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June 8, 2010

A new study has found that healthy people who take certain NSAID (Nonsteroidal anti-inflammatory drugs) pain relievers may increase their risk of heart attack and stroke.

People commonly use NSAIDs, especially OTC formulations, to reduce fever and relieve pain caused by conditions such as arthritis, headache, toothache, back pain, muscle pain, menstrual cramps or minor injury.

Previous studies linked NSAIDs and cardiovascular risks in persons with other high risk factors or established heart disease, however this study is the first to measure the increased cardiovascular risk caused by NSAIDs in healthy people.

“We conducted this study to answer whether any specific NSAID carried a risk of cardiovascular adverse events among healthy individuals and to explore if there were safer alternatives within the group of NSAIDs,” study authors said.

Researchers in Denmark studied 1,028,437 healthy Danish individuals with an average age of 39 from January 1, 1997 to December 31, 2005 for increased cardiovascular morbidity and mortality with the use of rofecoxib (Vioxx), diclofenac, celecoxib, naproxen and ibuprofen.

Rofecoxib, marketed as the brand name Vioxx, is no longer available in the United States. Merck voluntarily withdrew the drug from the market in 2004 after studies showed an increased risk of heart attack and stroke. Vioxx was widely used in the U.S. before its withdrawal, generating $2.5 billion in sales revenue in 2003.

Diclofenac, marketed as brand names Cambia, Cataflam, Voltaren, Voltaren-XR and Zipsor, and Celecoxib marketed as Celebrex are only available by prescription in the U.S., while consumers can purchase ibuprofen over-the-counter (OTC) as brand names such as Advil, Motrin, Midol and Nuprin. Naproxen is available by prescription, but consumers can also purchase naproxen (Aleve) over-the-counter.

According to Healthday News, compared to people who took no NSAIDs, researchers of the study found that patients taking diclofenac had a 91% higher risk of death from heart attack and stroke, much higher than the 66% increased risk for those taking rofecoxib (Vioxx). People taking the largest doses of diclofenac saw risk of heart attack doubled and for those taking the largest doses of rofecoxib (Vioxx) risk tripled.

Perhaps the most relevant study finding for U.S consumers self-medicating with OTC ibuprofen products is that ibuprofen showed a 29% higher risk of stroke.

Researchers found no increased risk of heart attack or stroke with use of naproxen. Their analyses of celecoxib were not conclusive.

“Because treatment with NSAIDs is so widely distributed in the general population, it is also of great importance that a safe alternative is found when NSAID treatment cannot be avoided. The safety of naproxen has been much debated, but it is widely accepted that naproxen is probably the NSAID with the safest cardiovascular risk profile, and our results support this assumption,” the researchers said. “Our results suggest that naproxen could be a safer alternative when NSAID treatment is required.”

The study appears in the June 8, 2010 issue of Circulation: Cardiovascular Quality and Outcomes, a Journal of the American Heart Association.

The U.S. Food and Drug Administration (FDA) requires drug labels for NSAIDs to warn of increased risk of heart attack or stroke associated with long-term continuous use of the drug. The Denmark study population had a median exposure time to NSAIDs of 14 days, indicating short-time exposure in most individuals.

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