FDA staff calls for more studies on Depakote's risks

06/22/2009 | Reuters

Additional studies must be done to prove that Abbott Laboratories' anti-seizure drug Depakote does not cause developmental delay in children, FDA staff members recommended. Employees issued a memo in light of six reports of delayed development, including two cases of autism, in children exposed to Depakote since its approval in 1983. Abbott said it will continue working with the agency "to further evaluate any risks related to anti-epileptic drugs, neurodevelopment and pregnancy."

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