Published: May 6, 2013
By Todd Neale , Senior Staff Writer, MedPage Today
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Neurology
FDA: Migraine Drugs Dangerous in Pregnancy
Published: May 6, 2013
By Todd Neale , Senior Staff Writer, MedPage Today
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Pregnant women should not use valproate sodium and related drugs to prevent migraine because of the potential for lower IQ scores in children exposed in the womb, the FDA warned.
The contraindication applies to valproate sodium (Depacon), divalproex sodium (Depakote, Depakote CP, and Depakote ER), valproic acid (Depakene and Stavzor), and all generic equivalents.
Each of the drug’s labels will be changed to reflect a change in the pregnancy category for migraine use from D (the possible benefits might outweigh the potential risks) to X (the risks clearly outweigh any potential benefits).
“Women who are pregnant, or who become pregnant while taking one of these medications, should talk to their healthcare professional immediately,” according to the FDA. “Women should not stop taking their medication without talking to their healthcare professional because stopping treatment suddenly can cause serious and life-threatening medical problems for the woman or the developing fetus.”
The medications already contained boxed warnings regarding use in women of childbearing potential, citing the possible risks of neural tube defects and other major congenital malformations in the fetus. The labels stated that use should be avoided in these women “unless the drug is essential to the management of her medical condition.”
The stronger warning issued today came on the heels of the final results of the Neurodevelopmental Effects of Antiepileptic Drugs (NEAD) study, which showed that children exposed to valproate and related drugs in utero had IQ scores that were 8 to 11 points lower at age 6 compared with children exposed to other anti-epileptic drugs.
That confirmed preliminary results that caused the FDA to modify the drugs’ labels in 2011 to include warnings about cognitive deficits.
The pregnancy category remains D for the other two uses of these drugs — to treat manic episodes associated with bipolar disorder and epilepsy.
“With regard to valproate use in pregnant women with epilepsy or bipolar disorder, valproate products should only be prescribed if other medications are not effective in treating the condition or are otherwise unacceptable,” the FDA stated.