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

Abstract

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.

Association of Stevens‐Johnson syndrome and toxic epidermal necrolysis with antiepileptic drugs in pediatric patients: Subgroup analysis based on a Japanese spontaneous database

“…First, there was no certainty that the reported event was actually due to the drug because confounding by concomitant medications and comorbidities is likely. Second, it is possible that the data involve a reporting bias, including the underreporting of adverse events, which is an inherent limitation of a voluntary reporting system like JADER and other pharmacovigilance databases …”

“…Second, it is possible that the data involve a reporting bias, including the underreporting of adverse events, which is an inherent limitation of a voluntary reporting system like JADER 22 and other pharmacovigilance databases. 23,24…”

Pregabalin induced visual hallucinations – a rare adverse reaction

“…Pregabalin as a medication can cause dependence, which on some occasions can lead to abuse [20]. Norgaard et al, reported a 38 year-old man who was abusing pregabalin by self-administering 8.4 g of pregabalin daily and after 36 h of pregabalin discontinuation, he reported auditory hallucinations and suicidal ideation with associated sweating and tachycardia.…”

Gabapentin and Pregabalin for the Treatment of Anxiety Disorders

“…41,42 Opiate users prescribed gabapentin reportedly had a higher risk of opiate-related mortality compared to those not prescribed gabapentin. 43 In one pharmacovigilance database review, the incidence of pregabalin dependence per new prescription was lower than that of the benzodiazepine clonazepam, 44 which is a Schedule IV controlled substance in the United States (indicating greater abuse potential than Schedule V). In a laboratory study of a small number of non-drug-abusing volunteers, daily administration of therapeutic doses of pregabalin did not produce subjective effects suggesting abuse liability.…”