FDA issues zonisamide warning

The FDA has reviewed updated clinical data to determine that treatment with zonisamide can cause metabolic acidosis in some patients. Patients with predisposing conditions or therapies may be at greater risk and the risk of zonisamide-induced metabolic acidosis appears to be more frequent and severe in younger patients. The FDA is recommending that healthcare professionals measure serum bicarbonate levels before and during treatment with zonisamide, even in the absence of symptoms.  The agency is also working with manufacturers of zonisamide to revise the product labeling to reflect this new safety information.

Zonisamide is indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy.

For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm106934.htm.