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Thursday, September 30, 2004Drug company Merck has removed its arthritis painkiller Vioxx because of data showing an increased risk of heart attack and stroke. ...A three-year trial showed an increased risk of cardiovascular events began after 18 months of Vioxx treatment. ...Merck's chairman Raymond Gilmartin said: "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." There's not much available on the study that led to the decision to withdraw the drug from the market, but the FDA press release says it was a study comparing Vioxx to placebo in the prevention of colon polyps, and that the risk was small: The Agency was informed by Merck & Co., Inc. on September 27, 2004, that the Data Safety Monitoring Board for an ongoing long-term study of Vioxx (APPROVe) had recommended that the study be stopped early for safety reasons. The study was being conducted in patients at risk for developing recurrent colon polyps. The study showed an increased risk of cardiovascular events (including heart attack and stroke) in patients on Vioxx compared to placebo, particularly those who had been taking the drug for longer than 18 months. Based on this new safety information, Merck and FDA officials met the next day, September 28, 2004, and during that meeting FDA was informed that Merck was voluntarily withdrawing Vioxx from the market place. The risk that an individual patient taking Vioxx will suffer a heart attack or stroke related to the drug is very small. Patients who are currently taking Vioxx should contact their physician for guidance regarding discontinuation and alternative therapies. More details at Merck's website, although the actual data isn't available. It's difficult to say how serious the risk is, though previous studies that have suggested the same have shown very, very small increases in the absolute risk. (in the tenth of a percent range), which would suggest that there are probably other factors involved beyond purely the use of these anti-inflammatory drugs. Factors such as the absence of the use of prophylactic aspirin in Vioxx users. One of the previous studies that suggested Vioxx was a problem compared it to Naprosyn, an anti-inflammatory of an older class which has an effect on platelet metabolism not seen with the newer drugs such as Vioxx. Since platelets play a role in blood clotting, it was thought that Vioxx's disadvantage in the heart disease department could be explained by it's lack of platelet action. This was the same quality that supposedly made it more favorable in terms of bleeding complications. But the latest decision was based on a study that was comparing the drug to placebo. Again, the key to knowing how much to worry about it if you're a Vioxx user is in knowing the absolute risks involved, and whether or not aspirin use was controlled for in the placebo group. We don't have that data. In today's climate, though, it isn't surprising that Merck would pull the drug from the market. Any negative results, no matter how small, would surely be a death sentence for the drug in today's legal environment. posted by Sydney on 9/30/2004 01:03:00 PM 0 comments 0 Comments: |
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