June 8, 2010 -- High doses of common painkillers raise the risk of heart death in healthy people, a huge Danish study finds.
It's the first evidence that so-called NSAID (nonsteroidal anti-inflammatory drug) pain relievers -- including some sold over the counter -- increase the risk of heart disease and death in people without underlying health conditions.
The risks are dose related and are mostly associated with high doses of the drug. However, for most of the drugs, the deaths occurred in people who had been taking the drugs for only two weeks.
"We found that most NSAIDs are associated with increased cardiovascular mortality and morbidity," says researcher Emil Loldrup Fosbol, MD, of Gentofte University Hospital in Hellerup, Denmark.
The study's most disturbing finding: Diclofenac (brand names include Cataflam, Voltaren) is as risky as the now-banned Vioxx. Both diclofenac and Vioxx nearly doubled the risk of death from heart disease among healthy people in the Fosbol study.
Although diclofenac is available in the U.S. only by prescription, it's sold over the counter in many nations.
Ibuprofen Heart Risk
Although low doses of ibuprofen seemed to lower the risk of heart attack, the study found a trend toward increased heart attack risk with high doses (more than 1,200 milligrams per day or more than two 200 milligram pills three times daily).
Based on other evidence, an American Heart Association panel in 2007 warned that treating chronic pain with NSAIDs other than aspirin increases a person's risk of heart attack and stroke. The lead author of that AHA statement, Elliot M. Antman of Harvard Medical School and Brigham and Women's Hospital, says the Fosbol findings underscore the importance of those recommendations.
"Doses examined in this new study were very similar to doses that patients are likely to encounter both at the over-the-counter level and the prescription level," Antman says in a news release.
However, all NSAIDS, including naproxen, increase the risk of potentially fatal bleeding.
Previous studies of NSAID risk examined people with underlying health conditions. The Fosbol study differs. Because detailed medical records are available for everyone in Denmark, the researchers were able to study NSAID risk in more than a million healthy people from 1997 to 2005.
Although NSAIDs increased the risk of death from heart disease, the risk was small. Among the 1,028,437 people who took NSAIDs, there were 769 deaths from heart disease and stroke.
Even so, the finding that NSAIDs increase heart risk in relatively healthy people is important, says Howard S. Weintraub, MD, clinical director of the NYU Langone Center for the Prevention of Cardiovascular Disease.
"This could have far-reaching implications, as many individuals rely on these drugs for pain relief," Weintraub says in a news release. "It is likely that sporadic, non-sustained use of NSAIDs in low doses for pain relief will remain safe, while more chronic use of higher doses may have to be questioned."
What about people already taking NSAIDs for chronic pain?
"For patients regularly taking an NSAID now -- whether it's prescription or OTC -- it is advisable to discuss with your physician why it was originally recommended or prescribed, whether you need to continue taking it, and at what dose," Antman says.
The Fosbol study appears in the June 8 online edition of the AHA journal Circulation: Cardiovascular Quality and Outcomes.