GENERIC DRUGS FOR ADD Generic drugs can offer substantial cost savings for ADDers, but reports of their effectiveness vary significantly, and none of the literal seems to state authoritatively why this should be. The following is a transcript of messages on this subject between members of the ADD Forum on CompuServe, including Several people who've bought both the brand name medication (e.g. Ritalin or Dexedrine) and generics (methylphenidate) and a real specialist in the field, a psychopharmacologist. This document may be copied and distributed freely without modification. It is not, however, medical advice, which can only be given by a physician who's familiar with a specific individual's case. Have you heard of any problems with generic Ritalin? I think I saw a thread on the forum not too long ago in which people were expressing concern about generic Ritalin (methylphenidate). I have no personal experience of patients reporting problems. At one time, the pharmacy where I _USED_ to get my son's prescriptions filled substituted generic Ritalin for brand name; the substitution was immediately noticable, and so, I always stree that I want brand name when his precription is refilled. Also, they have increasingly had problems in filling his prescription, telling me that their suppier is "holding back" on the Ritalin. I mentioned this to the neurologist the other day and he gave me a look as if to say, "What are they talking about?" I go to another pharmacy to fill a prescription that I use that is not easily obtainable, and they have reassured me that, to date, they do not have problems getting the medication and, since my son will be away at school next year, they will fill the prescription, and send it directly to my son. Sometime, I guess, you just have to find the right pharmacy, once everything else is in place! Glad to hear you found a pharmacy that would give you the straight scoop. I remember hearing your tales of getting obstacles from the first one. To briefly recap the thread on the generic of Ritalin: - Some people find it works fine, others don't - Some say "increase the dosage 20% because it's weaker" - Everyone seems to agree that one should get stabilized on the brand name stuff first, because it's got known potency, then try the generic and see what happens. I'm on the east coast, but there aren't too many manufacturers of Dexedrine, so I'll comment from personal experience. My wife and I have always insisted on name-brand quality for our son's dexedrine. We are convinced we saw inconsistent dosages on the rare occasions that he got generic drugs. Sometimes he zombied, sometimes he came off the drug with a crash. Fortunately for us, our medical plan is limits our co-pay to $12 for name-brand drugs. It's $6 for generic, but $6 more is worth it for consistency. Yes, there is a difference in the generic. It does NOT work as well. Also, It's better to take it more often than using the sustained release kind. There definitely doesn't seem to be a concensus on this issue. I know there may not be a definitive one way or the other, but I hoped to get a majority on one side or the other. I will continue to experiment. I got the 20mg generic this time. But I was taking 2 10mg of the "real" so I don't think this is a fair comparison due to disolving times and the like. I will get the "real" next time. The pharmicist told me he sells 80% generic and for what it is worth, he said he never heard any problems or differences. The physician said he has only heard of a few problems such as shorter duration or fluctuating effectiveness, and he wasn't sure whether it was due to concerns from patients or the drug. Can you relay your experience in more detail? I have no idea why the name brand is better, unless there are fewer quality control checks for generic makers. I would think that most children using Ritalin do not have the maturity to speak up about the difference. I am taking three 10 mg a day. I don't take them unless I know I will need them. I have had no problems with Ritalin, but I would rather use Dexedrine because the dosage is about half and it's CHEAPER! There are those who say that for them it does work as well; I guess different folks respond differently. To those working with generic drugs. I couldn't help but to notice this thread. Just to let you know about a couple of things I have been reading about currently. In the field of generic drugs there are different companies that make the same drug all across the country. So some of it can be because of the area you live, that and the fact that the standards set for controlling generic drugs are considered weak at best. In this field there are very few on the site inspection of where the drugs are made. All the drug company has to do is turn in a couple of bottles for testing. Also from what I have been reading the drugs can vary upwards of 20% - 30% of the strength of the name brand drug. In one book it said the standard was 50%. So you can get a generic lot of drug that is 20% weaker than the name brand and then go acrosse the street to another drug store and get a generic that is only 10% weaker. It all varies on the company that makes the generic drug and what there standards are. There have been several groups out there pushing for better standards amoung the drug companies that make generic. However these groups keep running up against drug companies that put up millions of $$$ to keep the standards right where they are now. Do you happen to recall the name of the book that discussed standards for generics? My impression, from previous conversations with docs here, is that a generic must have the same mix of active ingredients, no question about that. (Correct me, you knowers out there!) The variation can come in how well the active ingredients make it into your system. For instance, some mentioned seeing generic pills that were crumbling right in the bottle, which gives good reason to think they wouldn't have consistent potency. And the mixture of inert ingredients could affect how well it gets absorbed into the system. But then, recently, someone (don't remember who) said "The FDA has been much more on top of the generics recently, making sure they actually work like the brand names." Current federal regs require equivalence within 20% of the innovator's product, either way. Bioequivalence is defined basically as the area of the time vs serum concentration curve. On a graph on which the vertical axis is serum concentration of the drug and the horizontal axis is time, points are plotted and connected until drug can no longer be detected. A generic is considered "bioequivalent" as long as the area under the curve (AUC) is 80%-120% of the product originally marketed. If this seems to be a large range, I agree, unfortunately. To make matters worse, the shape of the curve doesn't have to be the same. This means that a high peak concentration with a shorter duration can have the same AUC and still be considered bioequivalent. If the generic product causes problems with toxicity, however, then it would have to be reformulated, in theory. My opinion, however, is that generic manufacturers are much less closely supervised by the FDA than the larger research centered companies. So, problems may exist for quite a while before regulatory action is actually taken. In spite of the above, I do want to say that I think there are many more "good" generics out there than bad. The advice of stabilizing on the brand name and then trying the generic should be gospel here, as far as I'm concerned. The 20% rule is correct. The generic manufacturer is required to comply with what are known as good manufacturing practices as well. The generics don't have to be within 20% of each other, but do have to be within 20% of the innovator's product. That means one generic could be 80% of the original and another could be 120%. Both meet the 20% rule, but the two generics are more than 20% different. This is why people shouldn't switch frequently from one generic to another. Another point I probably should make is that once the drug reaches systemic circulation, rates of metabolism are the same regardless of source of delivery. There are a few exceptions to this, but very few. Side effects and therapeutic effect differences among generic drugs have more to do with rate of release/absorption. If drug is released too fast, higher peak levels will be achieved, thus potentially more side effects for a while, but more drug is available for metabolism, so duration of effect is shorter. If drug is released too slowly, sufficiently high levels may not be achieved in order to maintain a therapeutic effect, but enough may float around to cause side effects for a relatively long while. This is especially important with antibiotics. Again, if a product causes significant toxicity, the gov't is supposed to step in, but this is usually very slow to occur. I should have realized that once the stuff's in the blood, it metabolizes at the same rate regardless of where it came from. Sorta like booze, right? Once you've got 1ml of ethanol in your blood, it'll take a certain amount of time to clear out, no matter how it got there; same with meds, generic or not. Right? So then the questions would become: - out of a given dose, how much "active ingredient" actually gets into the blood, and how fast? In other words, what does the start of the curve look like? - is the start of the curve steep enough to "jump-start" the response? (I mention this because some doc said he gives 5mg of regular Ritalin along with the SR, or else it never seems to "kick in", so I speculate the same might happen with a slow-delivery generic?) With most drugs, however, the amount of drug metabolized per unit time is expressed as a *percentage*. It takes the same amount of time to eliminate, say 50%, of drug on board no matter how much is present. So, once the drug gets in, the same amount of time is needed to get it out. If the drug is absorbed very slowly, it takes longer to get rid of all the dose taken than if it is absorbed rapidly only because delivery of the drug to the site of metabolism is delayed. 2. Re how much "active ingredient" actually gets into the blood and how fast: The upslope of the blood level vs time curve may vary somewhat from generic to generic of the same drug. The whole idea of a "generic equivalent" is that the drug "behaves" the same as the innovator's product. Variation in absorption *rate* can yield the same total amount of drug available, but a different clinical profile. Too much difference in *extent* of absorption, on the other hand, would be much more likely to make the drug fall outside of legally acceptable limits; i.e., 80%-120%, as well as different therapeutic effects. 3. Re "jump starting" the effect with rapid absorption, if you can do it with Ritalin, you should be able to do with a truly equivalent generic methylphenidate. A generic which is more slowly absorbed would be less likely to have such an effect. Since we don't clearly understand how Ritalin (for instance) works in the first place, nor exactly what ADD is for various people, it really does come down to that same principle: if a generic works for an individual, fine, but if it doesn't, it's no huge surprise. Another generic might, or might not. Two final questions (anyone out there, feel free to answer): 1. how much less expensive are the generics, roughly? Half, or not that big a difference? 2. Given that different generics behave differently, the next question is, is each generic at least consistent? Or will the same "brand" of generic be consistent from month to month, year to year?