Summary
The U.S. Food and Drug Administration has determined that as many as 140,000 American patients may have suffered heart damage from the arthritis drug Vioxx. According to researchers, many of the cases have been fatal. Merck & Co. removed Vioxx from the market after clinical trials linked the drug to an increased risk of heart attack and stroke.
Original source:
http://www.healthtalk.ca/vioxx_study_published_010525_39022.php
Details
A controversial study of Vioxx, the arthritis painkiller drug removed from the market in September, has finally been published in the British medical journal The Lancet.
The US Food and Drug Administration study, by lead researcher Dr. David Graham, of the FDA's office of drug safety suggests as many as 140,000 patients in the US may have suffered serious heart damage from taking Vioxx.
Graham says many of the cases may have been fatal.
The study was originally slated to be published in November, however, Graham, says the FDA threatened to dismiss him if the study appeared in a medical journal.
Vioxx was voluntarily removed from the market by Merck & Co. when clinical trials linked the Cox-2 inhibitor to an increased heart attack and stroke risk.
Graham's study compared the incidence of coronary heart disease in patients taking Vioxx and other non-steroidal anti-inflammatory drugs (NSAIDs).
Graham and colleagues looked at 1.4 million patients in California who had been prescribed Vioxx and other NSAIDs from 1999 to 2004.
The team reported finding more than 8000 cases of coronary heart disease and just over 1,500 sudden cardiac deaths.
Patients taking Vioxx had a 34 percent greater chance of coronary heart disease, compared with those taking other NSAIDs, according to Graham's findings.
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Tuesday, February 01, 2005
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