EMEA recommends benfluorex market withdrawal
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EMEA recommends benfluorex market withdrawal The EMEA has recommended that all medicines containing benfluorex undergo a market withdrawal in the European Union. The EMEA CHMP undertook a review of the safety of benfluorex after both French and Portuguese authorities removed the drug from their respective markets due to safety concerns. The review concluded that benfluorex carried a risk of heart valve disease, and the evidence that the drug was efficacious for the treatment of diabetes was limited. As such, the CHMP have recommended to the European Commission that the drug is withdrawn from the entire European market on the basis that the benefits no longer outweigh the risks. The CHMP have also recommended that physicians stop prescribing the medication, and that patients currently on the medication consult a physician in order to change their prescription. Patients who have been treated with medication containing benfluorex are recommended to be checked for the signs and symptoms of heart valve disease. European Medicines Agency. European Medicines Agency recommends withdrawal of benfluorex from the market in European Union. Media Release : 18 809108212 Dec 2009. Available from: URL: http://www.ema.europa.eu
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Reactions 9 Jan 2010 No. 1283
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