PRAC recommends restricting the use of flupirtine-containing medicines

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Series Details EMA/362055/2013 (14.06.13)
Publication Date 14/06/2013
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The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC), in June 2013, concluded its review of flupirtine-containing medicines and recommended restrictions in their use. The Committee recommended that oral flupirtine medicines and suppositories should only be used to treat acute (short-term) pain in adults who could no use other painkillers (such as NSAIDs and weak opioids) and that treatment should not exceed two weeks. The PRAC’s recommendations follow concerns raised by the German medicines regulatory agency, the Federal Institute for Drugs and Medical Devices (BfArM), about reports of liver problems in patients taking flupirtine.

Flupirtine is a non-opioid painkiller that has been used to treat acute and chronic pain, such as pain associated with muscle tension, cancer pain, menstrual (period) pain and pain following orthopaedic surgery or injuries.

Source Link Link to Main Source http://www.emea.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2013/06/news_detail_001817.jsp&mid=WC0b01ac058004d5c1
Related Links
EMA: Press Release: EMA/362055/2013 (14.06.13) http://www.emea.europa.eu/docs/en_GB/document_library/Press_release/2013/06/WC500144455.pdf
EMA: Press Release: EMA/384191/2013 (28.06.13) http://www.emea.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2013/06/news_detail_001831.jsp&mid=WC0b01ac058004d5c1

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