November 21, 2006
The popular painkiller Naproxen has been linked once again to an increased risk of heart attack and stroke by researchers examining the safety of various headache and arthritis drugs.
Naproxen belongs to a class of painkillers known as non-steroidal anti-inflammatory drugs (NSAIDs), which have come under scrutiny lately. Several studies have linked NSAIDs to increased heart risks, prompting the U.S. Food and Drug Administration to order that the drugs carry a heightened warning label.
The Painkiller Problem
Another class of painkillers called COX-2 inhibitors which includes drugs like Vioxx and Celebrex has also been the subject of recent safety debate. Various studies have shown that these drugs may cause heart attack and stroke. Consequently, makers of these drugs are currently facing thousands of liability lawsuits.
Researchers at the Johns Hopkins University School of Public Health recently conducted a study involving 2,500 elderly participants who were given Celebrex, naproxen, or a placebo for 3.5 years to sort out the risks associated with popular painkillers.
The research came to an abrupt end when concerns began to mount over the safety of COX-2 inhibitors. Still, researchers say the findings are worth noting.
Particularly for safety data, truth’ may come in small doses. We firmly believe that results from trials should be published regardless of the direction, magnitude, or statistical significance of the observed results, said researcher Barbara Martin.
According to the results, 8.25 percent of the patients taking naproxen for more than three years experienced a serious cardiac event or death compared with 5.5 percent of those receiving Celebrex and 5.6 percent a placebo.
Experts, however, are cautioning against reading too much into these results. We don’t have the full answers, said Dr. Steven Nissen of the Cleveland Clinic in Ohio, adding that a large safety trial comparing naproxen, Celebrex, and placebo is currently underway.
Filed under: Big Pharma |