HICNet Medical News Digest Sun, 24 Apr 1994 Volume 07 : Issue 13 Today's Topics: [MMWR 8 April 94] Water Hemlock Poisoning [MMWR] Health-Risk Behaviors Among Persons Aged 12-21 Years [MMWR] Fatalities Associated with Harvesting of Sea Urchins [MMWR] Human Plague [MMWR] Adult Blood Lead Epidemiology and Surveillance FDA Approves Tacrolimus for Liver Transplant Patients FDA Warnings on "Sensor Pad" Tamoxifen Warning Increased Risk Cancer of the Uterus Antioxidants and Cancer Study +------------------------------------------------+ ! ! ! Health Info-Com Network ! ! Medical Newsletter ! +------------------------------------------------+ Editor: David Dodell, D.M.D. 10250 North 92nd Street, Suite 210, Scottsdale, Arizona 85258-4599 USA Telephone +1 (602) 860-1121 FAX +1 (602) 451-1165 Compilation Copyright 1994 by David Dodell, D.M.D. All rights Reserved. License is hereby granted to republish on electronic media for which no fees are charged, so long as the text of this copyright notice and license are attached intact to any and all republished portion or portions. The Health Info-Com Network Newsletter is distributed biweekly. Articles on a medical nature are welcomed. If you have an article, please contact the editor for information on how to submit it. If you are interested in joining the automated distribution system, please contact the editor. E-Mail Address: Editor: Internet: david@stat.com FidoNet = 1:114/15 Bitnet = ATW1H@ASUACAD LISTSERV = MEDNEWS@ASUACAD.BITNET (or internet: mednews@asuvm.inre.asu.edu) anonymous ftp = vm1.nodak.edu Notification List = hicn-notify-request@stat.com FAX Delivery = Contact Editor for information ---------------------------------------------------------------------- Date: Sat, 23 Apr 94 15:33:15 MST From: mednews (HICNet Medical News) To: hicnews Subject: [MMWR 8 April 94] Water Hemlock Poisoning Message-ID: <56a0kc1w165w@stat.com> Water Hemlock Poisoning -- Maine, 1992 On October 5, 1992, a 23-year-old man and his 39-year-old brother were foraging for wild ginseng in the midcoastal Maine woods. The younger man collected several plants growing in a swampy area and took three bites from the root of one plant. His brother took one bite of the same root. Within 30 minutes, the younger man vomited and began to have convulsions; they walked out of the woods, and approximately 30 minutes after the younger man became ill, they were able to telephone for emergency rescue services. Within 15 minutes of the call, emergency medical personnel arrived and found the younger man unresponsive and cyanotic with mild tachycardia, dilated pupils, and profuse salivation. Severe tonic-clonic seizures occurred and were followed by periods of apnea. He was intubated and transported to a local emergency department. Physicians performed gastric lavage and administered activated charcoal. His cardiac rhythm changed to ventricular fibrillation, and four resuscitative attempts were unsuccessful. He died approximately 3 hours after ingesting the root. Although the older brother was asymptomatic when he arrived at the emergency department, he was treated prophylactically with gastric lavage and administered activated charcoal. He began to have seizures and exhibit delirium 2 hours after eating the root; he was stabilized and transferred to a tertiary-care center for observation. No additional adverse effects were reported. The root ingested by the two brothers was identified as water hemlock (Cicuta maculata). In October 1993, postmortem samples of frozen liver tissue, blood, and gastric contents from the man were analyzed by high-pressure liquid chromatography for cicutoxin, a poisonous substance in water hemlock. Cicutoxin, a neurotoxin, was not detected; however, the toxin is labile and may have degraded during storage. Reported by: K Sweeney, MD, Office of the Chief Medical Examiner; KF Gensheimer, MD, State Epidemiologist, Maine Dept of Human Svcs; J Knowlton-Field, Damariscotta, Maine. RA Smith, Livestock Disease Diagnostic Center, Dept of Veterinary Science, Univ of Kentucky, Lexington. Health Studies Br, Div of Environmental Hazards and Health Effects, National Center for Environmental Health, CDC. Editorial Note: Based on mortality data files maintained by CDC's National Center for Health Statistics, from 1979 through 1988 (the most recent national data available) at least 58 persons in the United States died after ingesting a poisonous plant that was misidentified as an edible fruit or vegetable; inadvertent ingestion of water hemlock, as in the two cases in this report, caused at least five of these deaths. During 1989-1992, the American Association of Poison Control Centers recorded four deaths attributed to ingestion of poisonous plants (1-4). Water hemlock--also known as beaver poison, children's bane, death-of-man, poison parsnip, and false parsley--is in the same family as parsley, parsnips, celery, and carrots. It is similar in appearance to parsnips, smells like fresh turnips, and tastes sweet, but it is the most toxic indigenous plant in North America (5). Although cicutoxin is present in all parts of the water hemlock plant, the root contains the highest concentration. Ingestion of a 2-3-cm portion of the root can be fatal in adults (6), and use of toy whistles made from the water hemlock stem has been associated with deaths in children (7). The plant is poisonous at all stages of development and is most toxic in the spring. Poisonings typically result from ingestions; however, cicutoxin also may be absorbed through the skin. Mild toxicity from water hemlock produces nausea, abdominal pain, and epigastric distress within 15-90 minutes. The early gastrointestinal response of vomiting may be somewhat protective as many persons regurgitate the undigested root. Diaphoresis, flushing, and dizziness also have been reported. In severe intoxications, profuse salivation, perspiration, bronchial secretion, and respiratory distress leading to cyanosis develop soon after ingestion. In fatal poisonings, severe seizures occur after the initial symptoms, and death results usually from status epilepticus. The case-fatality rate for poisonings reported from 1900 through 1975 was 30% (8). The last fatality attributed to ingestion of water hemlock in Maine occurred in the early 1970s. No antidotes exist, and treatment is supportive. Complications associated with serious poisonings include rhabdomyolysis with renal failure (transient hematuria, glycosuria, and proteinuria), severe metabolic acidosis, bradycardia, and hypotension (9). This report underscores the need for persons who forage for edible wild plants to be aware of and able to recognize poisonous plants in their area. Water hemlock causes most of the fatalities attributed to misidentification of poisonous plants because the plant is lethal in small quantities, resembles edible plants, and is found throughout North America. Health-care providers who know that their patients eat wild plants should caution them about the potential adverse health effects. References 1. Litovitz TL, Holm KC, Clancy C, Schmitz BF, Clark LR, Oderda GM. 1992 Annual report of the American Association of Poison Control Centers National Data Collection System. Am J Emerg Med 1993;11:494-555. 2. Litovitz TL, Holm KC, Bailey KM, Schmitz BF. 1991 Annual report of the American Association of Poison Control Centers National Data Collection System. Am J Emerg Med 1992;10:452-505. 3. Litovitz TL, Bailey KM, Schmitz BF, Holm KC, Klein-Schwartz W. 1990 Annual report of the American Association of Poison Control Centers National Data Collection System. Am J Emerg Med 1991;9:461-509. 4. Litovitz TL, Schmitz BF, Bailey KM. 1989 Annual report of the American Association of Poison Control Centers National Data Collection System. Am J Emerg Med 1990;8:394-442. 5. Kingsbury JM. Poisonous plants of the United States and Canada. Englewood Cliffs, New Jersey: Prentice Hall, 1964:372. 6. Dreisbach R. Handbook of poisoning. 8th ed. Los Altos, California: Lange Medical Publications, 1974:433. 7. Miller MM. Water hemlock poisoning. JAMA 1933;101:852-3. 8. Starreveld E, Hope MB. Cicutoxin poisoning (water hemlock). Neurology 1975;25:730-4. 9. Carlton BE, Tufts E, Girard DE. Water hemlock poisoning complicated by rhabdomyolysis and renal failure. Clin Toxicol 1979;14:87-92. ------------------------------ Date: Sat, 23 Apr 94 15:34:04 MST From: mednews (HICNet Medical News) To: hicnews Subject: [MMWR] Health-Risk Behaviors Among Persons Aged 12-21 Years Message-ID: Health-Risk Behaviors Among Persons Aged 12-21 Years -- United States, 1992 Health-risk behaviors among youth may result in immediate health problems (e.g., injuries and sexually transmitted diseases) or extend into adulthood and increase risk for chronic diseases (e.g., heart disease and cancer) (1). This report uses national data from the Youth Risk Behavior Survey (YRBS), conducted as part of the 1992 National Health Interview Survey (NHIS), to examine the prevalence of selected self-reported health-risk behaviors among persons aged 12-21 years. The YRBS is a component of CDC's Youth Risk Behavior Surveillance System, which periodically measures the prevalence of priority health-risk behaviors among adolescents (1). The 1992 NHIS was conducted among a representative sample of the civilian noninstitutionalized U.S. population using a multistage cluster-area probability design of approximately 120,000 persons representing 49,000 households. The YRBS was conducted as a follow-back survey to the NHIS among a representative sample of persons aged 12-21 years in the sampled households. Adolescents who did not attend school were oversampled. During April 1992-March 1993, respondents listened to a tape recording of the questionnaire and recorded their responses on a standardized answer sheet. Questionnaires were completed by 10,645 (77.2%) eligible respondents. Respondents were categorized into three age groups that generally corresponded to three schooling levels: middle/junior high school (12-13 years; n=2195), senior high school (14-17 years; n=4126), and postsecondary school (18-21 years; n=4324). SUDAAN was used to compute all standard errors for the estimates and for differences between the estimates (2). All estimates were based on weighted data. Persons aged 12-13 years were significantly less likely than those aged 18-21 years to have reported "always" using safety belts when riding as a passenger in a car or truck (31.6% versus 36.1%) (Table 1). The percentage of persons who reported that, during the 30 days preceding the survey, they had ridden with a driver who had been drinking alcohol increased significantly with age group (12-13-year-olds, 11.3%; 14-17-year-olds, 21.7%; and 18-21-year-olds, 34.5%); in comparison, the percentage who reported physical fighting during the 12 months preceding the survey decreased significantly with age group (12-13-year-olds, 49.0%; 14-17-year-olds, 43.8%; and 18-21-year-olds, 29.4%). Adolescents aged 14-17 years were significantly more likely than those aged 12-13 years and aged 18-21 years to have reported carrying a weapon (e.g., gun, knife, or club) during the 30 days preceding the survey (17.1% versus 12.6% and 13.6%, respectively). Reported use of motorcycle helmets did not vary by age group. Lifetime and current* cigarette use increased significantly with age group, and current* use of smokeless tobacco was significantly higher among the older age groups (Table 1). Compared with persons aged 12-13 years, those aged 18-21 years were three times more likely to have reported using alcohol during their lifetimes (28.0% versus 86.7%), nine times more likely to report current episodic heavy drinking** (4.3% versus 39.7%), 13 times more likely to have used marijuana during their lifetimes (3.4% versus 45.8%), and 28 times more likely to have used cocaine during their lifetimes (0.4% versus 11.4%). Reported injecting-drug use was significantly higher among persons aged 14-17 years (0.9%) and aged 18-21 years (1.2%) than among those aged 12- 13 years (0.1%). Persons aged 18-21 years were significantly more likely to report having had sexual intercourse (81.7%) and to have had four or more sex partners during their lifetimes (41.3%) than 14-17-year-olds (43.4% and 13.3%, respectively) (Table 1).*** Among adolescents who reported having had sexual intercourse during the 3 months preceding the survey, 14-17-year-olds were significantly more likely than 18-21-year-olds to have used a condom (58.5% versus 36.9%) and significantly less likely to have used birth control pills (18.2% versus 34.8%) during last sexual intercourse. Reported consumption of five or more servings of fruits and vegetables during the day preceding the survey decreased significantly by age group (12- 13-year-olds, 17.0%; 14-17-year-olds, 13.4%; and 18-21-year-olds, 10.9%) (Table 1). Consumption of two or more servings of foods typically high in fat during the day preceding the survey was significantly less common among 18- 21-year-olds (27.7%) than among 12-13-year-olds (32.9%) or 14-17-year-olds (34.2%). Participation in moderate physical activity**** decreased significantly by age group (12-13-year-olds, 34.8%; 14-17-year-olds, 27.4%; and 18-21-year-olds, 21.2%). Reported by: Div of Adolescent and School Health, National Center for Chronic Disease Prevention and Health Promotion; Div of Health Interview Statistics, National Center for Health Statistics, CDC. Editorial Note: The findings in this report document age group comparisons of the most important health-risk behaviors among a nationally representative sample of 12-21-year-olds. These findings extend previous analyses, which documented how health-risk behaviors differ between young persons who were and were not enrolled in school (3). Public health and education officials can use these findings to target interventions to the most appropriate age groups. For example, although reported sexual activity was higher among 18-21-year-olds than among 14- 17-year-olds, condom use was lower and birth control pill use was higher among members of the older group. These findings suggest that although persons in the older group were better protected against unintended pregnancy, they were less protected against human immunodeficiency virus infection and other sexually transmitted diseases. The finding that levels of reported physical activity were inversely proportionate to age suggests the need for increased efforts to motivate adolescents to sustain at least moderate levels of physical activity throughout their lives. Based on the survey, at least one fourth of all 12-13-year-olds engage in at least one health-risk behavior (e.g., failure to always wear safety belts, physical fighting, tobacco use, or alcohol use), underscoring the importance of initiating prevention measures early--ideally during elementary school (4). However, because the prevalence of health-risk behaviors generally increases with age, such measures must be reinforced in middle/junior high school and senior high school. For example, comprehensive school health education should be provided from kindergarten through 12th grade and should focus on assisting students to develop skills to avoid or reduce the most important health-risk behaviors (4). Additional interventions that focus on skills to promote healthy behavior should be made available to young persons in the workplace and in postsecondary institutions. References 1. Kolbe LJ, Kann L, Collins J. Overview of the Youth Risk Behavior Surveillance System. Public Health Rep 1993;108(suppl):2-10. 2. Shah BV, Barnwell BG, Hunt PN, LaVange LM. SUDAAN user's manual, release 5.50. Research Triangle Park, North Carolina: Research Triangle Institute, 1991. 3. CDC. Health risk behaviors among adolescents who do and do not attend school--United States, 1992. MMWR 1994;43:129-32. 4. Public Health Service. Healthy people 2000: national health promotion and disease prevention objectives--full report, with commentary. Washington, DC: US Department of Health and Human Services, Public Health Service, 1991; DHHS publication no. (PHS)91-50212. * On 1 or more of the 30 days preceding the survey. ** Drinking five or more drinks of alcohol on at least one occasion during the 30 days preceding the survey. *** Respondents aged 12-13 years were not asked the sexual behavior questions. **** Walked or rode a bicycle at least 30 minutes at a time on 5 or more of the 7 days preceding the survey. ------------------------------ Date: Sat, 23 Apr 94 15:35:01 MST From: mednews (HICNet Medical News) To: hicnews Subject: [MMWR] Fatalities Associated with Harvesting of Sea Urchins Message-ID: <39a0kc3w165w@stat.com> Fatalities Associated with Harvesting of Sea Urchins -- Maine, 1993 During 1992-1993, six persons died while diving for sea urchins in Maine waters--two during 1992 and four during August-November 1993. The four 1993 deaths were investigated by the Maine Department of Marine Resources, the U.S. Coast Guard, the Office of the Chief Medical Examiner in Maine, and the Occupational Safety and Health Administration (OSHA); each of the deaths was attributed to drowning. This report describes the results of the investigations of these cases. Case 1. On August 19, an experienced 52-year-old diver was harvesting sea urchins from a vessel anchored in heavy fog. He exhausted his air supply after 1 hour and, while still in the water, requested another air tank from a support person (i.e., tender) in a small inflatable boat. The tender and another diver in a larger boat could not locate the diver in the reduced visibility. He was found submerged approximately 30 minutes later, and cardiopulmonary resuscitation (CPR) was unsuccessful. Case 2. On August 31, an experienced 22-year-old diver was attempting on-board repairs to his urchin-harvesting vessel, which was moored in harbor during a rainstorm. During the repairs, his skiff broke loose from the harvesting vessel and began to drift in rough waters. He drowned while swimming to recover the skiff. His body was recovered 3 weeks later. Case 3. On September 7, a 24-year-old college student, who had recently completed a basic scuba diving certification course, was attempting his first saltwater dive in fair sea and weather conditions. He was harvesting sea urchins in 30 feet of water when the tender lost sight of his bubbles within minutes of starting the dive. A diver onboard the boat and another diver in the water were not in visual contact with the distressed diver. He was found submerged approximately 20 minutes later, and CPR was unsuccessful. OSHA subsequently cited the boat owner for violations of commercial diving standards. Case 4. On November 3, a 25-year-old man with less than 2 weeks of diving experience was harvesting sea urchins in open seas with powerful surf. The diver surfaced and was attempting to untangle his catch-bag recovery line when he became caught in breaking surf along a nearby rock formation. The person in the tending vessel was unable to assist him because the vessel was too large to maneuver in shallow waters. Another diver in the water was unaware of the situation. The man was found submerged approximately 20 minutes later, and CPR was not attempted. OSHA subsequently cited the boat owner for violations of commercial diving standards. Reported by: SC Shannon, DO, Occupational Health Program, Div of Disease Control; KF Gensheimer, MD, State Epidemiologist, Div of Disease Control, Bur of Health, Maine Dept of Human Svcs; RH LeHay, Maine Dept of Marine Resources; J Ciampa, US Coast Guard Marine Safety Office, Portland. Alaska Activity, Div of Safety Research, National Institute for Occupational Safety and Health; Div of Field Epidemiology, Epidemiology Program Office, CDC. Editorial Note: The commercial fishing industry has one of the highest occupational fatality rates in the United States (1). In Alaska, during 1991 and 1992, the average annual occupational fatality rate for the fishing industry was 200 per 100,000 workers, and the fatality rate for the shellfish fishery was 530 per 100,000 (1). In comparison, during 1993 in Maine, the fatality rate for the sea urchin-harvesting industry was 278 per 100,000 workers. During 1980-1989, the average annual rate of traumatic occupational fatalities in Maine was 7.6 per 100,000 (2). Although sea urchin-harvesting vessels constitute approximately 10% of commercial fishing vessels, they account for 25% of all commercial fishing vessels lost in northern New England (U.S. Coast Guard Marine Safety Office, Portland, Maine, unpublished data, 1994). Commercial harvesting of sea urchins in Maine began in 1987, and the harvest doubled during 1992-1993, primarily because of increased demand for yellow roe. In 1993, 1439 divers were licensed to harvest sea urchins in Maine waters, and approximately 30-40 million pounds of roe were harvested. In general, sea urchins are harvested by hand by divers using scuba equipment. The most marketable sea urchins are present in the subtidal zone along rock ledges in less than 30 feet of water. The highest quality roe is harvested during the winter. Shallow water over ledges and the often adverse Maine weather require divers and vessels to operate in waters with strong currents and powerful surf. These conditions pose substantial hazards for the sea urchin industry in Maine--especially for inexperienced divers and persons unfamiliar with operating vessels in adverse sea and weather conditions (U.S. Coast Guard Marine Safety Office, Portland, Maine, unpublished data, 1994). In addition to the four deaths reported in 1993, the U.S. Coast Guard reported an estimated five incidents in which deaths were averted only after extensive search-and-rescue efforts by state and federal agencies. For example, in one incident, aircraft were used to locate a sea urchin diver who became separated from the harvesting operation. Many divers work alone, and one harvest vessel may support several divers in multiple locations along a productive ledge. Thus, divers may be unable to summon assistance from the supporting vessel or from other divers. Basic recreational scuba diving certification may not adequately train new divers for commercial activities such as sea urchin harvesting. Legislation has been introduced in Maine that would impose stricter training and certification requirements for sea urchin divers. The proposal would require persons to obtain a certificate of commercial diving competency before being issued a license to hand-harvest sea urchins. OSHA regulations require that each boat that tends sea urchin divers must have a diver stand by to provide assistance when another diver is in the water, and support personnel must be trained in CPR. In addition, each diver must be line-tended from the surface or in visual contact with another diver. Two of the cases described in this report (cases 3 and 4) prompted OSHA to apply work-safety standards for commercial diving to the sea urchin fishery for the first time by issuing citations to the owners of both boats. References 1. CDC. Commercial fishing fatalities--Alaska, 1991-1992. MMWR 1993;42:350- 1,357-9. 2. NIOSH. Fatal injuries to workers in the United States, 1980-89: a decade of surveillance. Cincinnati: US Department of Health and Human Services, Public Health Sevice, CDC, 1993. ------------------------------ Date: Sat, 23 Apr 94 15:35:36 MST From: mednews (HICNet Medical News) To: hicnews Subject: [MMWR] Human Plague Message-ID: <20a0kc4w165w@stat.com> Emerging Infectious Diseases Human Plague -- United States, 1993-1994 From 1944 through 1993, 362 cases of human plague were reported in the United States; approximately 90% of these occurred in four western states with endemic disease (Arizona, California, Colorado, and New Mexico) (1). During each successive decade of this period, the number of states reporting cases increased from three during 1944-1953 to 13 during 1984-1993 (Figure 1), indicating the spread of human plague infection eastward to areas where cases previously had not been reported. In 1993, health departments in four states reported 10 confirmed cases* of human plague to CDC; one case has been confirmed during 1994**. This report summarizes information about the 11 cases of human plague reported during 1993-1994 and describes epidemiologic and epizootic trends of plague in the United States. In 1993, the 10 confirmed cases of human plague were reported from New Mexico (six cases), Colorado (two), Texas (one), and Utah (one) (Table 1). Persons with plague infection were aged 22-96 years (median: 55.5 years); five were aged greater than or equal to 67 years. Six cases occurred among men. Five cases occurred during June-August, three during March-May, and two during September-November. Seven persons were exposed at their homesites, and one (a veterinarian) was exposed at work; exposure sites could not be determined for two cases. Seven cases were bubonic plague; two, primary septicemic; and one, primary pneumonic. Nine of the 10 patients recovered with antibiotic therapy; one patient died (Table 1). For three patients, the probable mode of transmission was flea bite (based on the presence of an inguinal bubo or a recollection of flea bites). Two patients (including the veterinarian) were infected by domestic cats with visible signs of plague infection (i.e., oral lesions and a swollen tongue). For five cases (including the fatal case), the probable mode of transmission could not be determined; however, evidence of plague infection in local animal populations was detected in association with three of these cases (Table 1). In 1994, plague infection has been confirmed in a 56-year-old resident of Inyo County, California, who had onset of illness on January 1 (the first report in California of a human plague case during winter since 1928) (Table 1). The patient lived in a county where plague was known to be endemic. In addition, he had recently worked in a subterranean gold mine and slept in a cabin at the minesite; signs of rodent activity were found in the mine shaft and the cabin outbuildings. Reported by: SB Werner, MD, R Murray, DrPH, K Reilly, DVM, M Madon, MS, M Jay, DVM, C Smith, MS, B Wilson, MS, J Wang, MS, RJ Jackson, MD, California Dept of Health Svcs; R Hurd, J Levesque, MD, Inyo County Health Dept, Independence, California. J Pape, MS, T Davis, MS, RE Hoffman, MD, State Epidemiologist, Colorado Dept of Health. R Stoneberg, Montana Dept of Fish, Wildlife, and Parks; TA Damrow, PhD, State Epidemiologist, Montana State Dept of Health and Environmental Sciences. C Montman, Albuquerque Environmental Health Dept; T Brown, MS, P Reynolds, M Tanuz, New Mexico Environment Dept; M Eidson, DVM, CM Sewell, DrPH, State Epidemiologist, New Mexico Dept of Health. S Lanser, MPH, R Tanner, MPA, CR Nichols, MPA, State Epidemiologist, Utah Dept of Health. W Kramer, Nebraska State Dept of Health. TG Murnane, DVM, BN Hicks, PV Thomas, DVM, J Buck, J Taylor, MPH, GM Moore, MS, Texas Dept of Health; J Wood, City of Dallas, C Vaughn, MS, C Haley, MD, R Farris, MD, Dallas County Health Dept, Dallas. DR Akin, P Bohan, MS, R Enscore, MS, J Sarisky, MPH, L Courtois, Office of Environmental Health, Indian Health Svc. L Handegard, MT Billings, D Virchow, NE Scottsbluff, Animal and Plant Health Inspection Svc, Animal Damage Control, US Dept of Agriculture. RJ Andrascik, Theodore Roosevelt National Park, National Park Svc, North Dakota. Div of Field Epidemiology, Epidemiology Program Office; Bacterial Zoonoses Br, Div of Vector-Borne Infectious Diseases, National Center for Infectious Diseases, CDC. Editorial Note: The findings in this report emphasize the increasing importance of two related trends in the epidemiology of human plague in the United States: 1) increased peridomestic transmission and 2) the role of domestic cats as sources of human infection. Peridomestic transmission is especially important in the most highly plague-endemic states of Arizona, Colorado, and New Mexico, where rapid suburbanization has resulted in increasing numbers of persons living in or near active plague foci. Domestic cats that are permitted to roam freely in areas where plague occurs in rodents are at increased risk for infection and, therefore, increase the risk for peridomestic transmission to humans. Before 1977, domestic cats were not reported as sources of human plague infection; however, since 1977, cats have been identified as the source of infection for 15 human plague cases. In addition, the proportion of human plague cases with primary pneumonic plague has been substantially higher among cat-associated cases (four of 15 cases) than among cases for which cats were not sources of infection (one of 236 cases). Persons working in veterinary practices should be warned of the risks associated with handling plague-infected cats. Four of the 15 cat-associated cases occurred in veterinarians or their assistants. In addition, CDC recommends that veterinary personnel wear gloves and eye protection and take appropriate respiratory precautions (2) when examining sick cats in or from plague-endemic areas, especially cats with lymphadenopathy, oral lesions, or pneumonia. Surveillance for plague in rodent and rodent-consuming carnivore populations during the 1990s indicates that plague has spread eastward to counties in areas (e.g., eastern Montana, western Nebraska, western North Dakota, and eastern Texas) believed to be free of this disease since widespread animal surveillance began in the 1930s (3-5). For example, the potential for human plague cases in eastern Texas was demonstrated in 1993 when an infected roof rat (Rattus rattus) and two infected fox squirrels (Sciurus niger) were identified in Dallas. Animal surveillance was initiated in the Dallas metropolitan area to monitor plague in local rodent and carnivore populations as a sentinel of increased risk for plague among humans. The continued expansion of human plague in the United States (Figure 1) underscores the need to enhance plague surveillance and to increase efforts to prevent, detect, and control human plague. Epizootic plague activity usually peaks during or immediately after years with cooler temperatures and more rain than usual. Such conditions occurred during 1991-1993 in the highly plague-endemic areas of Arizona, Colorado, and New Mexico, as well as in the western Great Plains region,*** and resulted in large populations of many plague-susceptible rodent species-- including deer mice, the principal reservoir of hantavirus in the western United States (6). Nearly all fatal plague cases in the United States result from delays in seeking treatment and in making the proper diagnosis. The person with fatal plague in 1993 received medical care 6 days after onset of illness and died within 4-6 hours of seeking care at a hospital. Because of similarities in clinical features of plague and the recently discovered hantavirus pulmonary syndrome (HPS) (7), diagnosis of plague may be further complicated. In 1993, HPS was suspected in a person with secondary pneumonic plague; as a result, the patient was transported to a regional medical center in another state for specialized care. At this facility, plague was diagnosed, and the patient recovered with antibiotic treatment. Increasing public and physician awareness about plague can assist in prompt diagnosis and treatment. Efforts to prevent plague should include public education about risk factors for exposure, methods to prevent plague, and the signs and symptoms of infection; surveillance of rodent populations; and use of insecticides, and occasionally rodenticides, to control populations of fleas and rodents, respectively. Control measures should be undertaken when surveillance indicates epizootic activity among rodent populations. References 1. Craven RB, Maupin GO, Beard ML, Quan TJ, Barnes AM. Reported cases of human plague infections in the United States, 1970-1991. J Med Entomol 1993;30:758-61. 2. CDC. Draft guidelines for preventing the transmission of tuberculosis in health-care facilities, 2nd edition; notice of comment period. Federal Register 1993;58:52843-54. 3. Eskey CR, Haas VH. Plague in the western part of the United States. Public Health Bulletin 1940;254. 4. Caten JL, Kartman L. Human plague in the United States, 1900-1966. JAMA 1968;205:81-4. 5. Barnes AM. Surveillance and control of bubonic plague in the United States. In: Edwards MA, McDonnel U, eds. Animal disease in relation to conservation. New York: Academy Press, 1982:237-70. 6. CDC. Hantavirus infection--southwestern United States: interim recommendations for risk reduction. MMWR 1993;42(no. RR-11). 7. CDC. Update: outbreak of hantavirus infection--southwestern United States, 1993. MMWR 1993;42:495-6. * A case of human plague is considered to be confirmed when 1) a bacterial culture is identified as Yersinia pestis by biochemical testing and bacteriophage typing or 2) there is a fourfold rise in antibody titers to the F-1 antigen of Y. pestis. ** Provisional data. *** West North Central, West South Central, and Mountain regions. ------------------------------ Date: Sat, 23 Apr 94 15:36:32 MST From: mednews (HICNet Medical News) To: hicnews Subject: [MMWR] Adult Blood Lead Epidemiology and Surveillance Message-ID: Current Trends Adult Blood Lead Epidemiology and Surveillance -- United States, Fourth Quarter, 1993 CDC's National Institute for Occupational Safety and Health (NIOSH) Adult Blood Lead Epidemiology and Surveillance (ABLES) program monitors elevated blood lead levels (BLLs) in adults. Blood lead data from laboratory reports are transmitted to state-based lead surveillance programs and are compiled by NIOSH for quarterly reporting (1). Data for 1993 from the 20 states currently reporting results to NIOSH are complete (Table 1). Efforts to expand the number of states participating in the surveillance system continue as states increase their capacity to monitor BLLs in both adults and children. Reported by: NH Chowdhury, MBBS, Alabama Dept of Public Health. C Fowler, MS, Arizona Dept of Health Svcs. FJ Mycroft, PhD, Occupational Health Br, California Dept of Health Svcs. BC Jung, MPH, Connecticut Dept of Public Health and Addiction Svcs. M Lehnherr, Occupational Disease Registry, Div of Epidemiologic Studies, Illinois Dept of Public Health. R Gergely, Iowa Dept of Public Health. E Keyvan-Larijani, MD, Lead Poisoning Prevention Program, Maryland Dept of the Environment. R Rabin, MSPH, Div of Occupational Hygiene, Massachusetts Dept of Labor and Industries. A Carr, MBA, Bur of Child and Family Svcs, Michigan Dept of Public Health. D Solet, PhD, Div of Public Health Svcs, New Hampshire State Dept of Health and Human Svcs. B Gerwel, MD, Occupational Disease Prevention Project, New Jersey State Dept of Health. R Stone, PhD, New York State Dept of Health. M Barnett, MS, State Health Div, Oregon Dept of Human Resources. J Gostin, MS, Occupational Health Program, Div of Environmental Health, Pennsylvania Dept of Health. R Marino, MD, Div of Health Hazard Evaluations, South Carolina Dept of Health and Environmental Control. DM Perrotta, PhD, Environmental Epidemiologist, Texas Dept of Health. D Beaudoin, MD, Bur of Epidemiology, Utah Dept of Health. L Toof, Div of Epidemiology and Health Promotion, Vermont Dept of Health. J Kaufman, MD, Washington State Dept of Labor and Industries. D Higgins, Wisconsin Dept of Health and Social Svcs. Div of Surveillance, Hazard Evaluations, and Field Studies, National Institute for Occupational Safety and Health, CDC. Reference 1. CDC. Surveillance of elevated blood lead levels among adults--United States, 1992. MMWR 1992;41:285-8. ------------------------------ Date: Sat, 23 Apr 94 15:38:21 MST From: mednews (HICNet Medical News) To: hicnews Subject: FDA Approves Tacrolimus for Liver Transplant Patients Message-ID: FDA APPROVES TACROLIMUS FOR LIVER TRANSPLANT PATIENTS ===================================================== FDA is receiving inquiries about its April 8, 1994, approval of the drug tacrolimus (FK-506) for preventing graft rejection in liver transplant patients. The following may be used to answer questions. Tacrolimus is the third immunosuppressant drug to receive FDA approval for use in organ transplants. Reports from early clinical trials had suggested that it might be safer and better tolerated than the two older transplant drugs--cyclosporine, used for heart, liver and kidney transplants, and azathioprine, approved only for kidney transplants. On Nov. 22, 1993, an FDA advisory committee agreed unanimously that later clinical trials have not shown tacrolimus to be safer or more effective than cyclosporine-based treatments. However, the committee recommended approval of tacrolimus because it would provide another alternative for preventing rejection of transplanted livers. These conclusions were based on two multicenter clinical trials, each with more than 500 patients, that compared tacrolimus- and cyclosporine-based treatments for liver transplants. One study was conducted in the United States and the other in Europe. In both trials, patient and graft survival rates were very similar for the tacrolimus and cyclosporine groups. Although adverse effects were somewhat different for the two drugs, both were associated with neurological problems (headaches, insomnia, tremors), metabolic disturbances (high blood sugar), kidney disorders, high blood pressure, nausea and vomiting. These problems, which occur early in treatment, tend to subside with time. In the tacrolimus/cyclosporine clinical trials, 75 to 88 percent of patients were still alive one year after surgery. Nationally, the one-year survival rate for all first-time liver transplant patients is about 75 percent. Approximately 3,000 liver transplants are performed annually in the United States. Tacrolimus is manufactured by Fujisawa USA of Deerfield, Ill., and will be sold under the name Prograf. ------------------------------ Date: Sat, 23 Apr 94 15:39:03 MST From: mednews (HICNet Medical News) To: hicnews Subject: FDA Warnings on "Sensor Pad" Message-ID: ========================================================================= Food And Drug Administration Recalls, News, And Warnings ========================================================================= SENSOR PAD ========== FDA is receiving inquiries about Sensor Pad, a thin plastic pad filled with liquid silicone designed to aid in breast self examination. This product is not currently approved as safe and effective by FDA. The agency has informed the manufacturer, Inventive Products Inc. of Decatur, Ill., that it must conduct clinical studies on the product's safety and effectiveness and obtain pre- market approval from FDA in order to legally market it. FDA is requiring the firm to conduct clinical trials because the agency has not seen valid scientific evidence that the product will actually help women detect lumps and aid in the detection of breast cancer. FDA is concerned that rather than aid in detection, the product might actually miss lumps or mask their presence. Detection of lumps has important health implications for American women. If a product making this claim does not perform as intended, women who depend on it are put at grave risk. Inventive Products submitted a pre-market notification (510k) for Sensor Pad in 1985, saying the device was substantially equivalent to a legally marketed product. Upon review, FDA concluded that the device and its use were different from other devices. The firm was told that it would need to submit a full premarket approval application (PMA). Despite the denial of its application, in 1987 the firm began illegally marketing Sensor Pad to hospitals. This led to a series of seizures of the product by FDA. When the firm contested the original seizure, a federal court ruled in favor of FDA, concluding that the pad was an adulterated medical device. The firm appealed the ruling, contending that the product was not a medical device. In 1991, a federal appeals court affirmed the original ruling that the pad was a medical device and that an approved PMA would be required before the device could be marketed. Following the initial seizure and throughout the legal process, the firm continued to distribute the device, and FDA continued to seize it. In 1989, following the initial seizure, the firm submitted a PMA to the agency. This application contained little information and it was inadequate as a basis for determining safety and effectiveness. FDA has been working with Inventive Products for the past nine years to assist in its attempt to bring its product to market. The agency is continuing to work with the firm to help it identify what is necessary to show the product is safe and effective. FDA has met numerous times with the manufacturer to discuss the type and quality of data that are needed and the ways clinical trials can be conducted so as to be the least burdensome on the firm yet still provide the necessary information on safety and effectiveness. ------------------------------ Date: Sat, 23 Apr 94 15:39:52 MST From: mednews (HICNet Medical News) To: hicnews Subject: Tamoxifen Warning Increased Risk Cancer of the Uterus Message-ID: <6gB0kc9w165w@stat.com> TAMOXIFEN WARNING INCREASED RISK OF CANCER OF THE UTERUS ====================================== The Food and Drug Administration announced today a stronger warning to women and doctors that tamoxifen, an anti-cancer drug used in treatment of breast cancer, poses an increased risk of cancer of the uterus. Despite the increased risks, however, the latest study results have reaffirmed that tamoxifen can delay or prevent relapse in patients who have undergone surgery for breast cancer. Therefore, tamoxifen continues to be indicated for the treatment of breast cancer. The updated warning is based on the drug's package insert that has been revised to reflect the most recent data from large randomized trials. The manufacturer of tamoxifen, Zeneca Pharmaceuticals, is sending the updated labeling information in a "Dear Doctor" letter to 380,000 oncologists and health care professionals. "Tamoxifen is a valuable treatment for breast cancer, but it is important for women to recognize that there are side effects including an increased risk of cancer of the uterus," said FDA Commissioner David A. Kessler, M.D. "Women must also be advised that if they have used the drug, they need to get regular gynecologic exams and report to their doctor any abnormal vaginal bleeding or discharge." A study in Sweden, which has now followed participants for about nine years, showed that breast cancer patients who take tamoxifen have a higher risk of uterine cancer than had been suggested on the basis of earlier research. In the latest results of this study, 23 of the 1,372 patients randomized to take tamoxifen developed the disease, compared with 4 of the 1,357 patients in the control group. The ongoing B-14 trial of the National Surgical Adjuvant Breast and Bowel Project produced similar results after 6.8 years of follow-up. These data taken together show that women taking tamoxifen face a risk of uterine cancer about two to three times higher than the risk for women without breast cancer in the general population. Additional studies are under way to more clearly define the role of other risk factors, such as prior hormone use. Recent unpublished data suggest a possible increase in cancers in the gastrointestinal tract among women receiving tamoxifen. These results are at odds with other trials, and the potential risk is being evaluated. In addition, animal studies continue to support long-held concerns that use of tamoxifen in pregnancy might cause fetal harm, and raised the possibility of causing DES-like syndrome. The FDA-revised package insert and the manufacturer's letter to the health care professionals provide information on the new findings and suggest steps that should be taken by women who are using or have used tamoxifen. FDA has also taken steps to ensure that the new findings are reflected in the informed consent document for women participating in NCI-sponsored studies using tamoxifen, and that all women taking tamoxifen for treatment are informed about updated risk information. The NCI emphasizes that the benefits of tamoxifen as a treatment for breast cancer far outweigh the potential risks of other cancers. NCI's current clinical trial to study tamoxifen as a preventive agent is based on evidence that the drug reduces the risk of a new cancer in the other breast. Data also suggest that tamoxifen may decrease cardiovascular disease and stabilize postmenopausal bone loss. NCI emphasizes, however, that tamoxifen should not be used as a preventive agent outside of a clinical trial. Tamoxifen is marketed under the trade name Nolvadex by Zeneca Pharmaceuticals, Wilmington, Del. ------------------------------ Date: Sat, 23 Apr 94 15:40:37 MST From: mednews (HICNet Medical News) To: hicnews Subject: Antioxidants and Cancer Study Message-ID: ANTIOXIDANTS AND CANCER STUDY ============================= FDA has been receiving inquiries concerning a Finnish study on whether certain antioxidant vitamins protect against lung cancer. In the study, conducted jointly by the U.S. National Cancer Institute and the National Public Health Institute of Finland, vitamin E and beta-carotene supplements, when taken by male smokers age 49 and older, did not protect against lung cancer. Incidence of certain other cancers was also examined. This study is important because it is the largest controlled study of antioxidant vitamins and cancer to date. It is also the first study of this type in a well-nourished population. The following may be used to respond to questions: This study, published in the April 14, 1994, issue of the New England Journal of Medicine, evaluated effects of the use of beta-carotene and vitamin E dietary supplements on cancer. The study was designed to investigate whether the ingestion of higher levels of antioxidant-containing vitamins can reduce the incidence of lung cancer among smokers. A secondary objective of the study was to determine the effects of the supplements on the incidence of other cancers. Illnesses and deaths due to causes unrelated to cancer, such as heart disease and strokes, were also monitored. Some evidence of a role for antioxidants in prevention of cancer -- particularly lung cancer -- has been accruing from animal studies and human observational studies. However, there have been no controlled, prospective trials in humans with normal diets to evaluate the benefits and risks of antioxidants. The Finnish study, because it is a large and well-designed randomized trial, provides a better chance of being able to identify a genuine beneficial effect of antioxidant vitamins on incidence of cancer. The study was conducted over the course of approximately six years in Finland and involved more than 29,000 male smokers above the age of 49 years. This was a double-blind, placebo-controlled trial. Patients received either 50 mg of vitamin E (50 I.U. of vitamin E as alpha-tocopherol -- more than three times the Recommended Dietary Allowance), 20 mg of beta- carotene (about 33,000 I.U. or more than three times the RDA for vitamin A, the active form of beta-carotene), both vitamin E and beta-carotene, or neither (a placebo). The primary conclusion of this study is that there was no evidence of a beneficial effect of supplemental vitamin E or beta-carotene in prevention of lung cancer over the six years of the trial. Rather, the group consuming the beta-carotene had a significantly higher (18 percent) incidence of lung cancer than those participants who did not take it. Participants who took beta-carotene also had higher rates of cancers of the prostate and stomach. The overall death rate was 8 percent higher in beta-carotene supplement users than in the placebo group. Overall mortality did not significantly differ for vitamin E users and nonusers. Vitamin E was associated with a lower rate of prostate cancer and perhaps colorectal cancer, but was associated with increased risk of bladder, stomach and other cancers. While vitamin E was also associated with decreased deaths from heart disease and related strokes, it was associated with increased deaths from hemorrhagic strokes. While FDA believes this study is important and its results significant, it does not settle the antioxidant question. Confirmation in other studies is important to clarify the results. So far, data do not allow a determination of whether the results would apply to non-smokers, women and younger people. Nevertheless, FDA agrees with the study's authors that the results "raise the possibility that these substances may have harmful as well as beneficial effects. Longer observation of the participants in this trial and data from other studies of people at normal risk or high risk for cancer will be required to determine the full spectrum of effects of these agents." The results of the Finnish trial are consistent with FDA's health claim policy for foods rich in antioxidant-containing vitamins. FDA shares the view in the New England Journal of Medicine's editorial, which accompanies the study report, that many issues need to be resolved before the agency could authorize specific health claims for supplements (as opposed to diets) containing beta-carotene and vitamin E. While the study did not show that the tested supplemental beta-carotene and vitamin E were beneficial, baseline diets rich in foods containing these nutrients were predictive of lower lung cancer risk. FDA has authorized a health claim linking reduced cancer risk with consumption of low fat diets rich in fruits and vegetables that are sources of beta-carotene and vitamin E but has not authorized a health claim for beta-carotene or vitamin E in supplement form. This conclusion was based on the available data and significant scientific agreement among qualified experts that diets rich in fruits and vegetables are associated with decreased cancer risk. The agency did not find sufficient scientific agreement to attribute the effect to specific substances -- such as beta-carotene and vitamin E -- in these foods. Recommendations in the U.S. Dietary Guidelines and NCI's "Five-a-Day" program, which emphasize low fat diets rich in fruits and vegetables, remain sound advice for consumers wishing to reduce their risk of cancers and chronic diseases. FDA continues to believe that the majority of vitamin and mineral supplements consumed today -- particularly multivitamin/multi-mineral products containing nutrients at levels consistent with recommended daily amounts -- do not raise safety concerns. FDA also agrees with the conclusions of the New England Journal of Medicine's editorial: "The results of the Finnish trial do not disprove the potential benefits of antioxidant vitamins, but they do provide timely support for heightened skepticism ...". ------------------------------ End of HICNet Medical News Digest V07 Issue #13 *********************************************** --- Editor, HICNet Medical Newsletter Internet: david@stat.com FAX: +1 (602) 451-1165 Bitnet : ATW1H@ASUACAD -------------------------------------------------------------------------------