Aleve safety affirmed by FDA panel

When Vioxx was recalled in September 2004, almost all drugs in the Cox-2 inhibitor drugs category came under scrutiny. Then came a series of studies on Celebrex and Bextra that highlighted some of the risks of these drugs, causing even more confusion. As readers may recall, a FDA panel has recently recommended that Vioxx sales may resume with a black-box warning and Pfizer allowed to keep both Celebrex and Bextra on the market, though with black-box warning on Celebrex (Bextra already carries a black-box warning). (Related article: Making sense of FDA panel recommendations on Vioxx, Celebrex, and Bextra)

Another drug that got caught in the confusion is naproxen (marketed as Aleve in the United States). Other common brand name is Naprosyn. In a study by the National Institute of Health and FDA, it was found that Aleve was responsible for an apparent increase in heart problems. While the FDA issued an advisory at that time, it was primarily a precautionary step.

During the discussions held last week, Arthritis and Drug Safety and Risk Management Advisory Committees clarified conflicting reports about the safety of Aleve that have confused and, in some instances, alarmed consumers and healthcare professionals. The discussion at the Meeting of the Advisory Committees affirmed the safety of Aleve and distinguished the safety profile of naproxen, the active ingredient in Aleve, from selective COX-2 inhibitors and other non-selective nonsteroidal anti-inflammatory drugs (NSAIDs), based on the weight of clinical data presented at the meeting. Some members of the panel even suggested that naproxen should be the standard by which future pain relievers should be measured for cardiovascular safety. (Related article: Analysis of FDA panel's recommendations with regards to Vioxx, Celebrex, and Bextra)

The presentations and discussions before the Committees also clarified that the widely publicized suspension of the Alzheimer’s Disease Anti-Inflammatory Prevention Trial (ADAPT) on December 20, 2004 was precipitated not by Aleve safety concerns, but rather by administrative and practical issues.

Recommended article: European drug regulators ban, limit Cox-2 drugs