A Decade of Gabapentinoid Misuse: An Analysis of the European Medicines Agency’s ‘Suspected Adverse Drug Reactions’ Database
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The gabapentinoids pregabalin and gabapentin are being increasingly prescribed for a range of clinical conditions. Recently, although gabapentinoids at therapeutic dosages may present with low addictive liability levels, cases of misuse and rising numbers of related fatalities have been reported.
The aim of the study was to identify and assess cases of gabapentinoid misuse or dependence as reported to the European Medicines Agency’s EudraVigilance database, to identify the magnitude of this problem and the characteristics of these reactions.
All spontaneous reports of both gabapentin- (2004–2015) and pregabalin- (2006–2015) related misuse/abuse/dependence were retrieved. A descriptive analysis by source, sex, age, and type of report was performed.
From the EudraVigilance database 7639 (6.6 % of a total of 115,616) and 4301 (4.8 % of 90,166) adverse drug reaction reports of misuse/abuse/dependence were, respectively, associated with pregabalin and gabapentin, with an overall reporting frequency increasing over time. For both molecules, subjects typically involved were female adults. A total of 27 and 86 fatalities, respectively, associated with pregabalin and gabapentin, and mostly in combination with opioids, were identified. Analysis of proportional reporting ratios for drug abuse/dependence/intentional product misuse values seem to indicate that these adverse drug reactions were more frequently reported for pregabalin (1.25, 1.39, and 1.58, respectively) compared with gabapentin.
Despite data collection/methodological approach limitations, the present data seem to suggest that gabapentinoid misuse may be a cause for concern, especially in patients with a history of substance misuse. Hence, healthcare professionals should be vigilant when prescribing these molecules.
KeywordsGabapentin Generalize Anxiety Disorder Pregabalin European Medicine Agency Substance Misuse
We acknowledge the support offered by the EMA in providing access to the EV database. The views expressed here are those of the authors and do not necessarily reflect the EMA officers’ views.
Compliance with Ethical Standards
In contributing to this paper, FS was supported in part by grants of the European Commission (Drug Prevention and Information Programme 2014–16, contract no. JUST/2013/DPIP/AG/4823, EU-MADNESS project). Further financial support was provided to FS by the EU Commission-targeted call on cross border law enforcement cooperation in the field of drug trafficking, DG Justice/DG Migrations and Home Affairs (JUST/2013/ISEC/DRUGS/AG/6429) Project EPS/NPS (Enhancing Police Skills concerning Novel Psychoactive Substances).
Conflict of interest
Prof. Schifano and Dr. Chiappini report no conflicts of interest with respect to the content of this manuscript; however, Prof. Schifano is a member of the EMA Psychiatry Advisory Board.
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