US FDA posts first quarterly report of potential safety issues, cites eight drugs

Under the provisions of the Food and Drug Administration Amendments Act, signed into law September 27, 2007, the US Food and Drug Administration 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 the FDA's Adverse Event Reporting System.

The law requires that the FDA informs 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 2007 legislation is a result of criticism of the agency over its handling of the risks associated with US drug major Merck & Co's Vioxx (rofecoxib), as well as the potential for suicidality in children with prescription antidepressants.

Actual risks not identified