Substitution of generic antiepileptic drugs

Despite the availability of generic antiepileptic drugs (AEDs), patients and neurologists still hesitate to make a switch due to several reasons.

The objectives of this review were to evaluate the risks associated with the generics substitution of AEDs. In this context, author Muhammad Atif and colleagues from the Islamia University of Bahawalpur, Pakistan, summarized the recommendations of various international societies to treat epileptic patients.

A number of electronic databases were used to identify the relevant published studies that demonstrated potential problems and recommendations regarding generics substitution of AEDs. Of 204 articles found, 153 were initially selected for additional review. Subsequently, 68 articles were finally selected.

Review of the articles found that potential problems linked with the generics substitution of AEDs could be bioequivalence issues, failure of drug therapy, emergence of adverse events, and increase in the frequency of seizures. Reasons for these problems could be the pharmacokinetic properties of AEDs and the unique characteristics of some epilepsy patients. Consequently, the generics substitution of AEDs may affect the successful treatment and quality of life of some patients.

Various guidelines recommend well-controlled epileptic patients to avoid switching from brand-name to generic drug products, from generic to brand-name drug products, or indeed between generics from different manufacturers. The reason for this is mainly due to the unavailability of bioequivalence data and the potential risk of losing control over seizures.

Abstracted by Muhammad Rehan Sarwar of the Department of Pharmacy, Faculty of Pharmacy and Alternative Medicine, The Islamia University of Bahawalpur, Bahawalpur, Punjab, Pakistan.

Conflict of Interest
The authors of the research paper [1] declared that there were no conflicts of interest.

Editor’s comment
Readers interested to learn more about bioequivalence of narrow therapeutic index drugs are invited to visit to view the following manuscript published in GaBI Journal:

Bioequivalence of narrow therapeutic index drugs and immunosuppressives

Readers interested in contributing a research or perspective paper to GaBI Journal – an independent, peer reviewed academic journal – please send us your submission here.

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1. Atif M, Azeem M, Sarwar MR. Potential problems and recommendations regarding substitution of generic antiepileptic drugs: a systematic review of literature. Springerplus. 2016;5:182.


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