Early Warnings Coming on Drug Safety

(September 7, 2008) - Instead of waiting to issue warnings about a drug's safety, the Food and Drug Administration (FDA) says it will now let people know when it starts investigating the safety of a drug. (Read about "Medicine Safety") FDA has posted on its Web site its first quarterly report that lists certain drugs that are being evaluated for potential safety issues. The drugs have been identified based on a review of reports in FDA's Adverse Event Reporting System (AERS).

The information is being provided under provisions of the FDA Amendments Act, signed into law almost a year ago. The law requires that FDA inform the public each quarter of new safety information or potential signals of serious risk, based on the agency's review of adverse event reports contained in AERS.

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.

"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, M.D., director of FDA's Center for Drug Evaluation and Research.

Drugs that appear on the agency's new AERS-based table, titled "Potential Signals of Serious Risks/New Safety Information," are identified by FDA reviewers based on reports from the FDA's AERS database, which contains millions of reports of adverse events submitted to FDA by drug manufacturers, healthcare professionals and patients. For a drug to appear on this report, an FDA reviewer will have determined there is a reason to examine a drug more closely based on either the seriousness or number of AERS reports associated with the drug. The drugs for which issues have been identified are under evaluation for the listed potential risk.

This first quarterly report, posted to FDA's Web site, lists 20 drugs along with the potential safety issue associated with each drug.