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Adverse Drug Reactions to Gabapentin and Pregabalin

A Review of the French Pharmacovigilance Database

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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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Acknowledgements

The authors acknowledge the assistance of all 31 regional centres of the French Pharmacovigilance System. The authors would like to thank Dr Ian Harper, MD (Newcastle, UK), for his very helpful comments regarding the manuscript. No funding was provided for the conduct of the study and/or preparation of the article. There were no relevant conflicts of interest for all authors. All authors discussed the results and commented on the manuscript. R. Fuzier conceived and planned the work, and played an important role in the analysis and interpretation of the data. He wrote the paper. I. Serres played an important role in the acquisition, analysis and interpretation of the data. M. Lapeyre-Mestre and J.L. Montastruc provided substantial contributions to the conception and design, analysis and interpretation of data, revising the manuscript critically for important intellectual content. All authors approved the final submitted version of the manuscript. E. Guitton made substantive suggestions for revision.

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Authors and Affiliations

  1. Pharmacoepidemiology Research Unit, INSERM 1027, University of Toulouse, Toulouse, France

    Régis Fuzier, Isabelle Serres, Emmanuelle Guitton & Jean-Louis Montastruc

  2. Department of Clinical Pharmacology, Pharmacovigilance Regional Centre of Midi-Pyrénées, Toulouse University Hospital, Toulouse, France

    Emmanuelle Guitton, Maryse Lapeyre-Mestre & Jean-Louis Montastruc

  3. Department of Clinical Pharmacology, Toulouse University Hospital, 37 Allées Jules Guesde, 31073, Toulouse, CEDEX, France

    Régis Fuzier

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  1. Régis Fuzier
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The French Network of Pharmacovigilance Centres

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Correspondence to Régis Fuzier.

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Fuzier, R., Serres, I., Guitton, E. et al. Adverse Drug Reactions to Gabapentin and Pregabalin. Drug Saf 36, 55–62 (2013). https://doi.org/10.1007/s40264-012-0006-6

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