FDA Posting Quarterly Reports of Potential Drug Safety Issues-September 2008

The first quarterly report by the FDA of drugs that are being evaluated for potential safety issues has been posted to the FDA’s Web site. The list of drugs—identified based on a review of reports in the FDA’s Adverse Event Reporting System (AERS)—is required by Congress as part of FDA amendments signed into law last year.

The agency stresses that the appearance of a drug on this list does not mean that the FDA has concluded the drug has the listed risk, or that the FDA has identified a causal relationship between the drug and the listed risk.

“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,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research.

If a drug appears on the AERS-based quarterly report, it means that the FDA has begun an analysis to determine whether there is a safety problem. Depending on the level of analysis completed, it may be too early to know whether there is a safety problem, and the FDA’s analysis may ultimately conclude there is no safety problem, the FDA notes.

The quarterly reports will not be cumulative; they will list only drugs for which new safety information or potential signals of serious risk have been identified through AERS during the previous 3 months.

More information on the report, “Potential Signals of Serious Risks Identified by AERS,” as well as a listing of the 20 drugs identified for the period January-March 2008, can be found at

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www.fda.gov/cder/aers