Disproportionality Analysis for the Assessment of Abuse and Dependence Potential of Pregabalin in the French Pharmacovigilance Database

Clinical Drug Investigation

Volumn 36, Issue 9, 2016, Pages 735-742

  Bossard, Jean Baptiste ^a   Ponté, Camille ^b   Dupouy, Julie ^a   Lapeyre Mestre, Maryse ^a,b   Jouanjus, Emilie ^a,b  

^a UNIVERSITÉ PAUL SABATIER   (France)

^b TOULOUSE UNIVERSITY HOSPITAL   (France)

Author keywords

[No Author keywords available]

Indexed keywords

AMITRIPTYLINE; CLONAZEPAM; PREGABALIN; BENZODIAZEPINE RECEPTOR AFFECTING AGENT; TRICYCLIC ANTIDEPRESSANT AGENT;

ADULT; ARTICLE; CONTROLLED STUDY; DATA BASE; DRUG ABUSE; DRUG DEPENDENCE; DRUG SURVEILLANCE PROGRAM; FEMALE; FRANCE; HUMAN; MAJOR CLINICAL STUDY; MALE; PRIORITY JOURNAL; AGED; FACTUAL DATABASE; MIDDLE AGED; SUBSTANCE-RELATED DISORDERS;

ADULT; ADVERSE DRUG REACTION REPORTING SYSTEMS; AGED; AMITRIPTYLINE; ANTIDEPRESSIVE AGENTS, TRICYCLIC; CLONAZEPAM; DATABASES, FACTUAL; FEMALE; FRANCE; GABA MODULATORS; HUMANS; MALE; MIDDLE AGED; PHARMACOVIGILANCE; PREGABALIN; SUBSTANCE-RELATED DISORDERS;

EID: 84974834773     PISSN: 11732563     EISSN: 11791918     Source Type: Journal    
DOI: 10.1007/s40261-016-0421-z     Document Type: Article

References (38)

1. Sills GJ. The mechanisms of action of gabapentin and pregabalin. Curr Opin Pharmacol. 2006;6(1):108–13.
2. Matsuzawa R, Fujiwara T, Nemoto K, Fukushima T, Yamaguchi S, Akagawa K, et al. Presynaptic inhibitory actions of pregabalin on excitatory transmission in superficial dorsal horn of mouse spinal cord: further characterization of presynaptic mechanisms. Neurosci Lett. 2014;558:186–91.
3. Lapeyre-Mestre M, Dupui M. Drug abuse monitoring: which pharmacoepidemiological resources at the European level? Thérapie. 2015;70(2):147–65.
4. Filipetto FA, Zipp CP, Coren JS. Potential for pregabalin abuse or diversion after past drug-seeking behavior. J Am Osteopath Assoc. 2010;110(10):605–7.
5. Grosshans M, Mutschler J, Hermann D, Klein O, Dressing H, Kiefer F, et al. Pregabalin abuse, dependence, and withdrawal: a case report. Am J Psychiatry. 2010;167(7):869.
6. Schwan S, Sundström A, Stjernberg E, Hallberg E, Hallberg P. A signal for an abuse liability for pregabalin—results from the Swedish spontaneous adverse drug reaction reporting system. Eur J Clin Pharmacol. 2010;66(9):947–53.
7. Caster O, Edwards IR, Norén GN, Lindquist M. Earlier discovery of pregabalin’s dependence potential might have been possible. Eur J Clin Pharmacol. 2011;67(3):319–20.
8. European Medicines Agency (EMA). Lyrica Procedural steps taken and scientific information after the authorisation [Internet]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Procedural_steps_taken_and_scientific_information_after_authorisation/human/000546/WC500046604.pdf. Accessed 12 June 2016.
9. Gahr M, Freudenmann RW, Hiemke C, Kölle MA, Schönfeldt-Lecuona C. Pregabalin abuse and dependence in Germany: results from a database query. Eur J Clin Pharmacol. 2013;69(6):1335–42.
10. Grosshans M, Lemenager T, Vollmert C, Kaemmerer N, Schreiner R, Mutschler J, et al. Pregabalin abuse among opiate addicted patients. Eur J Clin Pharmacol. 2013;69(12):2021–5.
11. Kapil V, Green JL, Le Lait M-C, Wood DM, Dargan PI. Misuse of the γ-aminobutyric acid analogues baclofen, gabapentin and pregabalin in the UK. Br J Clin Pharmacol. 2014;78(1):190–1.
12. Schjøtt J, Bergman J. Joint medicine-information and pharmacovigilance services could improve detection and communication about drug-safety problems. Drug Healthc Patient Saf. 2014;6:89–92.
13. Assurance Maladie. ameli.fr - Medic’AM [Internet]. ameli.fr. Available from: http://www.ameli.fr/l-assurance-maladie/statistiques-et-publications/donnees-statistiques/medicament/medic-am/medic-am-2012-2014.php. Accessed 12 June 2016.
14. Fuzier R, Serres I, Guitton E, Lapeyre-Mestre M, Montastruc JL, French Network of Pharmacovigilance Centres. Adverse drug reactions to gabapentin and pregabalin: a review of the French pharmacovigilance database. Drug Saf. 2013;36(1):55–62.
15. Arimone Y, Bidault I, Dutertre J-P, Gérardin M, Guy C, Haramburu F, et al. Updating the French method for the causality assessment of adverse drug reactions. Thérapie. 2013;68(2):69–76.
16. European Parliament and Council of Ministers. Directive 2010/84/EU [Internet]. Available from: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:348:0074:0099:EN:PDF. Accessed 12 June 2016.
17. ANSM: Agence nationale de sécurité du médicament et des produits de santé. Pharmacodépendance (Addictovigilance) [Internet]. Available from: http://ansm.sante.fr/Declarer-un-effet-indesirable/Pharmacodependance-Addictovigilance/Pharmacodependance-Addictovigilance/%28offset%29/0. Accessed 12 June 2016.
18. Jouanjus E, Lapeyre-Mestre M, Micallef J, French Association of the Regional Abuse and Dependence Monitoring Centres (CEIP-A) Working Group on Cannabis Complications. Cannabis use: signal of increasing risk of serious cardiovascular disorders. J Am Heart Assoc. 2014;3(2):e000638.
19. Jouanjus E, Gibaja V, Kahn J-P, Haramburu F, Daveluy A. Signal identification in addictovigilance: the functioning of the French system. Thérapie. 2015;70(2):113–31.
20. Bate A, Evans SJW. Quantitative signal detection using spontaneous ADR reporting. Pharmacoepidemiol Drug Saf. 2009;18(6):427–36.
21. Montastruc J-L, Sommet A, Bagheri H, Lapeyre-Mestre M. Benefits and strengths of the disproportionality analysis for identification of adverse drug reactions in a pharmacovigilance database. Br J Clin Pharmacol. 2011;72(6):905–8.
22. Montastruc G, Favreliere S, Sommet A, Pathak A, Lapeyre-Mestre M, Perault-Pochat M-C, et al. Drugs and dilated cardiomyopathies: a case/noncase study in the French PharmacoVigilance Database. Br J Clin Pharmacol. 2010;69(3):287–94.
23. Martinez V, Attal N, Bouhassira D, Lantéri-Minet M. Les douleurs neuropathiques chroniques: diagnostic, évaluation et traitement en médecine ambulatoire. Recommandations pour la pratique clinique de la Société française d’étude et de traitement de la douleur. Douleurs Eval Diagn Trait. 2010;11(1):3–21.
24. Rothman KJ, Lanes S, Sacks ST. The reporting odds ratio and its advantages over the proportional reporting ratio. Pharmacoepidemiol Drug Saf. 2004;13(8):519–23.
25. McNamara S, Stokes S, Kilduff R, Shine A. Pregabalin abuse amongst opioid substitution treatment patients. Ir Med J. 2015;108(10):309–10.
26. Schjerning O, Rosenzweig M, Pottegård A, Damkier P, Nielsen J. Abuse potential of pregabalin: a systematic review. CNS Drugs. 2016;30(1):9–25.
27. Millar J, Sadasivan S, Weatherup N, Lutton S. Lyrica nights–recreational pregabalin abuse in an Urban Emergency Department. Emerg Med J. 2013;30(10):874.
28. Baird CRW, Fox P, Colvin LA. Gabapentinoid abuse in order to potentiate the effect of methadone: a survey among substance misusers. Eur Addict Res. 2014;20(3):115–8.
29. European Medicines Agency (EMA). European Medicines Agency (EMA) Lyrica (pregabalin) Scientific Discussion. [Internet]. Disponible sur: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Scientific_Discussion/human/000546/WC500046600.pdf. Accessed 13 June 2016.
30. Schifano F, D’Offizi S, Piccione M, Corazza O, Deluca P, Davey Z, et al. Is there a recreational misuse potential for pregabalin? Analysis of anecdotal online reports in comparison with related gabapentin and clonazepam data. Psychother Psychosom. 2011;80(2):118–22.
31. ®)) help patients reduce their use of benzodiazepines? A comparison with gabapentin using the Norwegian Prescription Database. Basic Clin Pharmacol Toxicol. 2010;107(5):883–6.
32. Pauly V, Lapeyre-Mestre M, Braunstein D, Rueter M, Thirion X, Jouanjus E, et al. Detection of signals of abuse and dependence applying disproportionality analysis. Eur J Clin Pharmacol. 2015;71(2):229–36.
33. Beau-Salinas F, Jonville-Béra AP, Cissoko H, Bensouda-Grimaldi L, Autret-Leca E. Drug dependence associated with triptans and ergot derivatives: a case/non-case study. Eur J Clin Pharmacol. 2010;66(4):413–7.
34. Victorri-Vigneau C, Dailly E, Veyrac G, Jolliet P. Evidence of zolpidem abuse and dependence: results of the French Centre for Evaluation and Information on Pharmacodependence (CEIP) network survey. Br J Clin Pharmacol. 2007;64(2):198–209.
35. ®: Informations importantes sur le bon usage - Réduction du conditionnement des comprimés [Internet]. Available from: http://ansm.sante.fr/S-informer/Informations-de-securite-Lettres-aux-professionnels-de-sante/Informations-importantes-sur-le-bon-usage-du-RIVOTRIL-R-et-sur-la-reduction-du-conditionnement-des-comprimes. Accessed 12 June 2016.
36. Expériences - Lyrica [Internet]. PsychoActif. 2015 Available from: https://www.psychoactif.org/forum/t13178-p1-Lyrica.html#divx. Accessed 12 June 2016.
37. Pariente A, Didailler M, Avillach P, Miremont-Salamé G, Fourrier-Reglat A, Haramburu F, et al. A potential competition bias in the detection of safety signals from spontaneous reporting databases. Pharmacoepidemiol Drug Saf. 2010;19(11):1166–71.
38. Driot D, Dupouy J, Palmaro A, Jouanjus E, Lapeyre-Mestre M. Pregabalin abuse in France: resulst of a national retrospective and comparative cohort study. Fundam Clin Pharmacol. 2016;30:40.