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June 2012
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Panel votes down heart safety claim for drug naproxen

SILVER SPRING, Md. - A majority of federal health specialists said Tuesday that new research is not strong enough to conclude that naproxen, the pain reliever in Aleve and many other medications, is safer on the heart than rival drugs used by millions of Americans to treat arthritis and everyday aches and pains.

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

The drugs, known as non-steroidal anti-inflammatory drugs or NSAIDs, include over-the-counter medications like Aleve and Motrin as well as more high-powered prescription drugs like Celebrex, marketed by Pfizer to treat arthritis. Uniform labeling across all the drugs warns that they can increase the risk of heart attack and other life-threatening cardiovascular events. But debate over whether one drug in the class is actually safer than others has waged for more than a decade without a clear answer.

The FDA convened a two-day meeting this week to review the latest evidence, including a massive analysis published last year suggesting naproxen does not increase the risk of heart problems as much as its peers. Despite an apparent "drift" toward fewer heart problems with naproxen, a majority of panelists said the evidence was not conclusive and did not warrant changing the drug's label.

"If I were forced to bet on what the truth is, my bet would be that naproxen is somewhat safer," said panelist Dr. Susan Ellenberg of the University of Pennsylvania. "On the other hand, I'm not sure how that relates to our regulatory standard, as there's still a lot of uncertainty here."

Panelists who voted in favor of naproxen's safety conceded that the evidence is not definitive, but also cited a "duty to inform the public."

"I'm convinced enough to change my own use of NSAIDs to naproxen - and that of my patients - based on what I've heard these last two days," said panelist Dr. Peter Kaboli of the University of Iowa.

The findings favoring naproxen came from Oxford University researchers who combined results from more than 700 NSAID studies and found fewer heart problems with over-the-counter and prescription naproxen. But most panelists said those results were difficult to interpret.

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