Federal health officials say the pain reliever in Aleve may be safer on the heart than other popular anti-inflammatory drugs taken by millions of Americans.
A Food and Drug Administration review posted online Tuesday said naproxen -- the key ingredient in Aleve and dozens of other generic pain pills -- may have a lower risk of heart attack and stroke than rival medications like ibuprofen, sold as Advil and Motrin. FDA staffers recommend relabeling naproxen to emphasize its safety.
The safety review was prompted by a huge analysis published last year that looked at 350,000 patients taking various pain relievers. The findings suggest naproxen does not carry the same heart risks as other medications in the class known as nonsteroidal anti-inflammatory drugs, or NSAIDs.
The agency released its memo ahead of a public meeting next month where outside experts will discuss the new data and whether naproxen should be relabeled. The agency is not required to follow the group's advice, though it often does.
If ultimately implemented, the labeling changes could reshape the multibillion-dollar market for drugs used to treat headaches, muscle pain and arthritis.
The change could make Aleve and other naproxen drugs the first choice for patients with a higher risk for heart problems, according to Ira Loss, a pharmaceutical analyst with Washington Analysis. But he added that all NSAIDs will continue to carry warnings about internal bleeding and ulceration, a serious side effect that is blamed for more than 200,000 hospital visits every year.
The FDA meeting is the latest chapter in an ongoing safety review of NSAIDs 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. Vioxx was part of a subset of newer NSAIDs designed to be easier on the stomach. But in the wake of the Vioxx recall, the FDA beefed up warnings about heart safety risks on all drugs in the class, including Motrin, Advil, Aleve and Celebrex. Pfizer's Celebrex is the only drug from the same class as Vioxx that remains on the market.
Current labeling warns that taking NSAIDs long-term can increase the risk of heart attack and stroke. Patients and doctors are advised to take the drugs for the shortest time period possible.
But FDA staffers said in Tuesday's memo that labeling should be changed "to reflect the more favorable cardiovascular risk profile of naproxen."
Bayer spokesman Chris Loder said in a statement that naproxen's safety and efficacy is "based on clinical trials, observational studies and clinical and real world use for more than 38 years." The German-based conglomerate is one of a half-dozen pharmaceutical manufacturers presenting at the FDA meeting, scheduled for Feb. 10 and 11.
The FDA also disclosed Tuesday that it is considering halting a long-term study comparing the safety of naproxen, ibuprofen and Celebrex, the prescription painkiller from Pfizer.
Given that recent data show a lower rate of heart attack and stroke for naproxen, FDA staffers say patients in the trial are being "exposed to an undue risk."
Launched in 2006 by Pfizer, which makes both Celebrex and Advil, the PRECISION study is expected to be completed by late 2015. The company said in a statement that "current evidence does not support" changes to the labeling of its drugs.
Celebrex was New York-based Pfizer's fourth-best-selling drug last year, with sales of $2.92 billion.