Unexpected frequent hepatotoxicity of a prescription drug, flupirtine, marketed for about 30 years.
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ABSTRACT: Aims
To determine efficacy of the analgesic flupirtine in the treatment of overactive bladder syndrome in a proof-of-concept study.Methods
Double-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.Results
When 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.Conclusions
Unexpected frequent and relevant toxicity can occur when testing an established drug for a new indication.
SUBMITTER: Michel MC
PROVIDER: S-EPMC3403210 | biostudies-literature | 2012 May
REPOSITORIES: biostudies-literature
Publications
Unexpected frequent hepatotoxicity of a prescription drug, flupirtine, marketed for about 30 years.
Michel Martin C MC Radziszewski Piotr P Falconer Christian C Marschall-Kehrel Daniela D Blot Koenraad K
British journal of clinical pharmacology 20120501 5
<h4>Aims</h4>To determine efficacy of the analgesic flupirtine in the treatment of overactive bladder syndrome in a proof-of-concept study.<h4>Methods</h4>Double-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.<h4>Results</h4>When major elevations of liver enzymes (more than three times the upper normal limit) were detected in several flupirtine-exposed patients, the ...[more]
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