FDA Advisory Panel: Naproxen Labels Should Not Include CV Safety Claim

After reviewing current evidence on the cardiovascular safety of naproxen, the U.S. Food and Drug Administration's (FDA) Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee decided that warning labels should not be changed to include claims that the drug is associated with a lower risk of cardiovascular thrombotic events than other nonsteroidal anti-inflammatory drugs (NSAIDs). While 16 panelists voted against including cardiovascular safety claims on the label, nine members found the data to be sufficient for making the claim and several noted that they may change their personal prescribing habits as a result of the review. The FDA will have the final say.

Keywords: Advisory Committees, Anti-Inflammatory Agents, Non-Steroidal, Cardiovascular Diseases, Naproxen, Risk, Safety, United States Food and Drug Administration

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