FDA To Post Quarterly Report Of Potential Safety Issues

Main Category: Regulatory Affairs / Drug Approvals
Article Date: 10 Sep 2008 - 1:00 PDT

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The U.S. Food and Drug Administration announced that it 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 Food and Drug Administration Amendments Act, signed into law Sept. 27, 2007. 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, health care 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 today, lists 20 drugs along with the potential safety issue associated with each drug. Each quarter, a new report will be posted to FDA's Web site listing additional drugs for which new safety information or potential signals of serious risks have been identified through AERS. The quarterly reports will not be cumulative; they will list only drugs for which new safety information or potential signals of serious risks have been identified through AERS during the previous quarter.

A new quarterly report listing additional drugs for which new safety information or potential signals of serious risks have been identified through AERS will be posted to the FDA's Web site every three months.

"Over the past two years, FDA has become much more proactive in our communication about possible safety problems," Woodcock said. "Patients and health care professionals have told us that they want to be informed about possible safety problems sooner. They want to know when FDA is in the early stages of looking into a potential safety problem. Congress took note of this when it directed us to post this quarterly report of potential safety issues."

Related links:

Web posting, "Potential Signals of Serious Risks/New Safety Information"
Fact sheet

U.S. Food and Drug Administration