FDA Safety Alert – Increased Warnings for Depakote Use During Pregnancy
The FDA released a MedWatch safety alert today to increase the warnings for valproate products, such as Depakote® (divalproex sodium), Depacon® (valproate sodium), Depakene® (valproic acid), Stavzor® (valproic acid), and their generics. Valproate products are approved for the treatment of epilepsy, manic episodes associated with bipolar disorder, and prevention of migraine headaches. However, today the FDA warned: “Valproate products should not be used in pregnant women for prevention of migraine headaches and should be used in pregnant women with epilepsy or bipolar disorder only if other treatments have failed to provide adequate symptom control or are otherwise unacceptable.”
Thus, valproate products are now contraindicated for migraine prevention during pregnancy, and the drug labels will be updated to increase the pregnancy category for migraine use from category “D” (the potential benefit of the drug in pregnant women may be acceptable despite its potential risks) to “X” (the risk of use in pregnant women clearly outweighs any possible benefit of the drug). Moreover, valproate products should not be used in pregnancy for the treatment of epilepsy or bipolar disorder, unless all other treatment options have failed.
The FDA warns that women should immediately contact their healthcare provider if they are pregnant and taking valproate products.