Some Popular Pain Pills Increase Heart Deaths

June 8, 2010— -- A headache makes it hard to think of anything else but how to stop it, and when there's a job to be done, a little bottle of pills seems so handy. Some people buy over-the-counter pain pills as often as they buy gum.

But a large study has found that some of the most popular pain pills are associated with a higher risk of heart-related deaths in healthy people.

Danish researchers investigated the health records of 1,028,437 "healthy" people over the age of 10, which they collected from 1997 through 2005, and found some pain pills were linked to more heart-related deaths than others.

People taking ibuprofen -- sold under the brand names Advil, Motrin, Nuprin -- had a 29 percent increased risk of strokes. A popular drug in Europe called diclofenac, or Voltaren, was associated with a 91 percent increased risk of heart-related deaths, and the now-defunct drug rofecoxib, or Vioxx, was linked to a 66 percent jump in heart-related deaths.

By "healthy," researchers chose study subjects who had not been admitted to Danish hospitals for five years and had not taken prescription drugs for any serious condition in two years. About 45 percent of those included in the study had taken nonsteroidal anti-inflammatory drugs, or NSAIDS -- the type of pain pill studied -- at least once during the period of the study, often taking them for a two-week period.

Although the authors observed an increased risk of heart problems, the absolute number of heart-related deaths was small. Out of 1 million people studied, 769 died from heart-related causes. That adds up to 0.075 percent of the study's population.

One drug studied, naproxen (Aleve), showed no increase in heart-related problems.

In the United States, all NSAIDs have carried a warning since April 2005 about the excess risk of cardiovascular problems, but the level of risk has not been quantified, explained the authors of the study published today in Circulation: Cardiovascular Quality and Outcomes, a journal of the American Heart Association.

Lead author Dr. Emil Loldrup Fosbøl, of Gentofte University Hospital in Hellerup, Denmark, wrote that the study was the "first to our knowledge to report on the specific cardiovascular risk among healthy individuals."

Pain specialists said the study only reaffirmed the findings that some nonsteroidal anti-inflammatory drugs are probably bad for the heart.

Previous Studies Found Heart Risks for Pain Pills

"This is the latest in a series of studies going back nearly 10 years, including several from our research group ... that make it clear that naproxen is the safest NSAID in terms of cardiovascular risk, and that drugs like rofecoxib (Vioxx) and diclofenac (Voltaren) significantly increase the risk of heart disease," said Dr. Jerry Avorn, professor at Harvard Medical School and chief of pharmacoepidemiology and pharmacoeconomics at Brigham and Women's Hospital in Boston.

Vioxx was pulled from the market in 2004 because of studies showing a higher rate of heart problems in patients taking the drug versus a placebo. The study found that taken at the highest doses, Voltaren was associated with a double risk of a heart attack, and Vioxx with a triple risk.

"While Vioxx was pulled from the shelves -- long after such data was widely available -- diclofenac (Voltaren) is still in widespread use, for no good reason," said Avorn.

"A take-home message for patients is to remember that despite the feel-good drug commercials that we're all exposed to daily, all medications that work have risks, including those sold over the counter," he said.

Dr. Gregg Fonarow, a UCLA professor of cardiology and director of the Ahmanson-UCLA Cardiomyopathy Center, said patients who are taking any over-the-counter meds regularly should talk with their doctor.

"Individuals who every now and then take a few doses of NSAIDs -- they do not need to be concerned about this," said Fonarow. "But it's important for individuals to follow current guidelines, which includes only using medicine when indicated, trying to use the lowest dose and for the shortest duration possible."

But other heart specialists did not believe that the study was definitive enough to change which pain medications are prescribed and when.

"These kinds of studies have been out and around. They're observational, they're not randomized trials," said Dr. Steven E. Nissen, vice chairman of cardiology at the Cleveland Clinic Foundation in Cleveland.

Nissen is currently conducting a randomized trial on the very topic to pinpoint how much NSAIDs influence cardiac risks. He expects that eventually research will define which drugs are risky and when to avoid them.

"But I don't think people can make a decision on what drug to take on the basis of this study," he said.