patients themselves can prevent certain types of drug errors. The National Council on Patient Information and Education recommends asking your health professional at least these six questions about a prescription medication: * What is the name of the medicine and what is it supposed to do? * How and when do I take it, and for how long? * What foods, drinks, other medicines, or activities should I avoid while taking this medicine? * Are there any side effects, and what should I do if they occur? * Will this new prescription work safely with the other prescription and nonprescription medicines I am taking? * Is there any written information available about the medicine? Patients who get drug information in writing as well as orally, says FDA pharmacist Thomas McGinnis, are much more likely to notice if the drug they got isn't for the condition they went to the doctor about or if it may be dangerous if taken with certain foods or another medication. If a medication error occurs or is suspected, a health professional may report it, in confidence, to FDA's MedWatch program at (1-800) FDA-0178 or the U.S. Pharmacopeia's Medication Errors Reporting Program at (1-800) 23-ERROR. --T.N. ------------------------------------------------------------------------ Is the Labeling Useful? To be acceptable under the action plan, the information given to patients must be scientifically accurate, unbiased, specific, complete, understandable, up-to-date, and useful. "The criteria aren't set in stone," says FDA pharmacist Thomas McGinnis. For example, the format may have to be adjusted for some populations. For the elderly, whose eyesight may be declining, the type may have to be larger. How will FDA determine if labeling is "useful"? The agency will look for specific information, including: * medicine name * critical warnings (prominently displayed) * conditions for which the product is used * circumstances under which the product shouldn't be used and directions about what to do if one of these circumstances applies (for example, "Talk to your health care professional before taking this medication if any of these apply to you.") * drugs, foods and activities that should be avoided while taking the medication, and other precautions necessary to take the medicine properly * symptoms of adverse reactions possibly related to the drug * risk, if any, of developing a drug tolerance or dependence * instructions for proper use, including the usual doses, instructions if a scheduled dose is missed, special instructions (for example, whether to take with food or water), and what to do in case of an overdose * storage instructions * general information, including a statement encouraging discussion with a health-care professional and a statement that the drug should not be given to others. * a statement that the patient labeling does not contain all possible information about the medicine and that the health-care professional has more information. ------------------------------------------------------------------------ To Get a Copy of the Action Plan Keystone Center http://www.nyam.org/keystone/ (202) 783-0248 To Get More Information About the Action Plan Kimberly Edgerly FDA Office of Consumer Affairs (HFE-88) 5600 Fishers Lane Rockville, MD 20857 (1-800) 532-4440 (10 a.m. to 4 p.m. Eastern time, Monday through Friday) ------------------------------------------------------------------------ Bulking Up Fiber's Healthful Reputation More Benefits of 'Roughage' Are Discovered by Ruth Papazian Because it causes gas, bloating, and other uncomfortable side effects, fiber may be the Rodney Dangerfield of food constituents. But with more and more research showing that a high-fiber diet may help prevent cancer, heart disease, and other serious ailments, roughage has started to get some respect. The problem is that most Americans don't get enough fiber to realize its potential benefits. The typical American eats only about 11 grams of fiber a day, according to the American Dietetic Association. Health experts recommend a minimum of 20 to 30 grams of fiber a day for most people. The Food and Drug Administration has recognized fiber's importance by requiring it to be listed on the Nutrition Facts panel of food labels along with other key nutrients and calories. And, based on scientific evidence, the agency has approved four claims related to fiber intake and lowered risk of heart disease and cancer. The most recent claim, approved in January 1997, allows food companies to state on product labels that foods with soluble fiber from whole oats may reduce heart disease risk when eaten as part of a diet low in saturated fat and cholesterol. Foods covered include rolled oats, oat bran, and whole-oat flour. FDA concluded that the beta-glucan soluble fiber of whole oats is the primary component responsible for lowering total and LDL (low-density lipoprotein), or "bad," blood cholesterol in diets including these foods at appropriate levels. This conclusion is based on a scientific review showing a link between the soluble fiber in whole-oat foods and a reduction in coronary heart disease risk. The other three claims, allowed since 1993, are: * Diets low in fat and rich in fiber-containing grain products, fruits, and vegetables may reduce the risk of some types of cancer. * Diets low in saturated fat and cholesterol and rich in fruits, vegetables, and grain products that contain fiber, particularly soluble fiber, may reduce the risk of coronary heart disease. * Diets low in fat and rich in fruits and vegetables, which are low-fat foods and may contain fiber or vitamin A (as beta-carotene) and vitamin C, may reduce the risk of some cancers. Found only in plant foods, such as whole grains, fruits, vegetables, beans, nuts, and seeds, fiber is composed of complex carbohydrates. Some fibers are soluble in water and others are insoluble. Most plant foods contain some of each kind. Some foods containing high levels of soluble fiber are dried beans, oats, barley, and some fruits, notably apples and citrus, and vegetables, such as potatoes. Foods high in insoluble fiber are wheat bran, whole grains, cereals, seeds, and the skins of many fruits and vegetables. Fiber's Health Benefits What can fiber do for you? Numerous epidemiologic (population-based) studies have found that diets low in saturated fat and cholesterol and high in fiber are associated with a reduced risk of certain cancers, diabetes, digestive disorders, and heart disease. However, since high-fiber foods may also contain antioxidant vitamins, phytochemicals, and other substances that may offer protection against these diseases, researchers can't say for certain that fiber alone is responsible for the reduced health risks they observe, notes Joyce Saltsman, a nutritionist with FDA's Office of Food Labeling. "Moreover, no one knows whether one specific type of fiber is more beneficial than another since fiber-rich foods tend to contain various types," she adds. Recent findings on the health effects of fiber show it may play a role in: * Cancer: Epidemiologic studies have consistently noted an association between low total fat and high fiber intakes and reduced incidence of colon cancer. A 1992 study by researchers at Harvard Medical School found that men who consumed 12 grams of fiber a day were twice as likely to develop precancerous colon changes as men whose daily fiber intake was about 30 grams. The exact mechanism for reducing the risk is not known, but scientists theorize that insoluble fiber adds bulk to stool, which in turn dilutes carcinogens and speeds their transit through the lower intestines and out of the body. The evidence that a high-fiber diet can protect against breast cancer is equivocal. Researchers analyzing data from the Nurses' Health Study, which tracked 89,494 women for eight years, concluded in 1992 that fiber intake has no influence on breast cancer risk in middle-aged women. Previously, a review and analysis of 12 studies found a link between high fiber intake and reduced risk. In the early stages, some breast tumors are stimulated by excess amounts of estrogen circulating in the bloodstream. Some scientists believe that fiber may hamper the growth of such tumors by binding with estrogen in the intestine. This prevents the excess estrogen from being reabsorbed into the bloodstream. * Digestive disorders: Because insoluble fiber aids digestion and adds bulk to stool, it hastens passage of fecal material through the gut, thus helping to prevent or alleviate constipation. Fiber also may help reduce the risk of diverticulosis, a condition in which small pouches form in the colon wall (usually from the pressure of straining during bowel movements). People who already have diverticulosis often find that increased fiber consumption can alleviate symptoms, which include constipation and/or diarrhea, abdominal pain, flatulence, and mucus or blood in the stool. * Diabetes: As with cholesterol, soluble fiber traps carbohydrates to slow their digestion and absorption. In theory, this may help prevent wide swings in blood sugar level throughout the day. Additionally, a new study from the Harvard School of Public Health, published in the Feb. 12 issue of the Journal of the American Medical Association, suggests that a high-sugar, low-fiber diet more than doubles women's risk of Type II (non-insulin-dependent) diabetes. In the study, cereal fiber was associated with a 28 percent decreased risk, with fiber from fruits and vegetables having no effect. In comparison, cola beverages, white bread, white rice, and french fries increased the risk. * Heart Disease: Clinical studies show that a heart-healthy diet (low in saturated fat and cholesterol, and high in fruits, vegetables and grain products that contain soluble fiber) can lower blood cholesterol. In these studies, cholesterol levels dropped between 0.5 percent and 2 percent for every gram of soluble fiber eaten per day. As it passes through the gastrointestinal tract, soluble fiber binds to dietary cholesterol, helping the body to eliminate it. This reduces blood cholesterol levels, which, in turn, reduces cholesterol deposits on arterial walls that eventually choke off the vessel. There also is some evidence that soluble fiber can slow the liver's manufacture of cholesterol, as well as alter low-density lipoprotein (LDL) particles to make them larger and less dense. Researchers believe that small, dense LDL particles pose a bigger health threat. Recent findings from two long-term large-scale studies of men suggest that high fiber intake can significantly lower the risk of heart attack. Men who ate the most fiber-rich foods (35 grams a day, on average) suffered one-third fewer heart attacks than those who had the lowest fiber intake (15 grams a day), according to a Finnish study of 21,903 male smokers aged 50 to 69, published in the December 1996 issue of Circulation. Earlier in the year, findings from an ongoing U.S. study of 43,757 male health professionals (some of whom were sedentary, overweight or smokers) suggest that those who ate more than 25 grams of fiber per day had a 36 percent lower risk of developing heart disease than those who consumed less than 15 grams daily. In the Finnish study, each 10 grams of fiber added to the diet decreased the risk of dying from heart disease by 17 percent; in the U.S. study, risk was decreased by 29 percent. These results indicate that high-fiber diets may help blunt the effects of smoking and other risk factors for heart disease. * Obesity: Because insoluble fiber is indigestible and passes through the body virtually intact, it provides few calories. And since the digestive tract can handle only so much bulk at a time, fiber-rich foods are more filling than other foods--so people tend to eat less. Insoluble fiber also may hamper the absorption of calorie-dense dietary fat. So, reaching for an apple instead of a bag of chips is a smart choice for someone trying to lose weight. But be leery of using fiber supplements for weight loss. In August 1991, FDA banned methylcellulose, along with 110 other ingredients, in over-the-counter diet aids because there was no evidence these ingredients were safe and effective. The agency also recalled one product that contained guar gum after receiving reports of gastric or esophageal obstructions. The manufacturer had claimed the product promoted a feeling of fullness when it expanded in the stomach. An Apple a Day and More Recent research suggests that as much as 35 grams of fiber a day is needed to help reduce the risk of chronic disease, including heart disease. A fiber supplement can help make up the shortfall, but should not be a substitute for fiber-rich foods. "Foods that are high in fiber also contain nutrients that may help reduce the risk of chronic disease," Saltsman notes. In addition, eating a variety of such foods provides several types of fiber, whereas some fiber supplements contain only a single type of fiber, such as methylcellulose or psyllium. To fit more fiber into your day: * Read food labels. The labels of almost all foods will tell you the amount of dietary fiber in each serving, as well as the Percent Daily Value (DV) based on a 2,000-calorie diet. For instance, if a half cup serving of a food provides 10 grams of dietary fiber, one serving provides 40 percent of the recommended DV. The food label can state that a product is "a good source" of fiber if it contributes 10 percent of the DV--2.5 grams of fiber per serving. The package can claim "high in," "rich in" or "excellent source of" fiber if the product provides 20 percent of the DV--5 grams per serving. * Use the U.S. Department of Agriculture's food pyramid as a guide. If you eat 2 to 4 servings of fruit, 3 to 5 servings of vegetables, and 6 to 11 servings of cereal and grain foods, as recommended by the pyramid, you should have no trouble getting 25 to 30 grams of fiber a day. * Start the day with a whole-grain cereal that contains at least 5 grams of fiber per serving. Top with wheat germ, raisins, bananas, or berries, all of which are good sources of fiber. * When appropriate, eat vegetables raw. Cooking vegetables may reduce fiber content by breaking down some fiber into its carbohydrate components. When you do cook vegetables, microwave or steam only until they are al dente--tender, but still firm to the bite. * Avoid peeling fruits and vegetables; eating the skin and membranes ensures that you get every bit of fiber. But rinse with warm water to remove surface dirt and bacteria before eating. Also, keep in mind that whole fruits and vegetables contain more fiber than juice, which lacks the skin and membranes. * Eat liberal amounts of foods that contain unprocessed grains in your diet: whole-wheat products such as bulgur, couscous or kasha and whole-grain breads, cereals and pasta. * Add beans to soups, stews and salads; a couple of times a week, substitute legume-based dishes (such as lentil soup, bean burritos, or rice and beans) for those made with meat. * Keep fresh and dried fruit on hand for snacks. "So many foods contain fiber that it's really not that hard to get your intake up where it should be," Saltsman says. Ruth Papazian is a writer in Bronx, N.Y., specializing in health and safety issues. ------------------------------------------------------------------------ Slow Going A word of caution: When increasing the fiber content of your diet, it's best to take it slow. Add just a few grams at a time to allow the intestinal tract to adjust; otherwise, abdominal cramps, gas, bloating, and diarrhea or constipation may result. Other ways to help minimize these effects: * Drink at least 2 liters (8 cups) of fluid daily. * Don't cook dried beans in the same water you soaked them in. * Use enzyme products, such as Beano or Say Yes To Beans, that help digest fiber. --R.P. ------------------------------------------------------------------------ Incontinence Can Be Controlled by Carolyn J. Strange No one wants to talk about it. Patients don't bring it up. Physicians don't ask. Meanwhile, millions suffer in silence as urinary incontinence erodes their quality of life. When it is discussed, all too often, patients are told--incorrectly--that it's a normal consequence of aging and that they should just get used to it. Misconceptions about incontinence abound among health-care professionals and the public alike. At least 13 million Americans experience urinary incontinence, the involuntary leakage of urine sufficient to be a problem, and 11 million of them are women, according to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Incontinence is also more common in older people. It's not surprising that about half of nursing home residents are incontinent since it's a major cause of institutionalization, according to numerous sources. But that doesn't mean it's a normal part of being a woman or of aging. "Incontinence is never normal at any age," says Neil Resnick, M.D., chief of gerontology at Brigham and Women's Hospital, Boston, and an associate professor of medicine at Harvard Medical School. "It's treatable in the vast majority of people, most of whom have full continence restored. Most of the remaining people can at a minimum be improved," he says. Despite its prevalence, urinary incontinence is widely underdiagnosed and underreported, and many health-care providers remain uneducated about it, according to a 1996 clinical practice guideline update from the Agency for Health Care Policy Research. It's also expensive. Americans spent about $27.8 billion on incontinence in 1995, according to NIDDK. The health-care impact is likely to increase as the baby boomers age. Fortunately, the outlook is improving. This new generation of patients is less willing to let shame and embarrassment silence them, some doctors say. And there are more treatment options than ever before, including two new devices FDA approved just last summer. Treatment can improve the quality of life for millions of people. "Patients are so overwhelmingly grateful--it's a thrill," says James M. Cummings, M.D., assistant professor of surgery in the division of urology at Saint Louis University School of Medicine. "Even if you only improve them some, even if you don't make them dry, they're still very grateful because they see a big difference in their lives." Quality of Life That's important because a variety of medical, emotional and social problems often accompany incontinence. Rashes, skin infections, pressure sores, and urinary tract infections are among the complications that can result from incontinence. More devastating are sleep disturbances, restricted social interactions, reduced sexual activity, loss of self-esteem, and depression. Employment may become difficult or impossible. Some people quit going out altogether, and many of the joys of life fade away. "This is a problem of major magnitude, even though it's not something people die from like cancer or heart disease," Cummings says. Traditionally, people with incontinence have turned to various absorbent products, as well as deodorants, disinfectants, and skin-care products. The average person with incontinence spends $3,941 annually on the problem, according to NIDDK. Experts emphasize that absorbent products are not the only recourse for incontinence. Although absorbent products can be used as adjuncts to treatment or when treatments fail, people should understand the various treatment and management options available to them. Then, in consultation with their physicians, patients can decide which options best suit their lifestyle. Also, dependence on absorbent products may decrease a person's motivation to seek medical help. That delay could be dangerous because certain serious conditions can cause incontinence--for example, tumors of the brain, spinal cord, bladder, or prostate. These tumors aren't common, but they're treatable only if found early. In any case, incontinence is a symptom that something has gone wrong. Water Works Normally, the kidneys continually filter blood, removing waste and producing urine, which travels down tubes called ureters into the bladder, a muscular sac behind the pelvic bone. The bladder expands to store urine and contracts to expel it. The tube that empties the bladder is the urethra. A valve-like sphincter muscle encircles the top of the urethra at the bladder neck, preventing leakage. Spinal nerves coordinate the actions of the bladder and the sphincter. Infants empty their bladders by reflex. When the bladder fills and stretches beyond a certain point, it signals the spinal cord, which triggers the sphincter to relax and the bladder to contract. Young children gradually develop control over this process. Bladder stretching registers consciously as discomfort, and the brain learns to suppress the reflex. The more the bladder stretches, the more urgent the desire to urinate. Incontinence can occur for many reasons. Urinary tract infections, vaginal infection or irritation, constipation, and certain medications may cause temporary incontinence. A variety of other problems can cause persistent incontinence: weakness of the bladder, the sphincter, or the muscles that support the bladder; overactive bladder muscles; a blocked urethra (from prostate enlargement or surgery); neurologic disorders; and immobility. Anything that damages the nerves or muscles at the bottom of the pelvis, or the pelvic floor, increases the risk. Anatomical differences between the sexes affect the underlying causes and the tendency for certain types of incontinence to develop. There are several types of incontinence: * Stress incontinence, the most prevalent type, is common in women who have gone through childbirth because the muscles have been stretched. As the name suggests, urine may escape during a cough, laugh, sneeze, or any activity that temporarily increases pressure within the abdomen and thus on the bladder--even if the bladder isn't full. * Urge incontinence is the involuntary loss of urine associated with a strong desire to urinate. The person can't control urination long enough to get to the toilet in time. * Mixed incontinence, the coexistence of stress and urge incontinence, is more common in older women. Often one is more bothersome than the other. * Overflow incontinence is the result of chronic urine retention in people who can't empty their bladders. The bladder is always full, leading to frequent or constant dribbling. It's more common in men, often because of an obstruction such as an enlarged prostate. Removing the obstruction restores continence. This type of incontinence can also occur as a result of nerve damage. * Unconscious or reflex incontinence is the loss of urine without warning or sensory awareness. It's usually the result of neurological disease or injury. * Functional incontinence occurs in people with normal urinary control who can't get to the toilet in time because their movement is slowed by arthritis or other physical or mental disorders. Diagnosis and Treatment The first step toward successful treatment is to determine the type of incontinence and the cause. A doctor's evaluation usually includes a physical examination, medical history, and urine tests. The patient may be asked to keep a bladder record and may be referred to a urologist or urogynecologist for more specialized follow-up testing. Treatment options fall into four broad categories--behavioral, devices, medications, and surgery. Generally, those options that are least invasive, dangerous or expensive are tried first. Behavioral options require patients to learn new behaviors to help them regain control over urination. Behavioral methods work best with motivated patients willing to invest time and effort. Success rates are high for those who persist--most improve and many become dry. Behavioral treatments are generally free of side effects, noninvasive, and don't limit further treatment options. For people with urge incontinence, bladder or habit training can help reassert control over the bladder. The patient is instructed to urinate at intervals, say, every hour or so. After achieving dryness for a few days, the interval increases. This cycle continues until the patient attains an acceptable interval of several hours. Other steps may include eliminating dietary caffeine and reducing fluids in the evening to improve sleep. Limiting overall fluid intake is not recommended, however, to avoid dehydration. The goal with stress incontinence is to increase resistance in the sphincter and urethra. Most women see significant improvement, and many achieve dryness, with pelvic muscle exercises (PMEs), also known as Kegel exercises. PMEs are performed by tightening the pelvic floor muscles as if to control urination or defecation. Patients are generally told to sustain a contraction for at least 10 seconds, followed by an equal period of relaxation. The exercises should be performed about 30 to 80 times a day for at least eight weeks. Older adults may require longer training. Sometimes PMEs are combined with biofeedback to help establish better awareness of muscle function. "Patients should not give up on the exercises too quickly," stresses Rao Nimmagadda, Ph.D., in FDA's urology devices branch. It may take awhile to determine whether PMEs help. And, as with any exercise program, the beneficial effects last only as long as the exercise continues. For some people, electrostimulation via a small rectal or vaginal probe may help in building or maintaining muscle tone. These devices passively exercise the pelvic floor muscles with painless electrical pulses. New Devices Two new treatment methods became available last summer, when FDA reviewed for marketing two new prescription devices for stress incontinence in women. UroMed Corp., of Needham, Mass., makes both the Reliance Urinary Control Insert, sometimes called a urethral plug, and the Miniguard Patch. The Reliance Insert is a single-use, balloon-tipped cylinder about one-fifth the size of a tampon that's placed in the urethra with an applicator. A gentle push fills the small balloon inside the bladder with air. The balloon holds the device in place and prevents leakage. When the woman wishes to urinate, she pulls a string to deflate the balloon, then removes the insert. After urinating she may insert a new device. Since the device is inserted into the urethra, it is associated with a fairly high infection rate. According to the manufacturer, urinary tract infections were more common during the first month of the trial and diminished as women learned how to use the device. "It's not for everybody. It has to be individualized," says Grannum Sant, M.D., chair of urology, Tufts University School of Medicine, in Boston, who helped test the device. For women in the clinical trial, inserting the device became easy, Sant says, and their quality of life improved considerably as they resumed aerobics, biking, dancing, and other physical and social activities. Many women, Sant says, will probably use the device only during activities they know cause leakage. "In real life it's not going to be used constantly around the clock like we did in the study. Therefore the complication rate and discomfort rate--which was acceptable--is going to be even less," Sant says. The other new device, the Miniguard Patch, is expected to be on the market later this year. It is a completely external, single-use foam pad a little bigger than a postage stamp. The patch is coated with a gel-like adhesive on one side and fits between the labial folds over the opening of the urethra, where it provides opposing pressure and a barrier to leakage. The patch is removed for urination and a new one applied afterwards. For women used to wearing cumbersome pads, "The patch is a neater way of doing it. They don't feel so bulky," says Patricia Burns, Ph.D., a registered nurse and dean of the School of Nursing at the University of South Florida, in Tampa. Burns, who also maintains an incontinence practice, helped test the device. Other Treatments Medications are another treatment option. "I found in my practice that a lot of people can be treated with medication," says Dan Shames, M.D., a urologist in FDA's reproductive and urologic drug products division who had a clinical practice for nearly 20 years. In general, the drugs available are approved only for urge incontinence. These include anticholinergics, such as propantheline, and antispasmodics such as oxybutynin. They work by relaxing the bladder muscles to stop abnormal contractions. Unfortunately, some drugs have numerous side effects, such as severe dry mouth, blurred vision, and constipation. "A lot of people stop using them because they can't handle the side effects at the level that gives them relief," Shames says. But, he adds, drug companies are trying to develop drugs that work as well or better with fewer adverse effects. "There are more approval requests for new drugs for incontinence," he says. Some women don't experience incontinence until after menopause, and for them estrogen replacement may help. The hormone estrogen plays a role in keeping the lining of the urethra plump and toned. In some cases, surgery to correct anatomical problems or implant devices remains the best treatment. Most people do not need surgery, but of those who do most become continent again. For example, surgery can remove blockages. Or sometimes collagen is injected around the urethra. Collagen, a naturally occurring structural protein, is used to add bulk to the surrounding tissue, thus narrowing the urethra and increasing resistance to urine flow. This method seems to work better in women. For women with stress incontinence, other surgery options include improving the bladder neck position, and supporting or replacing severely weakened pelvic muscles. People with extremely small bladders may be candidates for an enlargement operation. Implanting an artificial urinary sphincter may be appropriate in some people. For people who are incontinent because of faulty nerves to the bladder, an implanted stimulation device is under investigation. A last alternative is one of two types of catheters. Both are placed into the bladder through the urethra to drain the bladder. The Foley catheter is left in place; with an intermittent catheter, the patient inserts it as needed. Education Is Key Despite how prevalent and treatable incontinence is, a variety of national and international professional organizations, including the National Institutes of Health, have noted a lack of professional and public knowledge about incontinence and its treatment. "Most physicians have never had any education about incontinence," Resnick says. Sant agrees, but he has noticed the beginning of an encouraging trend. "We're seeing a change in the approach, not only on the part of physicians, but also in the expectations and demands of the patients--which I think is excellent," Sant says. "Women are now saying, 'Look, we don't have to live with this.'" Apparently, the word is spreading that incontinence is neither inevitable nor shameful but instead treatable or, at least, manageable. Carolyn J. Strange is a science and medical writer living in Northern California. ------------------------------------------------------------------------ Facing Facts About Urinary Incontinence Myth: There's nothing that can be done about it. Fact: There's a lot that can be done. In the majority of cases, continence can be restored or improved with behavioral techniques, devices, drugs, or surgery. Myth: Incontinence is a normal consequence of aging. Fact: Incontinence is never normal at any age, according to Neil Resnick, M.D., chief of gerontology at Brigham and Women's Hospital, Boston. Age-related changes in the lower urinary tract may make older people more likely to experience incontinence, but for most older people, even the very old and frail, incontinence can be treated successfully. Myth: The only successful treatment is surgery. Fact: The majority of patients can be helped with other treatments. Myth: Incontinence is inevitable for women who have given birth. Fact: Giving birth can injure or weaken the pelvic region, but that doesn't mean incontinence is inevitable. Exercises often help. Myth: A little leakage sometimes, such as during a sneeze or cough, is no big deal. It's not worth telling the doctor about. Fact: If urinary leakage is troubling at all, it's worth mentioning to the doctor. People can learn to manage the problem--or be free of it altogether. ------------------------------------------------------------------------ Where to Turn for Help Here are some organizations that can give additional information and support. National Association For Continence (formerly Help for Incontinent People) P.O. Box 8310 Spartanburg, SC 29305-8310 (1-800) BLADDER http://www.nafc.org/ Simon Foundation for Continence Box 815 Wilmette, IL 60091 (1-800) 23-SIMON Agency for Health Care Policy and Research Publications Clearinghouse P.O. Box 8547 Silver Spring, MD 20907 (1-800) 358-9295 http://www.ahcpr.gov/ National Kidney and Urologic Diseases Information Clearinghouse 3 Information Way Bethesda, MD 20892-3580 (301) 654-4415 http://www.niddk.nih.gov/Brochures/NKUDIC.htm (The source for the illustration in this article was The American Medical Association Encyclopedia of Medicine, 1989) ------------------------------------------------------------------------ Attention Disorder: Overcoming the Deficit Abuse of Attention Deficit Drug Can Be Deadly by Dixie Farley "I really see a difference in my grades. Without it, I don't think about things. I can't pay attention." --Christy Rade, 16, Des Moines, Iowa, commenting in the Aug. 26, 1996, Des Moines Register on her treatment for attention-deficit/hyperactivity disorder (ADHD) with Ritalin, the brand name for the stimulant medicine methylphenidate. "Teens Learn Dangers of Ritalin Use; 19-Year-Old Man Dies After Snorting Stimulant at Party" --a headline in the April 24, 1995, Roanoke Times & World News, Roanoke, Va. If, like Christy Rade, you're taking stimulant medicine for ADHD, you are not alone. In mid-1995, about 1.5 million school-age youngsters did so, reported Daniel Safer, M.D., and colleagues in Pediatrics, December 1996. But, as the Virginia headline points out, abuse of this medicine can be deadly. In ADHD, brain areas ruling attention and inhibition don't work very well. Most children with ADHD are inattentive, impulsive and hyperactive. In teenagers, the hyperactivity often quiets to a restlessness. For some, paying attention is their biggest problem. Others are mainly impulsive and hyperactive. The Food and Drug Administration has approved several stimulant medicines for treating ADHD: methylphenidate (Ritalin and generics), dextroamphetamine (Dexedrine and generics), methamphetamine (Desoxyn), and an amphetamine-dextroamphetamine combination (Adderall). FDA recently restricted another approved stimulant, pemoline (Cylert), to secondary use, as it can cause liver failure. The drugs stimulate the central nervous system, but no one knows exactly how they work in treating ADHD. "Stimulants have been used to treat ADHD for over three decades," says Nicholas Reuter, FDA associate director for international and domestic drug control affairs. "And the amount used has increased steadily during that period. Methylphenidate is the most widely used." Not everyone with ADHD requires or responds to stimulant treatment. Risk of Abuse Because stimulant medicines have a high potential for abuse, the U.S. Drug Enforcement Administration has placed stringent controls on their manufacture, distribution and prescription. For example, DEA requires special licenses for these activities, and prescription refills aren't allowed. States may impose further regulation, like limiting the number of dosage units per prescription. DEA has repeatedly urged greater caution in use of these drugs, especially in light of their abuse among adolescents and young adults. Ritalin's manufacturer, Ciba-Geigy Corp., began a campaign in March 1996 to reduce abuse. In nationwide mailings to doctors and pharmacists, the firm called attention to the risk of abuse and cautioned doctors to be especially careful in diagnosing ADHD. Enclosed were behavior rating scales for doctors to use and handouts for patients, parents and school nurses. Taken properly, Ritalin in and of itself is not addictive, says Wendy Sharp, M.S.W., a social worker and researcher at the National Institute of Mental Health's child psychiatry branch. So people with ADHD do not get addicted to their stimulant medicine at treatment dosages, she says. "There have been unfortunate cases reported in the press, however, of teenagers who have taken Ritalin from other kids and snorted it, like cocaine." According to Reuter, "Although methylphenidate production and availability have increased dramatically since 1990, national drug abuse surveys indicate that the abuse level and associated public health consequences remain below that of other stimulant medicines such as cocaine, amphetamine and methamphetamine." Patricia Quinn, M.D., a developmental pediatrician in Washington, D.C., and author of many books on ADHD, adds, "There's actually less substance abuse in people diagnosed with attention deficit disorder who take medication and do well than in the general population. Adolescents I've worked with are trying to straighten out what's going on." Diagnosing Difficulties About 30 percent of young people with ADHD aren't diagnosed until middle school or later, says Quinn. These students are very bright, she says. "The more intelligent you are, the better you cope--until stressors in the environment outpace your ability to cope. Maybe your disorder becomes a problem in high school when you have only lecture classes, or in college when you have to do everything for yourself and go to class, too." By the time someone with undiagnosed ADHD gets to middle school or high school, the main complaint is classroom underachievement rather than hyperactivity or distractibility, Quinn says. Some people shorten the name to ADD when it affects older people. "But you shouldn't assume that everyone who is underachieving has ADHD." And, not everyone with attention difficulty has ADHD. For example, when Linda Smith (not her real name) was 16, she had extreme difficulty concentrating. ADHD was suspected. Thorough examination, however, revealed the culprits were anxiety, depression and a sleep disorder, which are improving under a treatment plan that includes medicines and counseling. Narrowing a diagnosis to ADHD requires more than a single visit to the doctor. Substantial detective work by the doctor involves talking not only to the patient, but also to the parents and to nurses and teachers at the patient's various schools. "I ask to see all report cards from kindergarten on," Quinn says. "Teachers usually comment, 'He would do so much better if he could only pay attention.' One mother said of her son in high school, 'One day in first grade, he came home without shoes. He didn't know where he put them.' Kids with this disorder lose their jackets, shoes. So he had symptoms early on." There is no biological test for ADHD. Doctors base their diagnosis on guidelines set by the American Psychiatric Association. (See "Diagnostic Guidelines.") Deciding to Use Stimulants Stimulant treatment begins as a "trial," so you and your parents should tell the doctor regularly about improvements, such as handling school tasks better, and any side effects. The most common side effects are nervousness, sleep difficulty, and appetite loss. Less common are skin rash, nausea, dizziness, headache, weight loss, and blood pressure changes. Immediately report such serious effects as confusion, breathing difficulty, sweating, vomiting, and muscle twitches, which may signal too high a dose. With this information and further examination, the doctor can determine the most effective dose that causes no, or only tolerable, side effects. Patients who need stimulant medicine only for paying attention may not need it at all during weekends and summer vacations. If their difficult subjects are in the morning, a morning dose may be enough most days. Other patients need stimulant medicine much more often. Stimulants are not for everyone with ADHD. For example, they shouldn't be used in someone with marked agitation, a twitching known as a tic, or the eye disorder glaucoma. And like all medicine, stimulants pose risks. Whether to use stimulants is a case-by-case decision based on how the benefit stacks up against the risk. In January 1996, FDA announced that in studies of rodents given methylphenidate, the drug produced a "weak signal" for the potential to cause liver cancer. The cancer occurred in male mice but not in female mice or rats. At FDA's request, Ciba-Geigy informed doctors and, along with other methylphenidate manufacturers, added the findings to their drugs' labeling. Accompanying health problems like depression may require other medicines or psychotherapy. "Individual therapy for ADHD may not be helpful," Sharp says. "Probably the most beneficial treatment for ADHD involves the entire family system, and behavior management is usually a large part of this treatment." Some people have linked ADHD to sugar and food or color additives. "Research in this area has raised questions and contributes to understanding," says Catherine Bailey, an FDA science policy analyst. "But the idea that individual food substances cause ADHD is unproven. Still, if people want to avoid substances they perceive as problems, they should be sure to read food labels." Moving Forward Scientists don't know exactly what causes ADHD, but it tends to affect several in a family. When an identical twin has ADHD, the other usually does, too. Sharp had recruited twins for research to help clarify this. While more males than females have ADHD, the gender gap is narrowing. Males taking medicine for the disorder outnumbered females 10 to 1 in 1985 but only 5 to 1 in 1995, the authors of the 1996 Pediatrics article stated. Probably the hardest part of having ADHD is accepting the diagnosis, Quinn says. She stresses the importance of looking at everything else that's good in your life. "The disorder is part of who you are and, yes, you have to control it," she says. "But it doesn't define you. It's okay to have attention disorder, so long as you know what to do about it." Dixie Farley is a staff writer for FDA Consumer. ------------------------------------------------------------------------ Helping Yourself The first step toward dealing successfully with ADHD is to learn as much as you can about the disorder, the pros and cons of stimulant treatment, and strategies for self-help. If you have ADHD, self-help skills can be critical to your success in high school and college, and later on with your career. In her book Adolescents and ADD, Gaining the Advantage, developmental pediatrician Patricia Quinn, M.D., advises, "Set realistic goals. Be honest about your strengths and weaknesses." These tips from her book may help. Taking Responsibility Talk to the school nurse. * Bring up your concerns. * Ask if students with ADHD meet to share ideas. If not, ask how to start a group. * Ask the nurse to help your teachers understand your diagnosis and provide classroom support, such as more time for tests and a front seat away from distractions. People with disabilities or certain impairments are entitled to free, appropriate public education under the Individuals with Disabilities Education Act of 1990, Section 504 of the Rehabilitation Act of 1972, and the Americans with Disabilities Act of 1990. If your ADHD isn't being accommodated under these laws, ask the school nurse how to find out if it can be. Be careful taking medicine. * Ask about your school's policy on taking medicines at school. * When parents deliver your medicine, be sure the prescription label lists your name, diagnosis, medicine name, dose, and, especially, when to take it. * Until taking doses on time gets routine, make notes to yourself or set your watch alarm. * To prevent mix-ups, always tell the person giving you the medicine your full name, see that the bottle is yours, and make sure you get the correct number of tablets. * Report side effects to your parents or the nurse. * Never "help out" someone else by sharing your medicine. Improving School Work Manage note-taking. * Write on every other line to leave room for ideas you might add later. * Leave out unimportant words, like "the" and "an." * List some abbreviations of your own at the front of your notebook for reference. * Ask a friend to take notes over carbon paper to provide a copy for you. * Ask teachers to let you have a copy of their notes. * Make an audio-cassette recording of lectures, especially before tests. Understand what you read. * Read while you are fresh. * Decide what you're looking for. Then skim the material, noting pictures and graphs and reading the headings and bold print. * List unfamiliar words, then look them up. Get help if you don't understand a meaning. * Read assigned questions before the material. Then write answers as you read along. * Highlight or underline important information on your study sheets. * Read the material again. Improve written assignments. * Use a computer with a spell-check. Writing on a computer can also help you organize your thoughts. * To check spelling without a computer, start at the bottom of the page and move up. Improve math assignments. * If you start to feel lost in a unit, tell your teacher, advisor or tutor immediately, as each new math concept builds on what you've already learned. * Leave space between examples. Line up the numbers in columns carefully. * Check each math solution before handing it in, especially on tests. * Practice math in the summer with worksheets or summer school. Study smarter. * Study with a partner. * Use your textbook's headings and subheadings for a study outline. * Put important information on cards or audiotape for reviewing. * Organize your notes and worksheets by topic. Study some each night. * Allow two nights for review before a test. * Get plenty of sleep the night before a test. * If you get anxious when you can't answer a test question, stop and take deep breaths. Then jot down some facts you do know, which may trigger the answer. * Discuss your school routine and grades with your advisor weekly or even daily. (Adolescents and ADD, Gaining the Advantage is published by Magination Press, New York, N.Y.; telephone 1-800-825-3089.) ------------------------------------------------------------------------ Diagnostic Guidelines According to the American Psychiatric Association, a diagnosis of ADHD must meet the following guidelines: * The patient must often have: either six of these inattention symptoms: * does not pay close attention to details or makes careless mistakes * has difficulty sustaining attention in activities * does not seem to listen when spoken to directly * does not follow through on instructions and fails to finish duties * has difficulty organizing tasks and activities * avoids, dislikes, or is reluctant to do tasks requiring sustained mental effort * loses things necessary for tasks or activities * is easily distracted * is forgetful in daily activities or six of these hyperactivity or impulsiveness symptoms: * fidgets with hands or feet or squirms in seat * leaves seat in classroom or other times when remaining seated is expected * inappropriately runs about or climbs excessively or, in older patients, feels restless * has difficulty playing or taking part in leisure activities quietly * is "on the go" or acts as if "driven by a motor" * talks excessively * blurts out answers before questions have been completed * has difficulty awaiting turn * interrupts or intrudes on others, such as butting into conversations or games. * Symptoms must continue six months and be more frequent and severe than normal. * Evidence must show significant damage to social, academic or work functioning. * Some damage must occur in at least two settings, such as home and school. * Some damaging symptoms must have occurred before age 7, even with a later diagnosis. * The symptoms must not be due to another disorder. ------------------------------------------------------------------------ More Information ADD Warehouse (1-800) 233-9273 World Wide Web: http://www.addwarehouse.com/ Attention Deficit Information Network 475 Hillside Ave., Needham, MA 02194 (617) 455-9895 Children and Adults with Attention Deficit Disorders 499 N.W. 70th Ave., Suite 101, Plantation, FL 33317 (1-800) 233-4050 World Wide Web: http://www.chadd.org/ National Attention Deficit Disorder Association (1-800) 487-2282 World Wide Web: http://www.add.org/ National Institute of Neurological Disorders and Stroke (1-800) 352-9424 World Wide Web: http://www.ninds.nih.gov/ National Institute of Mental Health Room 7C-02, 5600 Fishers Lane, Rockville, MD 20857 (301) 443-4513 World Wide Web: http://www.nimh.nih.gov/ ------------------------------------------------------------------------ Updates Court Upholds FDA Authority To Regulate Tobacco Products FDA has the authority under the Federal Food, Drug, and Cosmetic Act to regulate cigarettes and smokeless tobacco, but not their advertising and promotion, according to a recent federal court decision. Several companies, including cigarette and smokeless tobacco manufacturers and sellers, had sued FDA regarding its rule on children and tobacco. Judge William Osteen of the U.S. District Court for the Middle District of North Carolina ruled on April 25 that FDA may: * prohibit the sale of cigarettes and smokeless tobacco products to minors * require retailers to check the photo I.D. of purchasers under age 27 * prohibit self-service displays and vending machines where children can access them * prohibit free cigarette samples * prohibit the sale of "kiddie packs" of less than 20 cigarettes * require a statement on cigarette and smokeless tobacco packages of the product's established name, intended use, and age restriction. The first two provisions took effect Feb. 28. The rest were scheduled to go into effect Aug. 28 but have been put on hold pending further orders by the court. The government has appealed the court's finding that FDA lacks the authority to regulate the advertising and promotion of tobacco products. "This is a fight we cannot afford to lose," President Clinton said on the day of the court decision. Each day, Clinton said, 3,000 young people become regular smokers, and 1,000 of them will have their lives cut short as a result. New NCI Recommendations For Mammography Screening The National Cancer Institute has issued updated recommendations for mammography screening to detect breast cancer. Mammography is x-ray examination of the breast. According to the new recommendations: * Women 40 to 49 should have mammography screening every one to two years if they are at average risk for breast cancer. * Women 50 and older also should be screened every one to two years. * Women at higher risk of breast cancer should seek expert medical advice about possible screening before age 40 and about the frequency of screening. * Along with mammograms, a clinical breast examination by a health-care provider should be included as part of regular, routine health care. Breast cancer is the second leading cause of cancer deaths in American women; about 44,000 women are expected to die from the disease this year. Performed correctly, mammography is the most effective way to detect breast cancer early, often locating small tumors that cannot yet be detected by touch. High-quality mammography can find 85 to 90 percent of breast tumors in women over 50. Widespread screening of women this age, followed by prompt treatment when needed, can reduce cancer deaths by up to 30 percent. Also, if the cancer is detected early enough, before it has spread, the woman may choose treatment that preserves her breast. Because of concerns about inadequate mammography quality at some facilities, Congress in 1992 passed the Mammography Quality Standards Act. Facilities now must be certified by FDA as having met quality standards for x-ray images, equipment, and personnel and must be inspected annually. (See "Mammography Facilities Must Meet Quality Standards" in the March 1994 FDA Consumer.) Legislation was introduced in April to reauthorize the act, which will otherwise expire this year. FDA has certified more than 10,000 mammography facilities. For a list of their names and locations, go to http://www.fda.gov/cdrh/faclist.html on FDA's Web site. Or call the National Cancer Institute's toll-free cancer information service at (1-800) 4-CANCER. Laser Treatments OK'd For Tooth Decay, Astigmatism Less dental pain and fewer eyeglasses. That may be the result with two new medical uses for lasers now available: the first dental laser for use directly on teeth to treat tooth decay and a laser, already approved for some nearsightedness cases, to treat astigmatism. FDA cleared the erbium YAG laser system for marketing May 7 to remove tooth decay, prepare cavities for fillings, and roughen enamel to improve bonding of restorations. Previous dental lasers were cleared for use only on soft tissue like the gums, for curing restorations, and as the heat source in some bleaching systems. (See "Lasers in Dentistry" in the January-February 1995 FDA Consumer.) In one study by the manufacturer, Premier Laser Systems, of Irvine, Calif., more than 500 teeth were treated for decay with the laser and then evaluated for damage to the tooth's nerve and blood supply. No adverse events were reported. A second controlled study by the firm involved some 125 patients with tooth decay. Half were treated with the laser, and half with a high-speed drill. The laser was as safe and effective as the drill in removing decay and preparing the teeth for fillings, but patients treated with the laser were less likely to need anesthetic for pain. The laser system consists of a box-like laser console and a fiber-optic cable with a dental handpiece at the end resembling a standard high-speed drill. Like dental drills, the laser uses water or air to cool the tooth and clean the surface during treatment. Dentists and patients will need to wear goggles to protect their eyes. FDA approved the Visx Inc. excimer laser April 24 for refractive surgery to treat mild to moderate astigmatism in people 21 and older who also have mild to moderate nearsightedness. Most nearsighted people also have astigmatism, which prevents correct focusing. It is caused by uneven curvature of the surface of the eye's cornea. The laser is not approved for severe cases of these disorders. (See also "Not a Cure-All: Eye Surgery Helps Some See Better" in the July-August 1995 FDA Consumer.) FDA restrictions for the laser include: * Users must be medical practitioners who are experienced in corneal surgery and trained in laser refractive surgery for nearsightedness and astigmatism and in the calibration and use of the laser. * Patients considering the surgery must be given the manufacturer's patient information booklet reviewed by FDA that describes the procedure's risks and benefits. * Before surgery, patients must be told about correction alternatives, including eyeglasses, contact lenses, and other types of surgery. * In advertising and promoting the laser, the manufacturer may not compare it to any other laser or any other correction for nearsightedness or astigmatism. Visx Inc. is located in Santa Clara, Calif. Nicotine Inhaler Approved for Smoking Cessation Smokers fighting the urge to light up have a new addition in the smoking cessation arsenal--a prescription nicotine inhaler. The Nicotrol Inhaler (nicotine inhalation system) allows smokers to inhale the dose from a nicotine cartridge through a plastic mouthpiece. The nicotine is absorbed into the body through the mucous membranes of the mouth. While the inhaler's ability to satisfy smokers' psychological needs for the ritual of bringing hand to mouth is unknown, quit rates in clinical trials with the inhaler were comparable to other smoking cessation products already on the market. The Nicotrol Inhaler, approved by FDA May 2, is manufactured by Pharmacia & Upjohn Inc., Kalamazoo, Mich., and marketed by McNeil Consumer Products, Fort Washington, Pa. Temporary Wound Cover from Human Cells Approved The first wound covering made with human cells has been approved by FDA to temporarily cover severe burn wounds until a patient's own skin can be transplanted. Each year, about 51,000 Americans are hospitalized for serious burns, and 5,500 die. Covering wounds quickly with temporary skin substitutes can help prevent infection and minimize scarring and trauma. The new Dermagraft-TC wound covering is grown in a laboratory from human cells, then frozen and packaged. To use, the surgeon unfreezes the temporary skin, then stretches it over the burn site. The surgeon removes the temporary covering when the patient's own skin is ready to be grafted, usually in 7 to 14 days. Dermagraft-TC has not been tested in pregnant women or children under age 2, or on burns from electrical or chemical causes or on the head, hands, feet, or buttocks. FDA's March 19 approval followed a recommendation from the General and Plastic Surgery Panel of the agency's Medical Devices Advisory Committee. A study of 89 burn patients treated with Dermagraft-TC showed that it covered burns as effectively as frozen cadaver skin from tissue banks. FDA's safety review focused on the risk of disease transmission because of the product's use of human cells. The cells met FDA guidelines for cell testing. The cells were tested for known disease-producing elements, such as bacteria, fungi and viruses. The final product was tested for bacteria and fungi. Some data raised the possibility of a higher risk of infection from the Dermagraft-TC. At FDA's request, the manufacturer, Advanced Tissue Sciences of La Jolla, Calif., will conduct a postmarket study of 200 patients to evaluate this risk. (For more information on skin substitutes, see "Second Skins" in the January-February 1997 FDA Consumer.) First Home Test Cleared for Blood Clotting Heart patients and others taking the blood-thinning drug Coumadin (warfarin) to prevent clotting can now test for the drug's effect at home with a prescription kit cleared by FDA. Like other blood thinners, Coumadin is used to treat people with artificial heart valves, irregular heartbeat, and other conditions that lead to excessive blood clotting. These drugs have a "narrow" therapeutic range: Too much blood thinner can cause hemorrhage, while too little can allow clots to form and obstruct blood vessels, causing stroke or death. Using the ProTime Microcoagulation System, a patient pricks a finger to draw a blood sample and runs the sample through a small, hand-held electronic device that displays results on a screen. FDA previously cleared the test, known as a prothrombin time (PT) test, for use in doctors' offices, clinics, and nursing homes to check blood coagulation. The home prescription version will be for use under a doctor's supervision. Previously, patients taking Coumadin had a PT test every one or two months during regular visits to their doctor. With the new kit, they can test themselves weekly, or as often as their doctor recommends. The system stores the 40 most recent results with a date and time stamp, enabling the doctor to review and interpret results and adjust the drug if needed. Doctors can program the appropriate upper and lower blood-clotting ranges for each patient. FDA cleared the device after reviewing data on 84 patients at four clinics. The patients had the professional laboratory PT test at the clinics and also tested themselves with the home kit. Both types of tests showed comparable results. International Technidyne Corp., Edison, N.J., makes the ProTime Microcoagulation System. Proposal to Speed New Uses For Drugs and Biologics Ways to speed development of new and supplemental uses for approved drugs and biological products using all available data to determine effectiveness are being explored by FDA under a proposed plan. FDA's "New Use Initiative--Evidence for Primary and Supplemental Approvals," proposed March 13, gives industry clear guidance on when the agency can determine effectiveness for a new use without the usual standard of two new clinical trials. In some cases, for example, FDA can rely on effectiveness information extrapolated from existing data. In others, the agency can accept evidence from a new single trial, as long as it is supported by existing related clinical data, or adequate evidence from a single study at more than one medical center. The drafts, "Guidance for Industry: FDA Approval of New Cancer Treatment Uses for Marketed Drug and Biological Products" and "Guidance for Industry: Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products" are available from FDA by calling (1-800) 835-4709 or by visiting http://www.fda.gov/cber/guidelines.htm on the agency's Web site. GRAS Substances Proposal Could Aid Food Data, Safety An FDA proposal to replace a rule-making system with a simpler process should increase food manufacturers' requests for agency affirmation that food substances are generally recognized as safe (GRAS). More requests would add to FDA's data on marketed foods. And less rule-making would free agency resources for other food-safety issues. The public can comment on the proposal, published in the April 17 Federal Register, until July 16. If a food manufacturer determines a food substance is GRAS--that is, generally recognized as safe by qualified experts--the company does not need FDA approval before marketing. However, if a manufacturer wants FDA affirmation that the substance is GRAS, the company currently must submit a petition and go through lengthy rule-making. Under FDA's proposal, a manufacturer would simply notify FDA of the GRAS determination and provide evidence to support this decision. FDA would evaluate the evidence and respond within 90 days. The proposal allows for FDA to reevaluate the notification if new information indicates a reason for concern. The proposed simpler process would give manufacturers greater incentive to inform FDA of their GRAS determinations. This, in turn, would increase FDA's awareness of ingredients in the nation's food supply and the cumulative dietary exposure to GRAS substances. FDA also could redirect resources to food ingredient safety issues that may have a greater impact on public health, such as those posed by novel proteins, carbohydrates, fats, and oils. Send written comments to the FDA Dockets Management Branch (HFA-305), 12420 Parklawn Drive, Room 1-23, Rockville, MD 20857-0001. The Federal Register is available in some public libraries, and the proposal is located at http://vm.cfsan.fda.gov/~lrd/fr970417.html on FDA's Web site. Generic Premarin Not Approvable Synthetic generic versions of the conjugated-estrogens drug Premarin will not be approved at this time, FDA has concluded. The generics are not shown to contain the same active ingredients as Premarin and, therefore, are not shown to work the same in treating menopausal symptoms and preventing osteoporosis. Because generic drug makers do not have to repeat the clinical studies used to develop the brand-name drugs, they must ensure their products are as safe and effective by showing that the active ingredients are the same and that they are bioequivalent--that is, absorbed and used by the body in the same way as the original products. Previously it was believed that two estrogens--sodium estrone sulfate and sodium equilin sulfate--were Premarin's sole active ingredients. New laboratory and clinical studies show this may not be the case. Other components in Premarin may contribute to its effectiveness. These and other findings, including a report by the agency's ad hoc working group on conjugated estrogens, underscore the lack of precise knowledge about Premarin. FDA announced May 5 that Premarin must be better characterized before its active ingredients can be definitely identified and that the bioequivalence guidance for conjugated estrogens should be reexamined. The guidance describes how to measure whether the rate and extent of absorption in the blood of a generic version are equivalent to those of Premarin. The agency encourages the start of studies that will permit scientific determination of the drug's active ingredients and provide a potential for approval of generic versions. (For information about estrogen replacement therapy, see "New Attitudes Toward Menopause" in the March 1997 FDA Consumer.) Free Reprints * Colds and Flu: Time Only Sure Cure (FDA) 97-1264 * Controlling Asthma (FDA) 97-1265 * Overcoming Infertility (FDA) 97-1269 * Sulfites Safe for Most, Dangerous for Some (FDA) 97-2308 To order single copies, write to FDA, HFE-88, Rockville, MD 20857. To order 2 to 100 copies, write to FDA, HFI-40, at the same address, or fax your order to (301) 443-9057. Include the publication number. Nearing the 5-A-Day Goal Adults' Average Daily Intake of Fruits and Vegetables 1989-91 3.9 servings 1994 4.4 servings 2000 Goal 5 to 9 servings Adults' average daily intake of fruits and vegetables is closing in on five servings, according to the U.S. Department of Agriculture's Continuing Surveys of Food Intakes by Individuals. The National Cancer Institute, which recently reported this data, and the Produce for Better Health Foundation sponsor the National 5 A Day for Better Health campaign to increase consumers' consumption of fruits and vegetables. (See "Fruits and Vegetables: Eating Your Way to 5 A Day" in the March 1997 FDA Consumer.) ------------------------------------------------------------------------ Notebook The Notebook: a potpourri of items of interest gathered from FDA news releases, other news sources, and the Federal Register (designated FR, with date of publication). The Federal Register is available in many public libraries. It is also available electronically through GPO Access at the Government Printing Office. Nicotine poisoning in children can result from exposure to nicotine patches, which may retain up to 74 percent of nicotine after use, according to a study at Harvard Medical School and several other medical centers. Symptoms of nicotine poisoning include vomiting, nausea, headaches, dizziness, and fatigue. Study authors advise parents to store new patches in a locked cabinet and to dispose of used ones right away. If a child is exposed to a patch, even briefly, remove the patch immediately, wash the skin, and call a local poison center. ("Pediatrics electronic pages," May 1997, at http://www.pediatrics.org/) AIDS deaths have declined for the first time since the epidemic began, according to the national Centers for Disease Control and Prevention. During the first six months of 1996, AIDS deaths dropped 13 percent compared with the first six months of 1995. CDC says the decline is likely due to improved treatments and prevention efforts. Overweight affects about 14 percent of children ages 6 to 11, 12 percent of adolescents ages 12 to 17, and 35 percent of adults age 20 and over, according to the third National Health and Nutrition Examination Survey (NHANES), conducted by CDC from 1988 to 1994. This represents significant increases in all age groups since the second NHANES, from 1976 to 1980. A surgeon general's report on physical activity and health is available by calling toll-free (1-888) CDC-4NRG or visiting http://www.cdc.gov/ on the World Wide Web. The USDA/DHHS "Dietary Guidelines" are available for 50 cents from the Consumer Information Center, Dept. 378-C, Pueblo, CO 81009, or can be obtained free from http://odphp.osophs.dhhs.gov/ on the Web. Whether prostate cancer will be fast- or slow-growing may be predicted by how prostate-specific antigen (PSA) behaves in a man's blood, according to researchers at the National Institute on Aging and the Johns Hopkins University School of Medicine. This information can help physicians decide which treatment--"watchful waiting," surgery, or radiation--is best for prostate cancers diagnosed in early stages. (Urology, March 1997) Patients with moderate-to-severe asthma can greatly reduce their risk of hospitalization by using inhaled steroids, especially if they also use bronchodilators, according to a study at Brigham and Women's Hospital in Boston. Researchers found a 50 percent reduced hospitalization risk in those using inhaled steroids, and a 70 percent reduced risk in those using the steroids and more than eight bronchodilator prescriptions a year. (Journal of the American Medical Association, March 19) Estrogen use may help older women avoid dry skin and wrinkling, according to research at the University of California at San Francisco involving 3,875 postmenopausal women ages 40 to 74. The researchers found a 25 to 30 percent lower incidence of skin problems associated with aging in women who used noncontraceptive estrogen. (Archives of Dermatology, March 1997) Companies using the term "healthy" on food labels will not have to adhere to earlier published standards for sodium reduction until January 2000, according to an FDA final rule. The agency postponed the standards, which were to take effect January 1998, to provide time to review issues raised in a citizen's petition, such as a lack of consumer acceptance of low-sodium foods and a lack of acceptable sodium substitutes. The agency also plans to seek additional comment on the petition. (FR April 1) Information about proper prenatal care from the Health Resources and Services Administration is now as close as your telephone. Call toll-free (1-800) 311-2229 (English), or (1-800) 504-7081 (Spanish). U.S. Department of Agriculture school meal programs can now use yogurt as a meat alternative, according to a final rule. Four ounces of yogurt can substitute for one ounce of meat in breakfast, lunch or dinner in the programs. (FR March 6) ------------------------------------------------------------------------ Investigators' Reports FDA Uncovers Contaminated Covers by John Henkel A ready-made market for medical equipment covers awaited Joseph Cottone and Bill O'Ryan when their company, American Medical Products (AMP), started marketing the devices five years ago. Because hospitals needed the covers to shroud instruments used in performing angioplasty and other catheterization procedures, business was potentially lucrative. But as FDA investigators learned, the devices sold initially were not sterile, though their packaging clearly stated they were. Typically, the manufacturer sterilizes the covers by gamma radiation before they are sold; AMP's earliest covers did not undergo this process. FDA documented that between April 10 and May 15, 1992, AMP sold about 4,440 nonsterile covers to hospitals nationwide. These covers, made of clear plastic with an elastic band around the bottom to hold them in place, are used to cover fluoroscopes and other x-ray equipment. Because they are used in a sterile surgical field with catheters, pacemakers, and other devices that actually enter the body, nonsterile covers pose potential contamination hazards to patients. For exposing patients to this risk, Cottone is now serving time in federal prison. Judge Harold Murphy, of the U.S. District Court for the Northern District of Georgia, sentenced Cottone in January to 22 months in jail and three years' probation for conspiracy and providing a false statement to FDA. According to the Department of Justice, the sentence was one of the longest ever obtained in a device prosecution. Bill O'Ryan, former financial backer of the company, testified against Cottone at a grand jury hearing and at Cottone's sentencing. O'Ryan was sentenced in January to two years' probation, including six months of home confinement. He received a reduced sentence after cooperating with authorities. The case began when Marie Mathews, an investigator in FDA's Atlanta district office, received a complaint in April 1992 from a competing cover maker. The complainant claimed to know that a Clearwater, Fla., hospital had recently bought some of AMP's covers and that the covers possibly were not sterile. The following month, Mathews followed up on the tip and visited the hospital. Officials there showed her invoices documenting the hospital's purchase of AMP medical covers labeled as "sterile." In June, Mathews, with fellow investigator Carol Selman, inspected AMP's facility in Cartersville, Ga. Cottone, whose official title at the time was operations manager, told Mathews that the company had not sold any products until May 20, and he provided invoices showing that. Cottone signed an affidavit swearing to the truth of this statement. The AMP inspection also revealed violations of good manufacturing practices (GMPs). "Among the things we found was rodent contamination that came in contact with the raw materials used to make the covers," Mathews says. The next day, the two investigators went to AMP's shipping contractor in Atlanta. Officials there verified that they had shipped AMP medical covers numerous times before May 20. Mathews went back to AMP's plant and confronted Cottone with the shipper's information. At first, she says, Cottone tried to explain the shipments by claiming that some of the covers had been sent as samples and weren't intended to be sterile. Eventually, he confessed to distributing nonsterile covers. But Cottone held back some invoices because, Mathews says, "he wanted to limit how much we knew. He was afraid he'd lose his remaining customers' business if they got a call from FDA." FDA tests of nonsterile cover samples from AMP showed the presence of molds, yeasts, and other microorganisms, all considered unacceptable in a sterile environment. Because surgeons may touch the covers with gloved hands and then touch the catheter tube that is threaded into the body for diagnostic purposes or to unblock clogged blood vessels, any contamination on the covers could be transferred to the catheter and into the patient's body. FDA urged the company to recall its covers shipped before May 19, after Mathews determined that AMP's contractor had begun sterilizing covers shipped after May 19. Cottone claimed a recall began June 17, 1992. But FDA investigators found the recall to be ineffective. Cottone told Mathews he had called his customers, but "in our checks of hospitals, virtually none had received any recall notice," Mathews says. "The recall was a disaster." On Jan. 20, 1993, the U.S. District Court for the Northern District of Georgia entered a consent decree of injunction of AMP because of the GMP infractions. The company was allowed to reopen several weeks later after it corrected the violations. On April 17, 1996, a grand jury indicted Cottone on 18 counts of violations, including sales of misbranded and adulterated medical devices and lying to a federal agent. Cottone pleaded guilty in April 1996 to two counts; the others were dismissed. His sentence was "enhanced" partly because Cottone had a previous criminal record that included drunk driving convictions. The sentencing judge also took into account other factors, such as Cottone's obstruction of justice during the investigation. This resulted in a stiffer sentence, says Mathews. Judge Murphy said Cottone had been "wanton and reckless in his risk to the patients exposed to these covers." O'Ryan, in an interview with Mathews during the investigation, said he and Cottone knew the covers were not sterile. He said selling the devices was a "bad business decision" brought about because of "hard times." The company is still in business, but it is now called MC Medical and is owned by Cottone's wife. John Henkel is a member of FDA's public affairs staff. ------------------------------------------------------------------------ Plumber's Counterfeit Drug Operation Down the Tubes A Brooklyn plumber who spent six months in prison for selling counterfeit fertility drugs continues to serve out a three-year probation. Convicted in 1995, David Braun also had to pay $725,000 to the company whose two drugs were illegally copycatted. FDA continues a multinational investigation of others who were involved in the scheme, including the man FDA's Office of Criminal Investigations suspects was the operation's "kingpin." Braun's involvement was discovered in a three-month investigation in which OCI agents gathered evidence showing that Braun ran a shell company--an answering service with a fictitious name and address that took orders for the fertility drugs Pergonal (menotropins for injection) and Metrodin (urofollitropin for injection). The evidence showed that Braun delivered fake copies of the drugs to U.S. drug wholesalers, giving them huge discounts of as much as 20 percent off the average wholesale price. The manufacturer of genuine Pergonal and Metrodin, Serono Laboratories Inc. of Norwell, Mass., contacted OCI in September 1993 to report that some unusual-looking drugs and their packaging brought to the company's attention had been tested and found to be counterfeited. Serono also told OCI they had noticed an unexpected drop in sales of Pergonal and Metrodin during the previous 18 months. FDA "hit this investigation hard," says OCI Special Agent Brian Krompasick, noting that 14 of OCI's New York agents, as well as agents from Miami, Chicago, and Washington, D.C., were involved. "For the public safety, we wanted to stop these drugs from going into the stream of commerce." While FDA knows of no injuries from the imposter drugs, the agency's concern was that the drugs could pose a danger because they were not manufactured according to FDA's safety and effectiveness standards. Also, says OCI Special Agent Stephen Haynes, "It seemed likely the case involved a sophisticated and organized network reaping millions of dollars in fraudulent profit." Braun was selling the fake fertility drugs for a wholesale price of about $380 for a one-month's supply, compared with $460 for the real Pergonal and Metrodin. To catch Braun at work, OCI got the help of a major Serono distributor who had been approached in September 1993 about buying the fakes. In September and October 1993, the distributor arranged to have more than $500,000 worth of the fertility drugs delivered. When they were delivered, OCI seized all the batches, which were later tested and found to be fakes. The distributor--or agent Krompasick posing as the distributor's accountant--was wired to record the conversations with Braun and other suspected counterfeiters during the deliveries. For additional evidence, FDA set up an undercover operation outside the distributor's warehouse on Oct. 28, 1993. While an OCI agent sat in his parked car, one of the suspected counterfeiters arrived at the warehouse and couldn't find a legal parking spot for his van. So he double-parked--right next to the agent's car. Outside the van, the suspected counterfeiters discussed the terms of the deal with the distributor. "They were almost leaning on our car," Krompasick says. "Our agent was so nervous. He's in the car--police radio and all--right under their noses." After photos taken by the OCI agent were enhanced by an FBI lab, Krompasick says, "it was undeniable that Braun and his van were at the meeting." But FDA wanted to find the source of Braun's drugs. So, as planned beforehand, when the suspected counterfeiters' delivery man brought another load of drugs to the warehouse, the cooperating distributor told him that FDA was onto the scam, and he couldn't accept the delivery. OCI agents then followed the delivery car as it left with the rejected drugs. They saw the delivery man meet Braun in Brooklyn, where the two loaded the boxes of drugs into Braun's van. "Because of the heavy traffic and dark, we made the decision to arrest Braun then and there," Krompasick says. "Braun was oblivious to the surveillance; he didn't know what hit him." While searching Braun and his van, OCI agents found his wallet with identification, as well as blank invoices with the fictitious name and address of the shell company and two metal dye stamps like those that would be used to print the fraudulent packages. "When we found those things, we knew we had one of our counterfeiters," Krompasick says. Braun pleaded guilty to conspiracy to sell misbranded drugs and was sentenced Nov. 8, 1995, in the U.S. District Court for the Eastern District of New York. In addition to prison, probation, and the money he was ordered to pay to Serono, he also had to perform 250 hours of community service. Within two weeks of Braun's arrest, Serono saw a recovery in sales. "It appears we've shut this counterfeit group down," Krompasick says. --Tamar Nordenberg ------------------------------------------------------------------------ A Trail of Tiny Turtles An anonymous tip led an FDA investigator into a Las Vegas pet store, where he witnessed and stopped the sale of illegal pet turtles to a woman with two young children. FDA analysis later showed the store's turtles--about 30 of them, which the pet store owner voluntarily handed over--carried Salmonella bacteria. In humans, Salmonella can cause fever, diarrhea, and other gastrointestinal problems; in severe infection, it can lead to other complications, even death. The laboratory finding was not unusual because turtles are well-known carriers of Salmonella. The public health risk this presents was the reason FDA banned sales of baby turtles to consumers in 1975. Young children are especially vulnerable to Salmonella infection from turtles because they like to hold the animals and then will stick their fingers--sometimes even the turtles themselves--in their own or another child's mouth. Babies also are vulnerable, usually through indirect contact from parents or siblings. Despite the dangers--and the ban--consumers continue to buy the baby turtles as pets, not only in pet stores but at flea markets and street fairs, as well, according to FDA's San Francisco district office. The turtles sell for as much as $15 each in the Las Vegas area, said Luis Chavarria, the investigator with FDA's Las Vegas resident post who intercepted the turtle sale at the pet store last October. Their appeal is strong, as Chavarria and other FDA personnel discovered. "They're incredibly cute," Chavarria said. "They're the cutest things you ever saw." FDA personnel were so taken with the turtles that they decided to videotape them for a news piece to warn consumers about the dangers of baby pet turtles. At press time in May, all but 10 of the turtles had died of natural causes, and the agency hadn't decided what to do with the others. Congress authorized FDA to regulate baby turtles in the early 1970s. At that time, 15 million baby turtles were sold yearly in the United States. Almost 5 percent of U.S. households had them as pets. And the Centers for Disease Control (now the Centers for Disease Control and Prevention) estimated that baby turtles accounted for 14 percent of Salmonella illnesses yearly in the United States. FDA's ban applies only to turtles with a shell length of 4 inches (10 centimeters) or less that are sold--or given away--to consumers. FDA allows their use for scientific, educational and exhibition purposes and for export to other countries. None of those purposes was evident when Chavarria, responding to an anonymous phone call, visited the Las Vegas pet store. He walked in to hear a pet store employee pitching the sale of turtle supplies--with the turtles thrown in as freebies--to a woman with young children. Chavarria interrupted to explain the ban on small turtles, and the woman left the store without taking any. "The employee was very upset at my disrupting her business," Chavarria recalled. "She called the store's owner right away." The owner arrived within 15 minutes, and Chavarria explained the turtle ban to him. Although he denied it initially, the owner eventually admitted that he knew the sale of baby turtles to consumers was illegal, Chavarria said. But when Chavarria told him he would have to destroy the illegal turtles, as required under federal law, the owner balked. "He said his employees wouldn't allow him to destroy the turtles," Chavarria said. "He wanted me to take them away." Without a warrant, Chavarria couldn't confiscate the turtles, so he arranged with the owner to take all the turtles for testing. The owner signed an affidavit admitting to the sale of illegal turtles and surrendered the turtles to Chavarria. Chavarria took them to his office, and, as directed by FDA's San Francisco district laboratory, planned to destroy the turtles by placing them in the freezer overnight. Typically, live samples must be destroyed before testing, and freezing is considered a humane way of destroying turtles because the cold temperatures put them into a hibernating state. Eventually, they die in their sleep. But, Chavarria recalled, when he went to put the turtles in the freezer, he couldn't do it. "They looked up at me with their little eyes. I remembered buying them at the five-and-ten store when I was a child. I couldn't put them in the freezer," he said. So Chavarria shipped the turtles live by air to the San Francisco laboratory. There, employees decided to keep the turtles alive for use in a video. To test the live turtles for Salmonella, Lorraine Humes, a microbiologist with FDA's San Francisco laboratory, put the turtles into lactose broth, a medium for testing food for Salmonella contamination. She allowed the turtles to swim in the broth for five minutes and then put them back in their aquarium. Tests of the broth showed the turtles were carrying Salmonella. FDA is offering a video of the testing to area TV stations to show consumers how seemingly safe, cute turtles can actually be dangerous. FDA is not aware of any illnesses stemming from turtles that may have been sold by the Las Vegas pet store. But, Chavarria said, "Baby turtles can create a lot of problems. So I feel good about being able to prevent at least one customer from taking turtles that, it turned out, came from a contaminated batch." --Paula Kurtzweil ------------------------------------------------------------------------ Retired Sales Rep Sentenced For Selling Rx Drug Samples A retired drug company salesman became the sixth person convicted and sentenced in an illegal money-making scheme to sell prescription drug samples to retail pharmacists and others in the Buffalo, N.Y., area. At press time in May, Edward Mikula, of Cheektowaga, N.Y., was serving seven months in federal prison for violating the Prescription Drug Marketing Act of 1988. The law bars the sale, purchase, trade, or the offer to sell, buy or trade prescription drug samples. Such practices are considered hazardous because of the risk of counterfeit, adulterated, misbranded, subpotent, or expired drugs being sold to consumers. They also constitute fraud against legitimate prescription drug sellers. Mikula, a former Wyeth-Ayerst Laboratories sales representative who retired from the company in 1987, was convicted in the U.S. District Court for the Western District of New York in July 1996 and sentenced in December. The evidence showed that between 1988 and 1993, he sold prescription drug samples of Premarin, Procardia, Inderal, Lodine, Feldene, Reglan, and others made by various companies, including Wyeth-Ayerst, Lederle Laboratories, A.H. Robins Co., and Pfizer Labs, to former business acquaintances, such as pharmacists and other pharmaceutical purchasers. "He sold anything he could get his hands on," said Raymond Kent, a compliance officer in FDA's Buffalo district office. Kent heads a team of FDA investigators that, along with FBI and Internal Revenue Service agents, is "heavily investigating" the sale of prescription drug samples in the Buffalo, N.Y., area, Kent said. Those previously convicted and sentenced include pharmacists, a dentist, a pharmaceutical salesman, and a retired hospital administrator. Mikula's role in the scheme came to light earlier in the investigation when his name was linked in documents and conversations with others. Sifting through various records and piecing together various bits of evidence, investigators learned that Mikula, according to a grand jury indictment, met "on various occasions" with a co-conspirator to buy drug samples from another co-conspirator. Mikula refused to name his co-conspirators. The indictment said Mikula and his co-conspirators sold drug samples in their original packaging or in plastic sandwich bags and other containers. The indictment cited five instances in which Mikula received cash or checks for amounts ranging from $500 to thousands of dollars for selling drug samples. But, Kent said, "We don't know how much he made in all." A previous defendant who pleaded guilty to his involvement in the Buffalo-area drug diversion scheme and who spent time in a minimum-security prison, earned an estimated $80,000 from his illegal activities. A grand jury handed down the three-count indictment against Mikula in May 1995. He pleaded guilty to all three counts July 22, 1996. Citing the "seriousness" of Mikula's offenses, his "misguided belief" that it would be unfair to cooperate with the investigation, and his apparent belief that he had "done nothing wrong," District Judge Richard Arcara sentenced Mikula to the maximum allowed under sentencing guidelines. Upon completing his prison term, Mikula, who is in his early 70s, will spend seven months under home confinement and serve one year of supervised release. He also was fined $1,000. FDA's investigation of the prescription drug diversion scheme continues. --Paula Kurtzweil ------------------------------------------------------------------------ Correction In the Investigators' Reports article "Pharmaceutical Executives Convicted" (March 1996), the jury's decision on the three counts against Kirit R. Patel was reported incorrectly. The jury found Patel not guilty on one count, but was not able to reach a verdict on the other counts. FDA Consumer magazine (July-August 1997) ------------------------------------------------------------------------ Summaries of Court Actions Summaries of Court Actions are given pursuant to Section 705 of the Federal Food, Drug, and Cosmetic Act. Summaries of Court Actions report cases involving seizure proceedings, criminal proceedings, and injunction proceedings. Seizure proceedings are civil actions taken against goods alleged to be in violation, and criminal and injunction proceedings are against firms or individuals charged to be responsible for violations. The cases generally involve foods, drugs, devices, or cosmetics alleged to be adulterated or misbranded or otherwise violative of the law when introduced into and while in interstate commerce. Summaries of Court Actions are prepared by Food and Drug Division, Office of the General Counsel, HHS, and are published by direction of the Secretary of Health and Human Services. SEIZURE ACTIONS Food/Contamination, Spoilage, Insanitary Handling PRODUCT: Rice, at Houston, Texas (S.D. Texas); Civil Action No. H-96-1425. CHARGED 5-3-96: While held for sale after shipment in interstate commerce at Captain Charlie Seafood Co., in Houston, Texas, the articles were adulterated in that they were held under insanitary conditions whereby they might have been contaminated with filth--402(a)(4). DISPOSITION: The articles were reconditioned. (F.D.C. No. 67140; S. No. 96-730-121; S.J. No. 1 PRODUCT: Rice, long grain, at Washington, D.C. (D.D.C.); Civil Action No. 1:96CV00519. CHARGED 3-15-96: While held for sale after shipment in interstate commerce at Happy Valley Food, Inc., in northeast Washington, D.C., the articles were adulterated in that they were held under insanitary conditions whereby they might have been contaminated with filth--402(a)(4). DISPOSITION: The articles were reconditioned. (F.D.C. No. 67132; S. No. 96-655-220; S.J. No. 2 PRODUCT: Shrimp, frozen, at Tampa, Fla. (M.D. Fla.); Civil Action No. 94-1131-CIV-T-17C. CHARGED 9-19-94: While held for sale after shipment in interstate commerce at Americold Cold Storage in Tampa, Fla., the articles were adulterated in that they consisted of decomposed shrimp--402(a)(3). DISPOSITION: The shrimp were reconditioned into fish bait. (F.D.C. No. 66994; S. No. 94-557-490; S.J. No. 3 PRODUCT: Vegetarian mix, at Niles, Ill. (N.D. Ill.); Civil Action No. 94C-6103. CHARGED 10-7-94: While held for sale after shipment in interstate commerce at International Golden Foods, Inc., in Niles, Ill., the articles were adulterated in that they were held under insanitary conditions whereby they might have been contaminated with filth--402(a)(4). DISPOSITION: The articles were destroyed. (F.D.C. No. 67026; S. No. 94-741-152; S.J. No. 4 Drugs/Human Use PRODUCT: Acne cream, at Wallingford, Conn. (D. Conn.); Civil Action No. 394CV00813. CHARGED 5-19-94: While held for sale after shipment in interstate commerce at Low Pharmaceuticals, Inc., in Wallingford, Conn., the articles were adulterated in that they were new drugs without an approved application--505(a). The articles were misbranded in that their labeling failed to bear the established name of each active ingredient and the directions for use--502(e) and 502(f)(1). DISPOSITION: The articles were destroyed. (F.D.C. No. 66787; S. No. 93-660-001; S.J. No. 5 PRODUCT: Various articles of drugs, at Brooklyn, N.Y. (E.D. N.Y.); Civil Action No. CV-96-1689. CHARGED 4-9-96: While held for sale after shipment in interstate commerce at Maxi International Trading Corp., in Brooklyn, N.Y., the articles were adulterated in that they were new drugs without an approved application--505(a). The articles were misbranded in that their labeling failed to bear adequate directions for use--502(f)(1). DISPOSITION: The articles were destroyed. (F.D.C. No. 67122; S. No. 95-646-441; S.J. No. 6 Medical Devices PRODUCT: Stimulator, at Akron, Ohio (N.D. Ohio); Civil Action No. 5:95CV959. CHARGED 4-28-95: While held for sale after shipment in interstate commerce at Universal Management Services, Inc., in Akron, Ohio, the article was adulterated in that it was a class III device without an application for premarket approval--501(f)(1)(B). The article was misbranded in that it was not included in a required list, and a notice or other information regarding the article was not provided as required--502(o). DISPOSITION: The article was destroyed. (F.D.C. No. 67076; S. No. 95-739-449; S.J. No. 7 Cosmetics PRODUCT: French bronze tablets, at Brooklyn, N.Y. (E.D. N.Y.); Civil Action No. CV-88-1936. CHARGED 6-18-88: While held for sale after shipment in interstate commerce at FBNH Enterprises, Inc., d/b/a French Bronze Tablets, in Brooklyn, N.Y., the articles were adulterated in that they were not hair dyes, and they contained an unsafe color additive which had no regulations in effect for its use--601(e) and 721(a). DISPOSITION: The articles were destroyed. (F.D.C. No. 65450; S. No. 88-457-959; S.J. No. 8 ------------------------------------------------------------------------ CRIMINAL ACTIONS DEFENDANT: Mark Dalen, at Clarendon Hills, Ill. (N.D. Ill.); Criminal No. 96CR0691. CHARGED 11-5-96: Count 1: The defendant introduced into interstate commerce a cosmetic that was adulterated in that it contained an unsafe additive--301(a) and 303(a)(1). DISPOSITION: The defendant was sentenced to 36 months of probation and ordered to pay a $1,000 fine. (F.D.C. No. 66512; S.J. No. 9 DEFENDANTS: International Nutrition and Gene Oden, at Las Vegas, Nev. (D. Nev.); Criminal No. CR-5-95-27-PMP (LRL). CHARGED: 2-3-95: Counts 1 to 4: The defendants introduced into interstate commerce unapproved new drugs--301(d) and 303(a)(1). DISPOSITION: International Nutrition, which was found guilty on all counts, was sentenced to five years of probation and ordered to pay a $60,000 fine. Defendant Gene Oden, who pleaded guilty to counts one and two, was sentenced to five years of probation and ordered to pay a $5,000 fine. (F.D.C. No. 66861; S.J. No. 10 DEFENDANTS: Arthur and Juanita Mallard, at Mobile, Ala. (S.D. Ala.); Criminal No. 95-00193-AH. CHARGED 2-15-96: Count 1: The defendants knowingly concealed property belonging to Arthur Mallard from the U.S. Bankruptcy Court and creditors--18 U.S.C. section 152. Counts 2 to 3: Defendant Arthur Mallard, along with others, knowingly devised a scheme to defraud and obtain money from purchasers of Mallard's beauty products--18 U.S.C. section 1341. Count 4: The defendants willfully attempted to evade the payment of federal income tax by placing funds and property in the names of nominees, by filing and causing the filing of false income tax returns, by filing and causing the filing of a false bankruptcy petition, by dealing in currency, and by other means--26 U.S.C. section 7201. Count 5: Defendant Arthur Mallard knowingly subscribed to a false federal income tax return by not reporting additional income--26 U.S.C. section 7206(1). Count 6: Defendant Arthur Mallard knowingly aided in the preparation of a fraudulent federal income tax return--26 U.S.C. section 7206(2). Counts 7 to 13: Defendant Arthur Mallard, with the intent to defraud and mislead, knowingly devised a scheme to obtain money from purchasers of over-the-counter preparations which were also unapproved new drugs introduced into interstate commerce--505(a), 301(d), and 303(a)(2). DISPOSITION: Defendant Arthur Mallard, who was found guilty on all counts, was sentenced to 11 years of imprisonment and three years of probation. He was also ordered to pay a $50,000 fine, a $650 special assessment, and $39.95 in restitution. Defendant Juanita Mallard, who was found guilty on counts 1 and 4, was sentenced to five years of imprisonment and three years of probation. She was ordered to pay a $10,000 fine and a $100 special assessment. (F.D.C. No. 66873; S.J. No. 11 DEFENDANT: Medicine Club International, Inc., at Ontario, Canada (D. Md.); Criminal No. AW-94-0373. CHARGED 9-27-94: Count 1: The defendant, with the intent to defraud and mislead, introduced into interstate commerce an unapproved new drug--301(d) and 303(a)(2). DISPOSITION: The defendant pleaded guilty and was sentenced to five years of probation and ordered to pay a $500,000 fine. (F.D.C. No. 66581; S.J. No. 12 DEFENDANT: Warner-Lambert, at Morris Plains, N.J. (D. Md.); Criminal No. DKC-95-0463. CHARGED 11-28-95: Count 1: The defendant, with the intent to defraud and mislead, failed to report information concerning the failures of distributed batches of drugs to meet stability testing specifications--301(e) and 303(a)(2). DISPOSITION: The defendant pleaded guilty and was ordered to pay a $10 million fine. An individual was also indicted on five related counts. He was found not guilty at trial on three counts, and the remaining counts were dismissed. (F.D.C. No. 66419; S.J. No. 13 ------------------------------------------------------------------------ INJUNCTION ACTIONS DEFENDANT: Charles A. Ellis d/b/a PIPA Laboratories, Inc., at Roslindale, Mass. (D. Mass.); Civil No. 93-10127 WD. CHARGED 1-22-93: The defendant introduced adulterated drugs into interstate commerce--301(a) and 301(k). The drugs were adulterated in that the methods used in, and the facilities and controls used for, its manufacture, processing, packing, and storage were not in conformity with current good manufacturing requirements--501(a)(2)(B). DISPOSITION: A consent decree of permanent injunction was filed. Subsequently, PIPA Laboratories, Inc., ceased operations. (Inj. No. 1284; S. No. 91-637-846; S.J. No. 14 DEFENDANTS: Laerdal Manufacturing Corp., and John Karpowicz, at Tualatin, Ore. (D. Ore.); Civil Action No. 93-1141-FR. CHARGED 12-1-95: The defendants introduced adulterated and misbranded devices into interstate commerce--301(a) and 301(k). The devices were adulterated in that the methods used in, or the facilities or controls used for, their manufacture, processing, packing, and storage were not in conformity with current good manufacturing requirements--501(h). The devices were misbranded in that the defendants failed to file the required medical device reporting information--502(t)(2). DISPOSITION: The district court enjoined the defendants for failing to furnish medical device reporting information. The corporate defendant filed an appeal, and the appellate court affirmed the district court's decision. Subsequently, the firm ceased operations. (Inj. No. 1326; S. No. 93-591-710/3; S.J. No. 15 DEFENDANTS: Royal Baltic Ltd., Vladamir Furleiter, and Alexander Kaganovsky, at Brooklyn, N.Y. (E.D. N.Y.); Civil Action No. CV-94-1178. CHARGED 5-15-95: The defendants introduced into interstate commerce adulterated fish--301(a) and 301(k). The fish was adulterated in that it was prepared, packed and held under insanitary conditions whereby it might have been rendered injurious to health--402(a)(4). DISPOSITION: A consent decree of permanent injunction was filed. (Inj. No. 1314; S. No. 92-647-646; S.J. No. 16 ------------------------------------------------------------------------ MISCELLANEOUS ACTIONS ACTION: Bristol-Myers Squibb Co. v. Shalala and Kessler, at Washington, D.C. (D.D.C.); Civil Action No. 1:94CV01516. CHARGED 7-13-94: The plaintiff, a pioneer drug manufacturer, challenged regulations authorizing approval of generic drugs for less than all indications approved for the pioneer product. DISPOSITION: The district court dismissed the complaint for lack of constitutional standing. The plaintiff appealed, and the appellate court reversed the lower court's decision. The appellate court held that FDA may approve a generic version of a pioneer product when the pioneer enjoys exclusivity over one or more, but not all, indications. (Misc. No. 1040; S.J. No. 17 ------------------------------------------------------------------------ ------------------------------------------------------------------------ FDA Consumer is the official magazine of the U.S. Food and Drug Administration. Each issue contains in-depth feature articles written for the general public on FDA-related health issues. 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