June 10th, 2010
09:06 AM ET
By Elizabeth Landau
Common pain medications are associated with higher risks of heart-related death in healthy people, a Danish study finds.
The research, published in the journal Circulation: Cardiovascular Quality and Outcomes, a journal of the American Heart Association, is the first to report on specific cardiovascular risks among healthy people.
Study authors looked at the use of nonsteroidal anti-inflammatory drugs (NSAIDs) in Denmark, based on records of more than 1 million healthy people over age 10 from 1997 to 2005. About 45 percent of people in the study took NSAIDs at least once over that time period, and those who did usually took the drug in low doses for about two weeks.
They found that ibuprofen - the main ingredient in Advil and Motrin - was associated with a 29 percent greater risk of fatal or nonfatal stroke, compared with people who did not take a prescription NSAID.
Diclofenac, marketed under various brand names including Voltaren and Cataflam, was linked to a 91 percent heightened risk of cardiovascular death. In the United States it is available by prescription; other countries sell it over the counter.
Rofecoxib, which was once sold in the United States as the controversy-mired Vioxx, was associated with a 66 percent greater risk of cardiovascular death in this study. Merck & Co. voluntarily recalled Vioxx in 2004 because of cardiovascular safety concerns, and has not reintroduced it.
Researchers found a two-fold higher risk of heart attack among people taking the highest-level doses of diclofenac and a three-fold risk with the highest does of rofecoxib.
Naproxen, on the other hand, was not associated with heart problem risks in this study. This drug is commonly marketed in the United States as Aleve. Researchers could not conclude anything about the risks of celecoxib, sold as Celebrex in the United States.
Pfizer Inc., maker of Advil and Celebrex, said in a statement that Advil is safe and effective when used according to the label instructions on the package, and the FDA has stated that the benefits of Celebrex outweigh the potential risks in properly selected and informed patients, Pfizer's statement said. McNeil Consumer Healthcare, maker of Motrin, echoed that "When used as directed, ibuprofen is safe and effective." Novartis, maker of Cataflam, said in a statement that the company is aware of the study, and that it "does not change the favorable benefit to risk assessment for diclofenac when used as directed."
"All prescription NSAIDs carry the same cardiovascular warning and may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal," Pfizer's statement noted.
The Danish study has implications for the U.S. population also, researchers said. The American Heart Association advised in 2007 that NSAIDs, except aspirin, for chronic pain upped the risks for heart attack and stroke, which is consistent with these findings.
Talk to your doctor if you have concerns about the medication you are taking.
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