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A blockbuster drug taken by 400,000 people in the UK has been withdrawn from the market after evidence emerged that it more then tripled the risk of heart attacks and sudden death.
Vioxx, made by Merck & Co, the second-largest US pharmaceuticals company, was one of the most heavily-promoted drugs for patients with arthritis, bringing in sales worth $2.5 billion a year.
It belongs to a class of drugs, called coxibs or COX2 inhibitors, designed to control the symptoms of the disease without the damaging side-effects of older drugs such as ibuprofen.
But today Merck said that it was withdrawing the drug in the light of a three-years colon cancer study that confirmed long-standing worries that the drug raised the risk of heart attack and stroke.
"In this study, there was an increased relative risk for confirmed cardiovascular events, such as heart attack and stroke, beginning after 18 months of treatment in the patients taking Vioxx compared to those taking placebo," Merck said.
The results closely matched those of a study by the US Food and Drug Administration this year that suggested patients taking Vioxx faced a 50 per cent greater risk of heart attacks and sudden cardiac death than those taking the rival drug, Celebrex.
At higher doses, the study showed, Vioxx is 3.15 times more likely to cause sudden cardiac death or acute heart attack than is the older drug ibuprofen.
The study also showed that Celebrex does not have this side effect. Patients taking Celebrex were less likely to have a heart attack than those on ibuprofen.
Merck bowed to the results by voluntarily withdrawing Vioxx with immediate effect. The drug has been marketed in more than 80 countries.
"We are taking this action because we believe it best serves the interests of patients," said Raymond Gilmartin, chairman of Merck.
"Although we believe it would have been possible to continue to market Vioxx with labelling that would incorporate these new data, given the availability of alternative therapies, and the questions raised by the data, we concluded that a voluntary withdrawal is the responsible course to take."
The company advised those who have been prescribed Vioxx to discuss with their doctors what alternative they might now take. The most obvious alterbative is Celebrex, made by Pfizer.
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