FDA Panel Votes Down Heart Safety Claim for Naproxen
SILVER SPRING, Md. (AP) — A majority of federal health experts say 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 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 compared with similar anti-inflammatory medications like ibuprofen, sold as Advil and in other generic formulations.
FDA is not required to follow the advice of its expert panels, though it often does.
Debate about whether one drug in the class is safer than others has waged for more than a decade without a clear answer.
NSAID drugs include over-the-counter medications like Aleve and Motrin as well as more high-dose prescription pain relievers like Celebrex, marketed by Pfizer to treat arthritis. Labeling on all the drugs warns that they can increase the risk of heart attack and other life-threatening cardiovascular events.
The FDA convened a two-day meeting this week to review the latest evidence, including a massive analysis published last year suggesting that naproxen does not increase the risk of heart problems as much as its peers. Despite an apparent "drift" toward fewer heart problems in naproxen patients, 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 advantage conceded that the evidence was 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 Dr. Peter Kaboli of the University of Iowa.