FDA: Aleve may be safer on heart than rival drugs

WASHINGTON – Federal health officials say the pain reliever in Aleve may be safer on the heart than other popular anti-inflammatory drugs taken by millions of Americans.

A Food and Drug Administration review posted online Tuesday states that naproxen – the key ingredient in Aleve and dozens of other generic pain pills – may have a lower risk of heart attack and stroke than rival medications like ibuprofen, sold as Advil and Motrin. FDA staffers recommend relabeling naproxen to emphasize its safety.

The FDA safety review was prompted by a huge analysis published last year that looked at 350,000 patients taking various pain relievers. The findings suggest naproxen does not carry the same heart risks as other medications in the class known as nonsteroidal anti-inflammatory drugs, or NSAIDs.

The agency released its memo ahead of a public meeting next month where outside experts will discuss the new data and whether naproxen should be relabeled. The agency is not required to follow the group’s advice, though it often does.

If ultimately implemented, the labeling changes could reshape the multibillion-dollar market for drugs used to treat headaches, muscle pain and arthritis.

The FDA meeting is the latest chapter in an ongoing safety review of NSAIDs that stretches back to 2004, when Merck & Co Inc. pulled its blockbuster pain reliever Vioxx off the market due to links to heart attack and stroke. Vioxx was part of a subset of newer NSAIDs designed to be easier on the stomach.