Modafinil: risks outweigh benefits unless narcoleptic
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Modafinil: risks outweigh benefits unless narcoleptic The European Medicines Agency recommends that the use of modafinil should be restricted to the treatment of narcolepsy only, and marketing authorisations for all other indications should be withdrawn. Doctors and patients are being told not to use the drug to treat idiopathic hypersomnia, excessive sleepiness associated with obstructive sleep apnoea or chronic shift work sleep disorder. The agency’s CHMP conducted a review based on safety concerns relating to psychiatric disorders, and skin and subcutaneous tissue reactions, as well as concerns around significant off-label use and the potential for abuse. The committee concluded that the benefits only outweighed the risks when treating narcolepsy. For all other indications, the risks of skin/hypersensitivity reactions and neuropsychiatric disorders outweighed evidence of the drug’s efficacy. The CHMP also concluded that product information should recommend against prescribing the drug to children, due to the higher risk of skin/hypersensitivity reactions in children, and the drug should be contraindicated in patients with uncontrolled moderate to severe hypertension and in patients with cardiac arrythmias, due to the risk of adverse cardiovascular events. The CHMP’s recommendations have been forwarded to the European Commission for the adoption of a binding decision. EMA. European Medicines Agency recommends restricting the use of modafinil. Media Release : 22 Jul 2010. Available from: URL: http:// 809114785 www.ema.europa.eu
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Reactions 31 Jul 2010 No. 1312
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