FDA revisits heart risks with NSAIDs

FDA Advisers Revisit Heart Risks Posed by NSAIDs
FDA Advisers Revisit Heart Risks Posed by NSAIDs

HealthDay News -- Naproxen seems safer for the heart than other nonsteroidal anti-inflammatory drugs (NSAIDs), U.S. health officials say. And it's possible that labeling will soon reflect that finding.

Two FDA advisory committees are meeting Monday and Tuesday to discuss cardiac risks associated with NSAIDs. Since 2005, labeling laws have required a heart warning on NSAIDs, stemming from the withdrawal of rofecoxib (Vioxx, Merck) from the market in 2004 because of a notable increased risk of heart attack among users.

But naproxen doesn't seem to carry the same risks as the other NSAIDs, an FDA panel recently concluded after a safety review involving 350,000 people using different pain relievers. The panel posted its findings online last week.

Multiple studies -- including a meta-analysis in BMJ, a meta-analysis in PLOS Medicine and the more recent meta-analysis in The Lancet -- have found that naproxen carries a lower cardiovascular risk compared with other drugs in the class.

"To reduce the population burden of drug-related deaths from NSAID toxicity, naproxen should be considered first-line treatment in patients for whom the risk of cardiovascular adverse events is relevant," the FDA panel wrote in a review of the evidence. "Accordingly, the class NSAID labeling should be amended to reflect the more favorable cardiovascular risk profile of naproxen. The labeling can also note that naproxen had a less favorable gastrointestinal risk, but that GI events were less likely to be fatal than cardiovascular events."

If the FDA does approve a labeling change, that could make Aleve and other naproxen-containing drugs the preferred drug for patients who have a risk of heart problems, Ira Loss, a pharmaceutical analyst with Washington Analysis, told the Associated Press. However, all NSAIDs will still need to warn of risks for internal bleeding and ulceration.

The FDA advisory committees will discuss all of these issues and vote on whether the evidence supports a lower cardiovascular risk for naproxen compared with other NSAIDs, as well as whether advice regarding the lack of risk with short-term use should be modified. Although the FDA is not required to follow its advisory panel's recommendations, it frequently does.

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