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FDA to List Drugs Being Investigated

Posted Sep 09 2008 2:05am
As first reported in the Washington Post, the FDA is now going to report quarterly on drugs that they are looking into. The report which will be published online is the result of a new law requiring the agency to reveal drugs under safety review each quarter.

I am in favor of the public and physicians knowing about medications that can be potentially concerning. However, as I have mentioned previously, posting information without data to back it up has potential dangers as well. The FDA will mention the name of the drug and the nature of the "adverse events" but they will not describe the seriousness of the problem or the number of complaints received for which the investigation was initiated. The problem is that with the 24/7 news cycle, and the media waiting for the next Vioxx, once a drug gets on the list, the public's reaction will generally be that the drug is dangerous. According to the FDA:

"The appearance of a drug on this list does not mean that FDA has concluded that the drug has the listed risk, or that FDA has identified a causal relationship between the drug and the listed risk. It is on the list only because FDA has identified a potential safety issue."

However, this has not been my experience. In fact, we evaluated our practice's diabetic patients and many of them stopped Avandia without even discussing this with their physician. There are risks and benefits to every drug, and the FDA ought to be extremely vigilant in following up any complaint they deem worth investigating. However, posting these publicly may lead patients to stop taking medications that even if the adverse event turned out to be true would still be outweighed by the benefit of the medication. The public has the right to know, but the public has the right to know all of the information. In my opinion, the FDA should post all of the information or nothing at all.
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