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Medical Forum / Diseases and Disorders / Diabetes / May 2007FDA: Actos and Avandia both associated with heart failure
http://www.sciencedaily.com/upi/index.php?feed=Science&article=UPI-1-20070523-22 152900-bc-us-avandia-analysis.xml "In the memo, FDA reviewers analyzed 47 cases of heart failure requiring hospitalization -- 22 occurred in patients taking Actos and 25 in those taking Avandia. "Data from this case series provides evidence that (thiazolidinediones, the class of drugs that includes Actos and Avandia) may be associated with (congestive heart failure) to an extent not clearly defined in the product labels," the reviewers concluded. They go on to note that the cases do not show conclusively the drugs caused the heart failure, but they say labeling should mention the condition has occurred in diabetic patients taking the medications. Although Avandia's labeling mentions the risk of heart failure has been detected in clinical studies, Wolfe said the FDA failed to heed the advice of its reviewers and require the listing of the postmarketing reports -- which now number 415." Susan >x-no-archive: yes > [quoted text clipped - 19 lines] > >Susan I love the word conclusively. We have had quite a few years of notes on a certain family of drugs, Read the staff changes at the FDA when Resulin was sudddenly removed from the market. The real problem is so many benefit from these drugs and we seem to be unable to develop new safer drugs. What I question is the misrepresentastion of the safety of several drugs. You need to read the transcript of the Vioxx trail in Texas. Allegedly the company rep were trained to aviod the issues when seeing the docs. I take at least one dangerous drug but the problems are known and I elect to use it. The medical profession and related areas used to be noted for honssty and very ethical behavior. That is the whole issue. Does the advantages of a drug justify it's use?. It should never be related to potential market. Key people should be held resposible for any deliberate misbehavior. Just like the mean kid down the street that steals a few bucks.. >>x-no-archive: yes >>http://www.sciencedaily.com/upi/index.php?feed=Science&article=UPI-1-20070523-22 152900-bc-us-avandia-analysis.xml >>"In the memo, FDA reviewers analyzed 47 cases of heart failure requiring >>hospitalization -- 22 occurred in patients taking Actos and 25 in those >>taking Avandia. >>"Data from this case series provides evidence that (thiazolidinediones, >>the class of drugs that includes Actos and Avandia) may be associated >>with (congestive heart failure) to an extent not clearly defined in the >>product labels," the reviewers concluded. >>They go on to note that the cases do not show conclusively the drugs >>caused the heart failure, but they say labeling should mention the >>condition has occurred in diabetic patients taking the medications. This is always a problem in ascribing causes. I have read that these drugs tend to cause edema, and this may be the culprit. >>Although Avandia's labeling mentions the risk of heart failure has been >>detected in clinical studies, Wolfe said the FDA failed to heed the >>advice of its reviewers and require the listing of the postmarketing >>reports -- which now number 415." List all 415 reports in detail? How do you get that on the label or even on the package insert? >I love the word conclusively. We have had quite a few years of >notes on a certain family of drugs, Read the staff changes at the FDA >when Resulin was sudddenly removed from the market. Rezulin would not have been removed if Actos and Avandia, which do not have the liver failure problem associated with Rezulin, were not coming out. Liver failure is the most common side effect of drugs, and in the case of Rezulin, it clearly occurred in a very SMALL proportion of users. I have not seen anything on whether Rezulin increases the chances of edema, or otherwise was associated with heart failure. There are so many causes of congestive heart failure that it would be almost impossible to assign the cause in any particular case. >The real problem is so many benefit from these drugs and we seem to be >unable to develop new safer drugs. If you know how to do it, let the biochemists know. They are trying to reduce the number of promising drugs which have so many side effects that they do not even make it through the trials. I have not seen the figures, but what proportion of those taking thiazolidinediones show these symptoms in the first 3, 5, 10 years of usage? An increased rate is hard to detect, as distinct from a clear cause. Can one detect "unsafe" drugs without having to do so much testing that the costs are prohibitive? It is these costs which make prices so high; they run into the hundreds of millions for drugs which make it to the point of marketing. >What I question is the misrepresentastion of the safety of several >drugs. You need to read the transcript of the Vioxx trail in Texas. >Allegedly the company rep were trained to aviod the issues >when seeing the docs. Even here, the evidence was not that clear. >I take at least one dangerous drug but the problems are known >and I elect to use it. >The medical profession and related areas used to be noted for honssty >and very ethical behavior. That is the whole issue. >Does the advantages of a drug justify it's use?. It should never >be related to potential market. Key people should be held >resposible for any deliberate misbehavior. Just like >the mean kid down the street that steals a few bucks.. Full disclosure should be required, including updates, but the risk-benefit balance should be decided by the INFORMED individual, not the FDA or the medical profession. This would permit shorter test periods, but with many more risks. >----== Posted via Newsfeeds.Com - Unlimited-Unrestricted-Secure Usenet News==---- >http://www.newsfeeds.com The #1 Newsgroup Service in the World! 120,000+ Newsgroups >----= East and West-Coast Server Farms - Total Privacy via Encryption =----  SignatureThis address is for information only. I do not claim that these views are those of the Statistics Department or of Purdue University. Herman Rubin, Department of Statistics, Purdue University hrubin@stat.purdue.edu Phone: (765)494-6054 FAX: (765)494-0558 >x-no-archive: yes > [quoted text clipped - 19 lines] > >Susan This is unfortunately a classic state of affairs with new drugs. What surprises me is that people continue to be surprised by the unpleasant surprises. You take a drug, and ifyou are lucky, in the phase III trials, you run up 20,000 patient years of experience. If something bad happens about once in every 20,000 patient years, there is only about a 65% chance you'll see it. If the principal investigator does see something, he will try like hell to find a reason to exclude that patient from the trial on the basis of a real or imagined exclusionary criteria. You now take that drug with 10,000 patient years experienced (and that is huge clinical trial even by current standards), and hand it out to several million patients, so you are now collecting say 10,000,000 patients years per annum. The same bad things that occured at perhaps 1 per 20,000 patient years, now can reach out and do serious damage to 500 patients per year. That is basically the problem with this class of drugs (and a few others as well). Low risk events suddently become visible when applied against tens of millions of cases. |
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