Abstract
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.
Highlights
The gabapentinoids pregabalin and gabapentin are being increasingly prescribed for a range of clinical conditions
Key points: - Consistent with increasing levels of prescriptions and rising numbers of related fatalities, pregabalin and gabapentin have recently been reported as possessing addictive liability. Misusers may ingest these molecules in order to achieve euphoric/dissociative effects. - The present study aimed to identify and assess cases of gabapentinoid misuse/dependence as reported to the European Medicines Agency (EMA)’s EudraVigilance (EV) database. -Despite data collection/methodological approach limitations, the present data suggest that gabapentinoid misuse may be a cause for concern, especially in patients with a history of substance misuse
Gabapentinoids at therapeutic dosages may present with a low addictive liability potential, misusers may ingest these molecules in order to achieve euphoric and dissociative effects similar to those of traditional recreational drugs [9,10,11,12,13,14,15]
Summary
The gabapentinoids pregabalin and gabapentin are being increasingly prescribed for a range of clinical conditions. RESULTS: From the EV database 7,639 (6.6% of a total of 115,616), and 4,301 (4.8% of 90,166) ADR 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 adult females. The gabapentinoids pregabalin and gabapentin were originally developed as anticonvulsants and are increasingly [1] and widely prescribed for a range of clinical conditions [2] Both drugs have been reported as possessing a distinct potential for misuse [3,4,5,6,7,8]. The suspected ADRs originate from ‘spontaneous case reports’, defined as follows: ‘an unsolicited communication by a healthcare professional, or consumer, to a competent authority .... that describes one or more suspected adverse reactions in a patient who was given one or more medical products ....’ [51]
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