title: Abuse liability of flupirtine revisited: implications of spontaneous reports of adverse drug reactions.
abstract: Early studies suggested that the centrally acting non-opioid and non-steroidal analgesic flupirtine (FLP) has no potential for abuse. However, FLP's agonistic effects at the GABAA 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 805 mg (range 200-3,000 mg). 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 >40 years, and long-term FLP-treatment may be possible risk factors for the development of FLP abuse/dependence.
authors.affiliation: Department of Psychiatry and Psychotherapy III, University Hospital of Ulm, Ulm, Germany.
authors.forename: Maximilian
authors.initials: M
authors.lastname: Gahr
authors.forename: Roland W
authors.initials: RW
authors.lastname: Freudenmann
authors.forename: Bernhard J
authors.initials: BJ
authors.lastname: Connemann
authors.forename: Christoph
authors.initials: C
authors.lastname: Hiemke
authors.forename: Carlos
authors.initials: C
authors.lastname: Schönfeldt-Lecuona
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000631:Aminopyridines / Q000009:adverse effects*; D000700:Analgesics / Q000009:adverse effects*; D005260:Female; D005858:Germany / Q000453:epidemiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D019966:Substance-Related Disorders / Q000453:epidemiology*; D055815:Young Adult
chemical_list: D000631:Aminopyridines; D000700:Analgesics; C034161:flupirtine
keywords: addiction; katadolon; misuse; pharmacoepidemiology; pharmacovigilance; substance use disorder