Risks and Benefits of Generic Antiepileptic Drugs

Abstract

In order to obtain scientific evidence on the potential risks and benefits of interchanging branded and generic antiepileptic drugs, high methodological comparative studies are necessary. These studies could bring consensus about the role of generic drugs for treating epilepsy.

Generic Substitution of Antiepileptics: Need for a Balanced View

“…As a result, there is still significant uncertainty and ongoing debate about the role of generic brands of drugs for treating epilepsy. [1][2][3][4][11][12][13][14][15] The FDA includes phenytoin, carbamazepine, and valproate as narrow therapeutic index medicines, although the argument that AEDs have a narrow therapeutic index is not widely accepted, except in the case of phenytoin. 12,13…”

“…People with well-controlled epilepsy may be most vulnerable, because a single seizure could jeopardise driving privileges or work. 1,11,[14][15][16][17][18] Much more is at stake than with the generic brand substitution of antibiotics.…”

“…A systematic review of the literature on generic AEDs was also performed by Gomez-Alonso and colleagues. 11 They reported that published studies are usually of a descriptive nature and are sometimes based on generic drugs that were approved during times when regulatory agency requirements were not as strict as they are now. In addition, the available literature indicated a certain bias toward publishing cases in which changing products had apparently negative results.…”

“…By contrast, finding the percentage of patients in whom medications were successfully changed, with no clinical consequences of any kind, was difficult. 11 Kesselheim and colleagues 34 reviewed 9 randomized controlled trials, one prospective nonrandomized trial, and 6 observational studies that compared seizure events or seizure-related outcomes flowing switching between a brand-name AED and an alternative version produced by a distinct manufacturer. 34 It was concluded that, while most randomized controlled trials were short-term evaluations, the available evidence did not suggest an association between loss of seizure control and generic substitution of at least three types of AEDs.…”

Comparative Plasma Exposure and Lung Distribution of Two Human Use Commercial Azithromycin Formulations Assessed in Murine Model: A Preclinical Study

“…Around the world, the replacement is promoted in some case of disease when the generic drugs are bioequivalent with his respective innovator drugs [3, 4]. However, therapeutic failure and adverse effects in the use of generic drugs in humans in specific diseases like antiepileptic drugs have been reported [4, 5]. …”