FDA Advisers Revisit Heart Risks Posed by Painkillers

Studies suggest naproxen (Aleve) may pose less of a threat

By HealthDay staff

Monday, February 10, 2014

Related MedlinePlus Page

Pain Relievers

MONDAY, Feb. 10, 2014 (HealthDay News) -- Naproxen -- the key pain reliever in Aleve -- seems safer for the heart than other popular anti-inflammatory drugs such as ibuprofen (Advil and Motrin), U.S. health officials say.

And it's possible that labeling will soon reflect that finding.

Advisers to the U.S. Food and Drug Administration are meeting Monday and Tuesday to discuss cardiac risks associated with non-steroidal anti-inflammatory drugs, sometimes called NSAIDs.

Millions of people take these medicines, which also include the prescription drug Celebrex, to relieve muscle aches, headaches and pain from arthritis and injuries.

Since 2005, labeling laws have required a heart warning on these anti-inflammatory drugs. That stemmed from Merck's withdrawal of the NSAID Vioxx from the market in 2004 because of a notable increased risk of heart attack among Vioxx 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.

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, Loss said.

The FDA isn't required to follow its advisory panel's recommendations, but it frequently does.

Aspirin, another type of NSAID, isn't a focus of this week's hearings.

"The question of whether naproxen, the key ingredient in Aleve and other generic pain pills, has a lower risk of heart attack and stroke than medications, such as Advil, that contain ibuprofen, is an interesting debate," said Victoria Richards, an assistant professor of medical sciences at the Frank H. Netter MD School of Medicine at Quinnipiac University in Connecticut.

"All NSAIDS (non-steroidal anti-inflammatory drugs) come with black box warnings indicating cardiovascular and gastrointestinal risks," Richards added in a news release. "Although both ibuprofen and naproxen belong to the same class of NSAIDS, research suggests that naproxen has a significantly lower risk of cardiovascular events than ibuprofen, although the dose of ibuprofen may be taken into consideration. This lower risk might be seen with low-dose ibuprofen."

SOURCES: Feb. 10, 2014, news release, U.S. Food and Drug Administration; Victoria Richards, Ph.D., assistant professor of medical sciences, the Frank H. Netter MD School of Medicine at Quinnipiac University, North Haven, Conn.; Associated Press

HealthDay