Feds to Post Potential Safety Issues

Sep 10, 2008
By Pharmaceutical Executive Editors

FDA last week announced that it would publicly post a quarterly listing of drugs that are being tracked for potential safety concerns, as required by the Food and Drug Administration Amendments Act of 2007.

The first round, published on Friday, lists 20 drugs including Lilly’s Cymbalta (which is being followed for urinary retention), Biogen Idec’s Tysabri (skin melanomas), Purdue’s Oxycontin (drug abuse, misuse, and overdose), and heparin (anaphyliactic reactions). Side effects listed run the gamut from dosing confusion to Cardiac arrest and includes a number of overdose warnings.

While Congress required the listing in an effort to improve transparency, it is unclear just how useful it will be to physicians or patients. The list’s introduction, for example, explains: “The appearance of a drug on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but does not mean that FDA has identified a causal relationship between the drug and the listed risk.”

And what does that mean? Elsewhere on the FDA site, the agency explains that staffers track the Adverse Event Reporting System for possible safety signals. When a new one is first detected for a given drug—possibly by a single AER—it is entered into the CDER or CBER’s Safety Tracking System. When that happens, the potential side effect appears on that quarter’s list. Previously known adverse events (that is, virtually any safety risk that has been definitively identified as being caused by the drug) are not included.

What are patients to make of this? It’s fairly clear what FDA thinks patients will make of it: In a release, Janet Woodcock, director of CDER, stated, "My message to patients is this: Don't stop taking your medicine. If your doctor has prescribed a drug that appears on this list, you should continue taking it unless your doctor advises you differently.”

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