US FDA warns that zonisamide increases risk of metabolic acidosis

2 March 2009

US regulators have issued a warning on Japanese drugmaker Eisai's off-patent anti-epileptic Zonegran (zonisamide) after recent data showed  that the drug increased levels of acid in the blood.

Following a review of updated clinical data, the US Food and Drug  Administration determined that zonisamide can cause metabolic acidosis  in some patients.

Generic versions of the agent are made by Teva, Novartis' Sandoz unit,  Mylan and Watson Pharmaceuticals, as well as by its developer Eisai. The  drug is indicated as adjunctive therapy for partial seizures in adults  with epilepsy.

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