MARYLAND – A majority of federal health experts 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 American 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-powdered prescription drugs like Celebrex, marketed Pfizer to treat arthritis. Labeling across all the drugs warns that they can increase the risk of heart attack and other life-threatening cardiovascular events. But the 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 napraxen, a majority of panelists said the evidence was not conclusive and did not warrant changing the drug’s label.
Panelists who voted in favor of naxproxen’s safety conceded that the evidence is not definitive, but also cited a ”duty to inform the pubic.”
The findings that favored naproxen came from Oxford University researchers who combined results from more than 700 NSAID studies and found fewer heart problems with the over-the-counter and prescription naproxen. But most panelists said those results were difficult to interpret. Known as meta-analysis, the process involved combining safety data from roughly 350,000 patients across hundreds of unrelated studies.
2/12/14, The Associated Press
Source: 2/12/14 edition of the Ocala Star Banner (pg 9A)
Photo: Google Photos
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