FDA Panel Deems Naproxen No Better On Heart Risks

February 12, 2014

Advisers to the FDA yesterday declined to recommend changes in the labeling for naproxen based on suggestions that the over-the-counter painkiller may pose less cardiovascular risk than other NSAIDs.

Advisers to the FDA yesterday declined to recommend changes in the labeling for naproxen based on suggestions that the over-the-counter painkiller may pose less cardiovascular risk than other NSAIDs.

The panel voted 16-9 against revising the label, stating that the evidence about cardiovascular risk is not conclusive. It opted to revisit the issue after the completion of the PRECISION trial, an ongoing prospective study comparing naproxen against other NSAIDs with respect to cardiovascular outcomes.