ORIGINAL RESEARCH ARTICLE Disproportionality Analysis for the Assessment of Abuse and Dependence Potential of Pregabalin in the French Pharmacovigilance Database Jean-Baptiste Bossard 1 • Camille Ponte ´ 2 • Julie Dupouy 1,3 • Maryse Lapeyre-Mestre 1,2 • Emilie Jouanjus 1,2 Ó Springer International Publishing Switzerland 2016 Abstract Background and Objective Pregabalin abuse and depen- dence has been increasingly described; however, it is not described in France. Our study aimed to investigate the abuse and dependence potential of pregabalin by a dis- proportionality analysis, in the French Pharmacovigilance Database (FPVD), in comparison with amitriptyline and clonazepam. Methods We performed a case/noncase study in the FPVD. Between January, 1 2010 and December, 31 2015, we identified cases of abuse and or dependence (excluding isolated withdrawal syndromes) using MedDRA (Medical Dictionary for Regular Activities) terms. Exposure to pregabalin was defined as the mention of pregabalin in the report. Clonazepam was used as positive control and amitriptyline as negative control. Results Among the 184,310 reports in the database, 521 were abuse or dependence cases. Exposure to pregabalin was found in eight (1.5 %) of them. We did not find any significant association between exposure to pregabalin and drug abuse or dependence: reporting odds ratio (ROR) = 1.1 95 % confidence interval (CI) (0.6–2.3). ROR for clonazepam was 5.7 95 % CI (3.5–9.2). No case of an amitriptyline-related abuse or dependence was recorded in the FPVD. Conclusions The first cases of pregabalin-related abuse or dependence reported in France occurred later than in other European countries, since none had been described before 2010. This analysis in the FPVD did not find a higher proportion of abuse/dependence with pregabalin in com- parison with other drugs. Considering evidence of prega- balin abuse worldwide, this analysis underlines the limitations of spontaneous reporting system in the field of addictovigilance. Key Points This study reports the first cases of pregabalin abuse and dependence reported to the French Pharmacovigilance system, which appeared later than in other European countries. The part of pregabalin-related abuse and dependence reported to the French pharmacovigilance is not disproportional in comparison with the other adverse effects reported with this drug, whereas statistically significant disproportionality was found with clonazepam. Considering the evidence of the spreading of pregabalin abuse, this analysis underlines the limitations of spontaneous reporting system alone in the field of addictovigilance. Pregabalin abuse potential remains an issue that clinicians should consider when prescribing this drug, especially since the gap between the pregabalin psychotropic effects as perceived by health providers and sought for by abusers. & Emilie Jouanjus emilie.jouanjus@univ-tlse3.fr 1 Equipe de Pharmacoepidemiologie, UMR1027-Universite ´ Paul Sabatier Toulouse III, 37 alle ´es Jules Guesde, 31000 Toulouse, France 2 CEIP-Addictovigilance, Service de Pharmacologie Me ´dicale et Clinique, CHU Toulouse, 37 alle ´es Jules Guesde, 31000 Toulouse, France 3 De ´partement Universitaire de Me ´decine Ge ´ne ´rale, Universite ´ Paul Sabatier Toulouse III, Faculte ´ de Me ´decine, 133, route de Narbonne, Toulouse 31062, France Clin Drug Investig DOI 10.1007/s40261-016-0421-z