Packaging / cGMPs

FDA Panel Votes Against Naproxen Heart Safety Claim

Feb 12, 2014


An FDA advisory panel said on Tuesday, in a 16-9 vote, that available evidence does not prove that the painkiller naproxen carries a lower cardiac risk than rival products.

The panel was convened after multiple clinical trials had suggested that naproxen (the key ingredient in Bayer's Aleve) did not carry the same heart risks as other NSAIDs, such as ibuprofen and Pfizer's Celebrex. A positive vote would have meant a marketing advantage in terms of labeling for Bayer and other naproxen drugmakers.

According to Reuters, the panel recommended the FDA leave the current product labeling as is, at least pending the outcome of a large ongoing study, known as Precision, that compares naproxen with ibuprofen and Celebrex.

Read the Reuters press release