Unexpected frequent hepatotoxicity of a prescription drug, flupirtine, marketed for about 30 years |
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Authors: | Michel Martin C Radziszewski Piotr Falconer Christian Marschall-Kehrel Daniela Blot Koenraad |
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Affiliation: | Department of Pharmacology & Pharmacotherapy, Academic Medical Center, Amsterdam, The Netherlands. martincmichel@yahoo.de |
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Abstract: | AIMSTo determine efficacy of the analgesic flupirtine in the treatment of overactive bladder syndrome in a proof-of-concept study.METHODSDouble-blind, double-dummy, three-armed comparison of flupirtine extended release (400 mg/day, titrated to 600 mg/day), tolterodine extended release (4 mg/day) and placebo for 12 weeks.RESULTSWhen major elevations of liver enzymes (more than three times the upper normal limit) were detected in several flupirtine-exposed patients, the study was prematurely discontinued. Based on study-end data, hepatotoxicity was detected in 31% of patients receiving flupirtine for ≥6 weeks.CONCLUSIONSUnexpected frequent and relevant toxicity can occur when testing an established drug for a new indication. |
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Keywords: | flupirtine hepatotoxicity overactive bladder syndrome |
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