FDA warns pregnant women to not use certain migraine prevention medicines
Valproate products can lower IQ scores in children of mothers who used them during pregnancy
The U.S. Food and Drug Administration is alerting health care providers and patients that medications including and related to valproate sodium can cause decreased IQ scores in children whose mothers took the medication during pregnancy. Therefore, these drugs are being contraindicated for (should never be used by) pregnant women for the prevention of migraine headaches. Valproate products include valproate sodium (Depacon), divalproex sodium (Depakote, Depakote CP, and Depakote ER), valproic acid (Depakene and Stavzor), and their generics.
Valproate products 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 today’s strengthened warnings.
Women who are pregnant, or who become pregnant while taking one of these medications, should talk to their health care professional immediately. Women shouldnot stop taking their medication without talking to their health care professional because stopping treatment suddenly can cause serious and life-threatening medical problems for the woman or the developing fetus. Women of childbearing age taking valproate products should use effective birth control.
It is not known if there is a certain time period during pregnancy when valproate exposure can result in decreased IQ. The women in the NEAD study were exposed to antiepileptic drugs throughout their pregnancies.
The FDA’s strengthened recommendations are based on the final results of the NEAD study, which showed that children exposed to valproate products in utero had decreased IQ at age 6 when compared to children who were exposed to other antiepileptic drugs. The difference in average IQ between the children who had been exposed to valproate and the children who had been exposed to other antiepileptic drugs varied between 8 and 11 points depending on the antiepileptic drug.
For additional information:
· North American Antiepileptic Drug Pregnancy Registry