The Food and Drug Administration and Abbott Laboratories have strengthened the contraindications, warnings, and precautions sections of the label for divalproex sodium, valproic acid, and valproate sodium, marketed as Depakote tablets, Depakote ER tablets, Depakote sprinkle capsules, Depakene capsules and syrup, and Depacon for injection. Depakote ER is indicated for prophylaxis of migraine in adults. Letters were sent to health care professionals regarding reported cases, sometimes fatal, of hyperammonemic encephalopathy following initiation of valproate therapy in patients with urea cycle disorders, a group of uncommon genetic abnormalities. Patient criteria to consider in evaluation for UCD prior to initiation of valproate therapy are offered. Copies of the letter are available at http://www.fda.gov/medwatch/SAFETY/2002/depakote_deardoc.pdf.
COPYRIGHT 2002 International Medical News Group
COPYRIGHT 2002 Gale Group
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