title: Pregabalin abuse and dependence in Germany: results from a database query.
abstract: OBJECTIVE
  Pregabalin (PRG) is approved for the treatment of neuropathic pain, partial seizures and generalised anxiety disorder in many countries and currently under study for other indications. Supported by case reports and the results of a limited number of studies there is an ongoing debate on the potential of PRG to cause addictive behaviours. However, currently available evidence on this issue is sparse, and any definitive assessment of PRG's potential for abuse and dependence is not yet in sight. The aim of our study was to identify the number of cases of PRG abuse or dependence reported to the database of a German medical regulatory body and to obtain insights into further usage-specific parameters.
  
  
  METHODS
  We conducted a query of the entire database of the German Federal Institute for Drugs and Medical Devices (BfArM) regarding reports of PRG abuse or dependence and analysed these cases on the basis of several parameters.
  
  
  RESULTS
  A total of 55 reports of PRG abuse or dependence were identified (mean age 36 years, 64 % of reports involved males). The first reports were submitted to BfArM in 2008, and the reporting frequency has increased up to the present. Mean daily PRG dosage was 1424 mg. Current or previous polytoxicomania was present in 40 and 42 % of cases, respectively. Psychiatric diagnoses other than substance-related disorders were reported in 13 (24 %) cases. In about one-third of the patients withdrawal syndromes subsequent to discontinuation of PRG were reported.
  
  
  CONCLUSIONS
  Cases of PRG abuse or dependence have been reported to the BfArM since 2008, with a marked increase of such reports in subsequent years. Male sex and a history of polytoxicomania may be possible risk factors for the development of addictive behaviours related to PRG.
authors.affiliation: Department of Psychiatry and Psychotherapy III, University Hospital of Ulm, Leimgrubenweg 12-14, 89075 Ulm, Germany. maximilian.gahr@uni-ulm.de
authors.forename: Maximilian
authors.initials: M
authors.lastname: Gahr
authors.forename: Roland W
authors.initials: RW
authors.lastname: Freudenmann
authors.forename: Christoph
authors.initials: C
authors.lastname: Hiemke
authors.forename: Makus A
authors.initials: MA
authors.lastname: Kölle
authors.forename: Carlos
authors.initials: C
authors.lastname: Schönfeldt-Lecuona
mesh_terms: D000293:Adolescent; D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems; D000368:Aged; D000700:Analgesics / Q000009:adverse effects*; D014151:Anti-Anxiety Agents / Q000009:adverse effects*; D000927:Anticonvulsants / Q000009:adverse effects*; D016208:Databases, Factual; D005260:Female; D005858:Germany / Q000453:epidemiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D010818:Practice Patterns, Physicians'; D000069583:Pregabalin; D018570:Risk Assessment; D012307:Risk Factors; D013375:Substance Withdrawal Syndrome / Q000453:epidemiology*; D019966:Substance-Related Disorders / Q000453:epidemiology*; D055815:Young Adult; D005680:gamma-Aminobutyric Acid / Q000009:adverse effects / Q000031:analogs & derivatives*
chemical_list: D000700:Analgesics; D014151:Anti-Anxiety Agents; D000927:Anticonvulsants; D000069583:Pregabalin; D005680:gamma-Aminobutyric Acid