FDA Warns Women Against Some Migraine Drugs During Pregnancy
(WASHINGTON) -- The U.S. Food and Drug Administration is warning expectant mothers not to take a set of drugs used commonly as a treatment for migraines. The medication is said to be linked to lower IQ scores in children whose mothers took it during pregnancy.
The FDA says valproate products, or valproate sodium (Depacon), divalproex sodium (Depakote, Depakote CP and Depakote ER), valproic acid (Depakene and Stavzor) and their generics are approved for migraine headache prevention, treatment of epilepsy (seizures) and for bipolar disorder. Though labels on these products already warn about fetal risk, new research has prompted a stronger message.
The recently published study, called "Neurodevelopmental Effects of Antiepileptic Drugs," led the FDA to warn pregnant women never to use these medicines for migraine prevention after finding further evidence of IQ risk.
"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 Dr. Russell Katz, director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research.
However, the FDA says the products may still be effective in treating pregnant women for the drugs' other approved uses -- bipolar disorder and seizures. If taken only when other medications "have not controlled the symptoms, or are otherwise unacceptable," the agency says valproate may still have value in pregnant women.
Women should talk to their health care providers for more information about what medications are safe to take during pregnancy.
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