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drug_recall vioxxNew research suggests the risk of Vioxx heart attacks may be three times higher than people not taking the medication. A study funded by the U.S. Food and Drug Administration (FDA) analyzed medical records of patients insured by one of the largest U.S. health maintenance organizations, Kaiser Permanente. According to the study, 26,748 patients had taken Vioxx and 40,405 had taken its rival drug Celebrex. The study revealed there was a 50 percent greater risk of Vioxx heart attacks or sudden cardiac death than with Celebrex users.
Sudden cardiac death is the biggest cause of death in the U.S. The implications of the study finding 8,199 Vioxx heart attacks and cases of sudden cardiac death among Kaiser members between 1999 and 2001 have left a lot up for personal interpretation. The popularity of Vioxx has experienced great setbacks over the last several years because of the safety debate. Merck has continued to maintain Vioxx is safe, though clearly based on sales. Physicians and patients are not convinced.
Vioxx is a COX-2 inhibitor drug, designed to reduce the risk of gastrointestinal damage caused by other arthritis drugs. Safety concerns dating as far back as 2001 have suggested links between Vioxx and heart attacks. Over the years, the previous studies cited in the FDA report have found a higher risk of Vioxx heart attacks and similar problems to occur, which has led some health insurers to put limits on its use.
The study reports that Vioxx heart attack rates tripled for patients taking doses higher than 25 milligrams per day. While lower doses of the drug also increased risk of Vioxx heart attacks, it was not as significant as with taking 25 milligrams or greater. Dr. David Graham, an FDA senior scientist for the Office of Drug Safety, said that it was his interpretation of evidence in the study that doctors should not prescribe high dosage Vioxx. Also, patients should avoid taking the high dosages because of the significant elevated risk of Vioxx heart attack and sudden cardiac death it may be linked to.
Kaiser responded to the study saying it would review and discuss the findings before acting, as well as to look to the FDA to see its response to the data. Before Vioxx was launched, a Merck patient trial of the arthritis drug in 1999 had already showed over twice as many of the 8,000 Vioxx patients had heart attacks and strokes than those taking naproxen, one of the most popular older arthritis treatments. Merck has argued Vioxx heart attacks were not suffered at a higher incidence than naproxen, but that naproxen was somehow preventing heart attacks. Graham has said his trial suggests that in fact naproxen may actually slightly increase risk of heart attacks.
Independent researchers have cited the Vioxx heart attacks link over the years, and the FDA funded study may finally end up leading to tighter federal regulations of the arthritis drug and a possible ban of at least high-doses of Vioxx.
Two reports released Wednesday reveal that Merck waged a deceptive promotional campaign for its top-selling painkiller Vioxx and disguised company studies as the work of outside scientists.
JAMA Studies
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The third-largest drugmaker in the U.S, Merck, agreed to settle a majority of their claims involving the painkiller Vioxx for $4.85 billion.
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Frede...