Abuse Liability of Flupirtine Revisited: Implications of Spontaneous Reports of Adverse Drug Reactions

作者:Gahr Maximilian*; Freudenmann Roland W; Connemann Bernhard J; Hiemke Christoph; Schoenfeldt Lecuona Carlos
来源:The Journal of Clinical Pharmacology, 2013, 53(12): 1328-1333.
DOI:10.1002/jcph.164

摘要

Early studies suggested that the centrally acting non-opioid and non-steroidal analgesic flupirtine (FLP) has no potential for abuse. However, FLP%26apos;s agonistic effects at the GABA(A) receptor might prime addictive behaviors, and literature provides some anecdotal reports on FLP abuse/dependence. To shed more light on this topic we acquired and evaluated data obtained from a national German pharmacovigilance database. We analyzed all reports of FLP abuse/dependence that were recorded in the database of the German Federal Institute for Drugs and Medical Devices (BfArM). A total of n=48 reports of FLP abuse/dependence could be identified (mean age 45 years, 62.5% female). First reports were submitted to BfArM in 1991 with increasing numbers of annual reports from the year 2006 on. Mean daily FLP dosage was 805mg (range 200-3,000mg). Current or previous substance abuse/dependence was reported in 21% and 17%, respectively. Mean duration of FLP abuse/dependence until report to BfArM was 23 months (range 1-84 months). Withdrawal syndromes after discontinuation of FLP were reported in n=9 (19%). Our findings strengthen the hypothesis that FLP features a potential to cause addictive behaviors. Female sex, age %26gt;40 years, and long-term FLP-treatment may be possible risk factors for the development of FLP abuse/dependence.

  • 出版日期2013-12