The Food and Drug Administration is taking second look this week at the heart safety of pain medications used by millions of Americans to treat arthritis and other everyday aches and pains.
The question is whether naproxen — the key ingredient in Bayer's Aleve and many other generic pain pills — carries a lower risk of heart attack and stroke than rival medications like ibuprofen, sold as Advil by Pfizer and Motrin by Johnson & Johnson, among others.
Debate about whether one drug is safer than others in the class has waged for more than a decade without a clear answer, underscoring the lingering questions that hang over even the most established medicines.
The FDA is asking its panel of medical experts to review a massive analysis published last year suggesting that naproxen does not increase the risk of heart problems as much as its peers. The finding came from Oxford University researchers who reviewed results from more than 700 NSAID studies involving roughly 350,000 patients.
On Tuesday panelists will vote on whether naproxen has a lower risk of heart problems than other NSAIDs. The FDA panel will also vote on whether over-the-counter NSAID labeling should be changed to warn patients of the short-term risks. The FDA is not required to follow the group's advice, though it often does.
Last year U.S. consumers bought more than 275 million boxes of over-the-counter NSAIDs, representing $1.7 billion in sales, according to retail tracker IRI. Prescription NSAIDs brought in billions more, led by the Pfizer's blockbuster Celebrex, with sales of $2.9 billion.
This week's FDA meeting is the latest chapter in an ongoing safety review 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.
— The Associated Press
First published February 10 2014, 2:07 PM