US FDA warns pregnant women to not use valproate migraine prevention medicines

The US Food and Drug Administration is alerting health care providers and patients that medications including and related to valproate sodium, an epilepsy treatment, can cause decreased IQ scores in children whose mothers took the drugs during pregnancy.

Therefore, says the FDA, these drugs are being contraindicated for pregnant women for the prevention of migraine headaches. Valproate products include valproate sodium (Depacon), divalproex sodium (Depakote, Depakote CP and Depakote ER, from Abbott Labs)), valproic acid (Depakene from Sanofi) and Stavzor (from Noven Pharmaceuticals), and their generics.

Valproate products, now off patent, have several FDA-approved uses including: prevention of migraine headaches; treatment of epilepsy (seizures); and treatment of manic episodes associated with bipolar disorder (manic-depressive disorder). Medicines that contain valproate already have a boxed warning for fetal risk, including birth defects. The recently published Neurodevelopmental Effects of Antiepileptic Drugs (NEAD) study found further evidence of the IQ risk, leading to this strengthened warnings.