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FDA To Post List Of Drugs With Safety Issues
By Pharmalot
September 05, 2008
In keeping with its new mandate to pay closer attention to safety, the agency will be compiling a quarterly table of drugs that have been identified as having some kind of potential safety issue. The move is actually in response to a requirement in the FDA Amendments Act and the first table, to be posted on the agency web site, includes 20 different drugs identified in this year’s first quarter.
The list includes Cymbalta, Tykerb, Heparin, Revlimid, Tysabri, OxyContin, Dilantin and Seroquel. Take a look for yourself.
“We’ll be informing the public of certain drugs that are being evaluated for potential safety issues based on certain issues that come into the FDA reporting system,” known as AERS, or adverse events reporting system, Gerald Del Pan, director of the Office of Surveillance and Epidemiology in the FDA’s Center for Drug Evaluation and Research, told journalists in a briefing this morning. Here’s a fact sheet.
The litmus test for making the list includes serious news about a drug; a greater than expected number of adverse events; some new type of adverse event not previously known about or associated with a drug, and something already known that requires a “little further refinement” of FDA knowledge.
However, Del Pan stressed that the list will not be a comprehensive recital of all drugs with post-marketing safety issues that the FDA is working on. Paul Seligman, associate director of safety policy and communication, added that the review work conducted by the FDA isn’t new, but the effort to alert the public at such an early stage hasn’t been undertaken previously.
How pharma and its investors react to this will be interesting. For months, execs have complained the FDA’s focus on safety, which they maintain has resulted in more delays in approvals and outright rejections. By highlighting drugs already on the market, but not previously identified as problematic, is likely to cause still more consternation. Not every drug on the first list, for instance, has previously been the subject of a public health advisory or some other FDA communication.
