The Food and Drug Administration requires rigorous testing of generic formulations of antiepileptic drugs to assure bioequivalence to the brand product and asserts that all approved formulations are interchangeable. Physician surveys, case reports, and "switchback" rates from large-scale generic conversions imply that all generic formulations may not be equal to the brand drug for all patient groups. This review presents the current state of the data on bioequivalence and therapeutic equivalence and proposes a series of studies to better clarify the risks of generic formulation substitution in susceptible populations. Until such studies are completed, when switching to generic formulations, health-care providers and people with epilepsy would do well to proceed cautiously and understand the potential risks and benefits of substitution. Extra caution may be needed for patients at highest risk of seizure complications, such as the pregnant patient, patients with recurrent status epilepticus, or patients who have been seizure-free for long periods of time and are driving.

中文翻译：

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通用抗癫痫药：当前争议和未来方向。

美国食品药品监督管理局要求对抗癫痫药的通用制剂进行严格测试，以确保与该品牌产品具有生物等效性，并声称所有批准的制剂均可以互换。医师调查，病例报告和大规模仿制转换的“转回”率暗示着，对于所有患者组而言，所有仿制制剂可能都不等于品牌药物。这篇综述介绍了生物等效性和治疗等效性的数据现状，并提出了一系列研究，以更好地阐明易感人群中通用制剂替代的风险。在此类研究完成之前，当改用非专利药时，医疗保健提供者和癫痫患者最好还是谨慎进行，并了解替代的潜在风险和益处。