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Published on 26 November 2009

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Vioxx heart risk “was well known”

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Researchers are claiming that the heart-attack risks associated with Merck’s Vioxx (rofecoxib) anti-inflammatory drug were known four years before it was withdrawn from the market.

A team at Mount Sinai School of Medicine has analysed 30 randomised, placebo-controlled trials of Vioxx involving 20,152 individuals taking doses ranging from 12.5 milligrams to 50 milligrams.

They have found that as of December 2000, when 21 of the studies had been completed, there was concern that Vioxx caused a greater risk of heart attacks or blood clots.

In June 2001, data showed a 35% increase in risk of a cardiovascular event or death. In April 2002, the risk was 39%, and 43% in September 2004.

Says team leader Joseph Ross, assistant professor of geriatrics and palliative medicine: “Independent, objective investigators can play a more active role in pharmaceutical safety surveillance, ideally in concert with the FDA and industry.

“Our study is an analytic approach that can be used to inform public health efforts. Comprehensive, rigorous analysis of clinical trial data allows the earlier identification of drug risks, promoting more informed treatment decisions, protecting the public’s health, and perhaps saving lives.”

Copyright © Press Association 2009

European Medicines Agency



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