FDA Posts Quarterly Reports Of Potential Drug Safety Issues

February 11, 2009 at 2:00 pm Leave a comment

The U.S. Food and Drug Administration has posted two new quarterly reports listing the drugs that are under evaluation for potential safety issues. The latest reports cover the second quarter (April-June 2008) and the third quarter (July-September 2008). In addition, the FDA is updating an earlier report on the first quarter (January-March 2008).

This posting is the latest in a series of quarterly reports describing new safety information or potential signals of serious risks based on a review of reports submitted to FDA’s Adverse Event Reporting System (AERS). The AERS database contains millions of reports of adverse events submitted to FDA by drug manufacturers, health care professionals and patients.

The FDA Amendments Act of 2007 directed the FDA to conduct regular, bi-weekly, screening of the AERS database and to provide new drug safety information to the public on a quarterly basis.

The FDA has not concluded that the drugs listed actually have the reported risks and has not identified a causal relationship between the drug and the listed risk. Drug products are only on the list because FDA has identified a potential safety issue.

The reports are available here.

More information on the FDAAA can be found here.


[Via http://www.medicalnewstoday.com]


Entry filed under: Uncategorized.

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