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drug_recall vioxxVioxx is a $2.5 billion a year drug made by Merck & Co. Over the last few years, the company has experienced slumping sales because of debates over the safety of the arthritis drug. In perhaps the biggest blow yet, a large study financed by the Food and Drug Administration (FDA) was presented at an August 2004 conference suggesting the use of the drug increases the danger of heart attacks. Now, Vioxx warnings have been issued while Kaiser Permanente, one of the biggest U.S. health maintenance organizations with more than 8 million members, is reconsidering its use of Vioxx.
Patients and doctors have been questioning the safety of Vioxx for the past several years and believe this latest study warrants strong Vioxx warnings. The authors of the study said "this and other studies cast serious doubt on the safety of high doses of Vioxx". When Vioxx first entered the market there were high hopes for the drug known as a Cox-2 inhibitor. Compared to older painkillers, Vioxx makers stated the Cox-2 drug was a breakthrough because it no longer carried risk of gastrointestinal problems like the older painkillers. A year after its 1999 launch, Vioxx warnings were issued, finding the drug did carry gastrointestinal risks but at a reduced danger.
Even before Vioxx was ever launched, Merck''s 8,000 patient trial of the drug showed over twice as many arthritis patients taking it had heart attacks and strokes when compared to naproxen, one of the most popular older arthritis treatments. The company has been criticized for failing to recognize the initial Vioxx warnings, but Merck has argued Vioxx was not the problem and that the data was maybe reflecting naproxen''s ability to prevent heart attacks instead. Lead investigator for the latest FDA trial said that his trial actually suggested naproxen slightly increases the risk of heart attacks, further putting Merck in bad light.
Merck has continued to maintain over the years that Vioxx is safe, but independent researchers have cited cardiovascular risks and the safety concerns have noticeably affected sales. An August 21 issue of the British medical journal The Lancet claims greater Vioxx warnings should be implemented and that "the continued commercial availability of rofecoxib, without a black-box warning for cardiovascular patients, is indeed troubling." Vioxx warnings saying there may be an increased risk of cardiovascular disease associated with the Cox-2 class of drugs have been given despite saying the evidence is still inconclusive.
The Vioxx findings were discovered after analyzing the medical records of 1.4 million people insured by Kaiser. Members between 1999 and 2001 taking Vioxx had 8,199 reports of heart attacks and cases of sudden cardiac death. A major part of the findings was that the patients taking the typical starting dose of Vioxx had a 50 percent greater chance of heart attack and sudden cardiac death than patients taking any dose of Celebrex, a rival Cox-2 drug.
Vice president of clinical research at Merck has commented that the study was "observational", but many already skeptical patients think the continued debate without additional Vioxx warnings to take a stronger stance has gone on for too long.
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.
The settlement is reportedly the larg...
An Idaho state jury has found that the painkiller Vioxx contributed to the heart attack of a postal worker. The jury awarded him and his wife a multimillion-dollar verdict.
Frede...