ema reviews benefits, risks of flupirtine

Reactions 1447 - 13 Apr 2013 ■ The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) will review the benefits and risks of flupirtine-containing medicines, following a request from Germany. The German medicines agency (BfArM) has received an increasing number of reports of liver disorders associated with use of the analgesic, ranging from reports of elevated liver enzymes through to liver failure. In total, the German ADR database contains 330 reports of such liver disorders, including 15 which had a fatal outcome or resulted in liver transplantation. The German agency has also noted a lack of data supporting the drug’s effectiveness in treating long-term pain. In 2011, the total patient exposure to flupirtine in Germany was estimated to be 28.1 million defined daily doses. EMA. Review of flupirtine-containing medicines started. Internet Document : [2 pages], 7 Mar 2013. Available from: URL: http:// www.ema.europa.eu 803085789 1 Reactions 13 Apr 2013 No. 1447 0114-9954/10/1447-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved

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Page 1: EMA reviews benefits, risks of flupirtine

Reactions 1447 - 13 Apr 2013

■ The EMA’s Pharmacovigilance Risk AssessmentCommittee (PRAC) will review the benefits and risks offlupirtine-containing medicines, following a requestfrom Germany. The German medicines agency(BfArM) has received an increasing number of reportsof liver disorders associated with use of the analgesic,ranging from reports of elevated liver enzymesthrough to liver failure. In total, the German ADRdatabase contains 330 reports of such liver disorders,including 15 which had a fatal outcome or resulted inliver transplantation. The German agency has alsonoted a lack of data supporting the drug’seffectiveness in treating long-term pain. In 2011, thetotal patient exposure to flupirtine in Germany wasestimated to be 28.1 million defined daily doses.EMA. Review of flupirtine-containing medicines started. Internet Document :[2 pages], 7 Mar 2013. Available from: URL: http://www.ema.europa.eu 803085789

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Pelatihan EMA EMA-SEAblog.ub.ac.id/adampartner/files/2013/01/Kuliah-Analisis... · 2013. 1. 8. · Pengantar EMA: EMA untuk Pengambilan Keputusan yang lebih baik PPBN Pusat Produksi

New analgesic in the management of pain in this millennium recent perspectives-flupirtine