FDA Warns against Use of Valproate by Pregnant Women

The U.S. Food and Drug Agency has warned mothers-to-be against using certain medication for migraines.

The agency said that using valproate sodium during pregnancy can lower IQ in children. The migraine headache-relieving products include valproate sodium (Depacon), divalproex sodium (Depakote, Depakote CP, and Depakote ER), valproic acid (Depakene and Stavzor), and their generics.

"Valproate medications should never be used in pregnant women for the prevention of migraine headaches because we have even more data now that show the risks to the children outweigh any treatment benefits for this use," said Russell Katz, M.D., director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research in a news release.

Previous studies have shown that exposure to antiepileptic drugs in the womb can lead to development of autism and other neurological disorders. Apart from migraine headache, valproate is also used to relieve symptoms of epilepsy (seizure).

The agency's recommendations are based on the NEAD study which had found that exposure to valproate in the womb was linked with decreased IQ at age 6 when compared with children who had been exposed to other types of antiepileptic drugs. FDA had earlier (in 2011) issued an alert about the use of the drug by pregnant women and its association with lower cognitive skills among their children.

Pregnant women should consult their healthcare provider about the drug and use it only when no other medication is useful, the agency said. Also, women taking the drugs should use effective birth control.