FDA Panel Votes Against Heart-Safety Claim For Pain Reliever

SILVER SPRING, Md. (February 11, 2014) New research is not strong enough to conclude that naproxen, the pain reliever in Aleve and many other medications, is safer for the heart than rival drugs used by millions of Americans to treat aches and pains, an expert U.S. Food and Drug Administration panel said Tuesday.

The FDA advisory panel voted 16-9 against the conclusion that naproxen has a lower risk of heart attack and stroke compared with similar anti-inflammatory medications like ibuprofen, sold as Advil and in other generic formulations.

Debate about whether one drug in the class is safer than others has waged for more than a decade without a clear answer.

The FDA convened the meeting this week to consider new analyses that apparently show lower heart risks for naproxen, but the panelists said the data were not conclusive.

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