FDA Panel Votes Against Naproxen's Cardiovascular Safety Claim

A US Food and Drug Administration (FDA) advisory panel has not found enough clinical evidence to conclude that naproxen presents a lower risk of cardiovascular (CV) thrombotic events than other nonsteroidal anti-inflammatory drugs (NSAIDs).

Despite an FDA review that suggested naproxen does not pose the same stroke and heart attack risks as other available NSAIDs, the Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee voted 16-9 against changing naproxen’s warning label to include its CV safety claim.

The panelists also discussed whether changes should be made to nonprescription NSAID labels in order to refine their current information on CV risk; however, no consensus was reached due to an absence of sufficient clinical data