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01-01-2013 | Original Research Article

Adverse Drug Reactions to Gabapentin and Pregabalin

A Review of the French Pharmacovigilance Database

Authors: Régis Fuzier, Isabelle Serres, Emmanuelle Guitton, Maryse Lapeyre-Mestre, Jean-Louis Montastruc, The French Network of Pharmacovigilance Centres

Published in: Drug Safety | Issue 1/2013

Abstract

Background

Gabapentin and pregabalin are widely used as antineuropathic pain drugs. Their use is also associated with the development of adverse drug reactions (ADRs), mainly neuropsychiatric.

Objective

The aim of this work was to study ‘serious’ and/or ‘unexpected’ adverse reactions associated with pregabalin and gabapentin.

Study Design

We studied ADRs reported to the French Pharmacovigilance System occurring between 1995 and 2009.

Main Outcome Measure

For each ADR associated with gabapentin or pregabalin, we noted year, patient age and sex, type of adverse reaction, as well as the imputability score. Reporting rate of serious ADRs for gabapentin and pregabalin was estimated with regard to data of use (obtained from the French National Health Insurance Fund) using the defined daily dose. A global and descriptive analysis of the adverse reactions for each drug is presented. Secondly, details of deaths and ADRs with an imputability score of at least ‘probable’ or ‘likely’ were presented.

Results

Overall, 1333 cases were recorded (725 related to gabapentin, 608 related to pregabalin), mainly neuropsychiatric ADRs. Among the 22 deaths recorded, 8 were related to gabapentin in obstetrical situations. Other less well-documented ADRs were identified, such as hepatitis associated with gabapentin and haematological ADRs associated with pregabalin.

Conclusion

This study confirmed the prevalence of neuropsychiatric ADRs associated with gabapentin or pregabalin. A high rate of death occurred with gabapentin in an obstetrical context. New adverse reactions have been noted, such as haematological or hepatic adverse reactions associated with pregabalin and gabapentin, respectively.

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Title: Adverse Drug Reactions to Gabapentin and Pregabalin
A Review of the French Pharmacovigilance Database
Authors: Régis Fuzier
Isabelle Serres
Emmanuelle Guitton
Maryse Lapeyre-Mestre
Jean-Louis Montastruc
The French Network of Pharmacovigilance Centres
Publication date: 01-01-2013
Publisher: Springer International Publishing AG
Published in: Drug Safety / Issue 1/2013
Print ISSN: 0114-5916
Electronic ISSN: 1179-1942
DOI: https://doi.org/10.1007/s40264-012-0006-6

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Adverse Drug Reactions to Gabapentin and Pregabalin

A Review of the French Pharmacovigilance Database

Abstract

Background

Objective

Study Design

Main Outcome Measure

Results

Conclusion

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Objective

Study Design

Main Outcome Measure

Results

Conclusion

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