drugs information
Depakote Black Box Warning
Market Name: Depakote / Depacon / Depakene
Generic Name: Valproic acid / valproate sodium / divalproex sodium
Depakote tablets are indicated for the treatment of bipolar disorder, epilepsy and migraine headaches. Studies have revealed that Depakote increases the risk of pancreatitis, possible fetal injury (including spina bifida), and liver problems. Children under the age of 2 are at a particularly high risk for liver problems, especially those on multiple anticonvulsants, those with congenital metabolic disorders, those with severe seizure disorders accompanied by mental retardation, and those with organic brain disease.
A black box warning was added to Depakote's labeling by the FDA in January of 2006.
Black Box Warning Date: January 2006