[Skip to Content]
[Skip to Content Landing]
Views 1,246
Citations 0
August 2017

Potential Influence of FDA-Sponsored Studies of Antiepilepsy Drugs on Generic and Brand-name Formulation Prescribing

Author Affiliations
  • 1Department of Neurology, Johns Hopkins University, Baltimore, Maryland
JAMA Neurol. 2017;74(8):900-901. doi:10.1001/jamaneurol.2017.0492

Patients with epilepsy frequently ask to be prescribed “brand-name only” antiepileptic drugs (AEDs) out of concern they will have disabling seizures or adverse drug effects if they take generic formulations. The cost differences between the reference-listed products and generic products, however, are dramatic. For example, generic oxcarbazepine 600-mg tablets cost $0.90 each, while brand-name Trileptal (Novartis) tablets are $14.81 and the often-better-tolerated prodrug eslicarbazepine acetate costs $29.67 per tablet.1 Costs of AEDs in the United States decreased by more than $5 billion between 2006 and 2010 as generic formulations of second-generation AEDs were released, highlighting the cost benefits of generic AEDs.2 So how are clinicians to balance patient concerns with assurances from the US Food and Drug Administration (FDA) of generic quality? Canada addressed this problem by requiring patients to first try generic tablets; if patients develop seizures or do not tolerate generic formulations, then they can be switched to the more expensive brand-name treatments. Surprisingly, 20% to 44% of patients switch back from generic AEDs to brand-name AEDs,3 a much higher proportion than that seen with other treatment classes.

First Page Preview View Large
First page PDF preview
First page PDF preview