The Food and Drug Administration issued a warning to pregnant women Monday about taking medication that includes valproate sodium. The FDA warning said that lowered IQ scores resulted in children whose mothers took valproate sodium during pregnancy.
Several FDA-approved valproate medications are taken to treat migraine headaches, epileptic seizures and manic episodes associated with bipolar disorder. Valporate products include valporate 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," Director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research, Dr. Russell Katz said in a press release.
The FDA said that pregnant women should only use valproate products as a last resort, only if other medications don't work. Valproate medications currently already have a boxed warning label to advise women about the risk of birth defects. Following the preliminary results from a study in 2011, Neurodevelopmental Effects of Antiepileptic Drugs (NEAD), the FDA issued an alert. The study showed reduced cognitive test scores in 3-year-olds who were exposed to valproate.
The final results of the NEAD study found that children exposed to the drugs as a fetus had a low IQ at age 6 compared to children who were exposed to other antiepileptic drugs. Between the children who had been exposed to valproate and the children who had been exposed to other antiepileptic drugs, the average IQ difference varied between 8 to11 points.
The FDA is working with manufacturers to update drug labels to include this information; valprorate will remain categorized as a category D drug in the pregnancy category, in which the drug benefits outweigh the risks. Changes will be made to the pregnancy category for prevention and treatment of migraine headaches to category X, indicating that the risks of using of the drug outweigh the benefits.