EMEA recommends veralipride withdrawal
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EMEA recommends veralipride withdrawal The EMEA has announced that it recommends withdrawal of the marketing authorisation for medicinal products containing veralipride.1 The EMEA advises that a review of all available data on the safety and efficacy of veralipride by its CHMP concluded that the risks of the drug in the treatment of hot flushes associated with menopause exceed its benefits.1 The CHMP found that veralipride demonstrates limited efficacy, and is associated with adverse effects such as anxiety, depression and tardive dyskinesia, both during and after treatment. The EMEA explains that this review was conducted under an ‘Article 31’ procedure following a request from the European Commission in September 2006. This was triggered by the withdrawal of veralipride in Spain and also by regulatory actions in other European Union member states where the drug is authorised. The EMEA advises that patients who are receiving veralipride for hot flushes should contact their doctor to discuss other treatment options if necessary. It cautions that treatment should not be stopped abruptly and the dosage of veralipride should be decreased gradually. Veralipride was first available in 1979 and is still authorised in Belgium, Italy, France, Luxembourg and Portugal under the trade names Agreal and Agradil.2 1. EMEA. European Medicines Agency recommends withdrawal of medicinal products containing veralipride. Media Release : 23 Jul 2007. Available from: URL: http://www.emea.europa.eu. 2. European Medicines Agency. Questions and answers on the recommendation to withdraw the marketing authorisation of veralipride. Internet Document : [2 pages], 23 Jul 2007. Available from: URL: http://www.emea.europa.eu. 801069783
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Reactions 28 Jul 2007 No. 1162
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