Warnings Issued for Women Taking Valproate-Containing Migraine and Antiepileptic Drugs During Pregnancy

The Food and Drug Administration (FDA) issued an alert to health care providers and patients that medications including and related to valproate sodium taken during pregnancy were correlated with lower IQ scores in those children. As a result, the drugs are contraindicated (should never be used) for pregnant women to treat migraine headaches. Valproate can be found in both branded and generic drug products.

Currently the valproate products are FDA-approved for prevention of migraine headaches; treatment of epilepsy; and treatment of manic episodes associated with bipolar disorder. They are also used off-label (for unapproved uses) for other conditions, particularly for other psychiatric conditions.

For its other approved uses — bipolar disorder and seizures — valproate has potential value in pregnant women, but according to the agency, these valproate-containing medicines should only be considered if other medications have not controlled the symptoms or are otherwise unacceptable. Additionally, the FDA noted that women who can become pregnant should not use valproate unless it is essential to managing their medical condition.

In 2011, the FDA updated valproate-containing medicine labels to include a boxed warning indicating fetal risk, including birth defects. The safety alert is in response to a recently published Neurodevelopmental Effects of Antiepileptic Drugs (NEAD) study (abstract) that found further evidence of the IQ risk. The study bolsters other studies that found a negative effect of valproate on children’s IQ.

In the NEAD study, it was observed that children exposed to valproate products in utero had decreased IQ scores at age 6 compared to children exposed to other antiepileptic drugs. This decrease ranged from between 8 to 11 points.

The FDA alert also noted that it is not known at what point during a pregnancy valproate exposure could result in decreased IQ, because the women in the NEAD study were exposed to antiepileptic drugs throughout their pregnancies.