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Variation in make-up of generic epilepsy drugs can lead to dosing problems
Date:6/30/2011

al dose" drugs that have a high potential for over- or underdosing, the window could be significantly narrower.

After securing bioequivalency data for 141 generic epilepsy drugs from the FDA using Freedom of Information Act requests, Krauss and his colleagues found that peak blood concentration and total amount absorbed differed by less than 15 percent between the vast majority of generics and their brand-name equivalents. However, some manufacturers had generic products that were at the upper or lower edge of the acceptance limits, and these drugs varied markedly between each other compared to the brand-name drugs-as much as 30 percent between generic formulations for one drug in particular, oxycarbazepine.

Since each brand-name drug can have many different generic counterparts - and pharmacies frequently switch between different generic versions - prescriptions for some generic drugs could prove unsafe for epilepsy patients, Krauss notes.

"Overall, generics should be used for treating epilepsy," Krauss says. "However, we suggest that patients and pharmacies should be cautious when switching between different generic version of anticonvulsants, and policy makers should evaluate whether standards that set the range for generics' similarity to brand name versions are appropriate for every drug. For patients with epilepsy, that may not be the case."

He notes that for other pharmaceuticals in which over- or underdosing by narrow margins may also be a problem, such as chemotherapeutics for cancer, the same questions can be raised.


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Contact: Christen Brownlee
cbrownlee@jhmi.edu
410-955-7832
Johns Hopkins Medical Institutions
Source:Eurekalert

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