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U.S. Department of Health and Human Services

Safety

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Depakote / Depakene / Depacon (divalproex sodium / valproic acid / valproate sodium)

Audience: Neuropsychiatric healthcare professionals

FDA and Abbott strengthened the CONTRAINDICATIONS, WARNINGS and PRECAUTIONS sections of the label for Depakote Tablets, Depakote ER Tablets, Depakote Sprinkle Capsules, Depakene Capsules and Syrup and Depacon for Injection. Healthcare professionals were informed that hyperammonemic encephalopathy, sometimes fatal, has been reported following initiation of valproate therapy in patients with urea cycle disorders [UCD], a group of uncommon genetic abnormalities. Patient criteria to consider in evaluation for UCD prior to initiation of valproate therapy are offered.

[June, 2002 - Letter - Abbott]