FDA panel says data does not support lower heart risk of naproxen

An advisory panel to the U.S. Food and Drug Administration said on Tuesday that available evidence does not prove that the painkiller naproxen, sold under the brand names Aleve and Naprosyn, carries a lower cardiac risk than rival products. The panel was convened after a retrospective analysis from multiple clinical trials published last year in The Lancet suggested naproxen was less dangerous to the heart than other nonsteroidal anti-inflammatory drugs, or NSAIDs, such as ibuprofen and Celebrex. Panelists 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. The FDA is not bound to follow the advice of its advisory panels, but typically does so.