FDA to post quarterly report of potential safety issues
The US FDA has posted on its website its first quarterly report listing 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 US FDA has posted on its website its first quarterly report listing 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, which requires the FDA to inform the public each quarter of new safety information or potential signals of serious risk.
The appearance of a drug on the list does not mean that the FDA has concluded that the drug has the listed risk, or that it 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.
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. 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.