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FDA announced that the agency has posted on its website a report listing drugs that are being investigated for potential safety concerns.
FDA announced that the agency has posted on its website a report listing drugs that are being investigated for potential safety concerns. This listing is in response to the FDA Amendments Act (FDAAA), which was signed into law in September 2007.
According to the FDAAA, the agency is required to inform patients quarterly of new safety information or potential signals of serious risks culled from the agency’s Adverse Event Reporting System (AERS), which contains reports of adverse events from drug manufacturers, healthcare professionals, and patients. A drug will be listed in this quarterly report if warranted by the severity of the adverse event or the number of adverse event reports received.
The appearance of a drug on this list means that the agency has identified a potential safety issue for the drug; it does not imply that FDA has identified a causal relationship between the drug and the risk.
A new quarterly report will be posted on the agency’s website every 3 months. The current report is available at http://www.fda.gov/cder/aers/potential_signals/potential_signals_2008Q1.htm#list.