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Summary
Generic substitution of antiepileptic drugs remains a controversial area without a clear consensus to guide clinicians. The US Food and Drug Administration (FDA) requires rigorous testing of generic products and states that all approved products are interchangeable. FDA studies involve single doses in normal subjects so may not represent the performance of generic products in people with epilepsy. Physician surveys, case reports, and retrospective pharmacy database analyses suggest that antiepileptic drug generic substitution is associated with more health problems and high switchback rates, but these studies have insufficient detail on seizure control and blood levels. Several ongoing prospective randomized trials with rigorous pharmacokinetic methods aim to provide more data for decision-making.
- © 2013 American Academy of Neurology
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