Unexpected frequent hepatotoxicity of a prescription drug, flupirtine, marketed for about 30 years.
Summary of "Unexpected frequent hepatotoxicity of a prescription drug, flupirtine, marketed for about 30 years."
Aim: 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/d, titrated to 600 mg/d), tolterodine extended release (4 mg/d) and placebo for 12 weeks. Results: When major elevations of liver enzymes (>3 times 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. Conclusion: Unexpected frequent and relevant toxicity can occur when testing an established drug in a new indication. What is known about this subject Flupirtine has been on the market for about 30 years in several European countries as an analgesic. This use has not resulted in regulatory action concerning hepatotoxicity. What this study adds When used in a novel indication, hepatotoxicity was frequent with flupirtine, questioning the general assumption that the safety profile in one indication can be extrapolated to other indications.
Affiliation
Dept. Pharmacology & Pharmacotherapy, Academic Medical Center, Amsterdam, The Netherlands Dept. Urology, Medical University of Warsaw, Poland Div. Obstetrics & Gynecology, Danderyt Hospital, Sweden Urological Practice,
Journal Details
This article was published in the following journal.
Name: British journal of clinical pharmacology
ISSN: 1365-2125
Pages:
Links
- PubMed Source: http://www.ncbi.nlm.nih.gov/pubmed/22044433
- DOI: http://dx.doi.org/10.1111/j.1365-2125.2011.04138.x
Medical and Biotech [MESH] Definitions
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A stand-alone drug plan offered by insurers and other private companies to beneficiaries that receive their Medicare Part A and/or B benefits through the Original Medicare Plan. It includes Medicare Private Fee-for-Service Plans that do not offer prescription drug coverage and Medicare Cost Plans offering Medicare prescription drug coverage. The plan was enacted as the Medicare Prescription Drug, Improvement and Modernization Act of 2003 with coverage beginning January 1, 2006.
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Formal programs for assessing drug prescription against some standard. Drug utilization review may consider clinical appropriateness, cost effectiveness, and, in some cases, outcomes. Review is usually retrospective, but some analysis may be done before drugs are dispensed (as in computer systems which advise physicians when prescriptions are entered). Drug utilization review is mandated for Medicaid programs beginning in 1993.
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A broad category of multi-ingredient preparations that are marketed for the relief of upper respiratory symptoms resulting from the COMMON COLD; ALLERGIES; or HUMAN INFLUENZA. While the majority of these medications are available as OVER-THE-COUNTER DRUGS some of them contain ingredients that require them to be sold as PRESCRIPTION DRUGS or as BEHIND-THE COUNTER DRUGS.
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