Pregnant women warned to avoid Depakote, Depacon and Depakene for migraines: Can cause decreased IQ in children
The U.S. Food and Drug Administration (FDA) is warning physicians, other health care providers and pregnant women to avoid medications containing valproate products as this can cause lower IQ scores in children of mothers who used them during pregnancy, according to an FDA news release today.
Image/James Gathany
Valproate products are approved in the treatment of epilepsy (seizures), prevention of migraine headaches and treatment of manic episodes associated with bipolar disorder (manic-depressive disorder).
Examples of drugs containing valproate include valproate sodium (Depacon), divalproex sodium (Depakote, Depakote CP, and Depakote ER), valproic acid (Depakene and Stavzor), and their generics. These these drugs are being contraindicated for (should never be used by) pregnant women for the prevention of migraine headaches.
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.
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 its other approved uses — bipolar disorder and seizures — valproate may have some value in pregnant women, but it should only be taken if other medications have not controlled the symptoms or are otherwise unacceptable. Women who can become pregnant should not use valproate unless it is essential to managing their medical condition.
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