The U.S. Food and Drug Administration announced Friday that it has posted on its website its first quarterly report that lists certain drugs that are being evaluated for potential safety issues.
The appearance of a drug on this list does not mean that the FDA has concluded that the drug has the listed risk, or that the 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," said FDA in a statement.
"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, director of FDA's Center for Drug Evaluation and Research.
The drugs have been identified based on a review of reports in FDA's Adverse Event Reporting System (AERS), which contains millions of reports of adverse events submitted to the FDA by drug manufacturers, health care professionals and patients.
Under provisions of the Food and Drug Administration Amendments Act, signed into law Sept. 27, 2007, the FDA was required to inform the public each quarter of new safety information or potential signals of serious risk.
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 lists 20 drugs along with the potential safety issue associated with each drug. Each quarter, a new report will be posted to FDA's website listing additional drugs for which new safety information or potential signals of serious risks have been identified through AERS.
Source: Xinhua
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