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FDA Warns Against Use of Migraine Prevention Drugs in Pregnant Women

Maternal use of valproate may lower IQ scores in children (May 6)

The FDA 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 contraindicated for pregnant women for the prevention of migraine headaches.

Valproate products include valproate sodium (Depacon, AbbVie), divalproex sodium (Depakote, Depakote CP, and Depakote ER, Abbott Laboratories), valproic acid (Depakene, AbbVie; Stavzor, Noven Therapeutics), and their generics. These products have several FDA-approved uses, including the prevention of migraine headaches, the treatment of epilepsy, and the 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 drug’s IQ risk, leading to the FDA’s strengthened warnings.

“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, MD, director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research.

For its other approved uses — bipolar disorder and seizures — valproate may have some value in pregnant women, but it should be taken only if other medications have not controlled the symptoms or are otherwise unacceptable, the agency says. Women who can become pregnant should not use valproate unless it is essential to managing their medical condition.

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 a decreased IQ at age 6 compared with that of 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.

In a June 2011 alert, the FDA released interim results from the NEAD study, which showed reduced cognitive test scores in the valproate-exposed children at age 3, and the drug labels were updated at that time.

Source: FDA; May 6, 2013.

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