Disproportionality Analysis for the Assessment of Abuse and Dependence Potential of Pregabalin in the French Pharmacovigilance Database.
OBJECTIVE
Pregabalin abuse and dependence 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 disproportionality 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 comparison with other drugs. Considering evidence of pregabalin abuse worldwide, this analysis underlines the limitations of spontaneous reporting system in the field of addictovigilance.
Equipe de Pharmacoepidemiologie, UMR1027-Université Paul Sabatier Toulouse III, 37 allées Jules Guesde, 31000, Toulouse, France.
Jean-Baptiste
JB
Bossard
CEIP-Addictovigilance, Service de Pharmacologie Médicale et Clinique, CHU Toulouse, 37 allées Jules Guesde, 31000, Toulouse, France.
Camille
C
Ponté
Equipe de Pharmacoepidemiologie, UMR1027-Université Paul Sabatier Toulouse III, 37 allées Jules Guesde, 31000, Toulouse, France.|Département Universitaire de Médecine Générale, Université Paul Sabatier Toulouse III, Faculté de Médecine, 133, route de Narbonne, Toulouse, 31062, France.
Julie
J
Dupouy
Equipe de Pharmacoepidemiologie, UMR1027-Université Paul Sabatier Toulouse III, 37 allées Jules Guesde, 31000, Toulouse, France.|CEIP-Addictovigilance, Service de Pharmacologie Médicale et Clinique, CHU Toulouse, 37 allées Jules Guesde, 31000, Toulouse, France.
Maryse
M
Lapeyre-Mestre
Equipe de Pharmacoepidemiologie, UMR1027-Université Paul Sabatier Toulouse III, 37 allées Jules Guesde, 31000, Toulouse, France. emilie.jouanjus@univ-tlse3.fr.|CEIP-Addictovigilance, Service de Pharmacologie Médicale et Clinique, CHU Toulouse, 37 allées Jules Guesde, 31000, Toulouse, France. emilie.jouanjus@univ-tlse3.fr.
Emilie
E
Jouanjus
D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems; D000368:Aged; D000639:Amitriptyline / Q000009:adverse effects; D000929:Antidepressive Agents, Tricyclic / Q000009:adverse effects; D002998:Clonazepam / Q000009:adverse effects; D016208:Databases, Factual; D005260:Female; D005602:France; D018757:GABA Modulators / Q000009:adverse effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D060735:Pharmacovigilance; D000069583:Pregabalin / Q000009:adverse effects*; D019966:Substance-Related Disorders / Q000453:epidemiology*
D000929:Antidepressive Agents, Tricyclic; D018757:GABA Modulators; D000639:Amitriptyline; D000069583:Pregabalin; D002998:Clonazepam