The Food and Drug Administration is warning pregnant women not to use migraine drugs containing valproate sodium because they could lower the IQ’s of their unborn children.
The warning applies to several migraine medications, including Depacon, Depakote, Depakene, Stavzor and their generics. Drugs containing valproate are also used to treat epilepsy seizures and manic depressive episodes caused by bipolar disorder. Some doctors prescribe the drugs off label to treat psychiatric conditions.
“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 FDA’s Division of Neurology Products.
For its other approved uses — bipolar disorder and seizures — the FDA says valproate may have some value in pregnant women, but it should only be taken if other medications are not effective.
Medications containing valproate already warn of severe birth defects if used during pregnancy, as well as life-threatening damage to the liver and pancreas.
A recently published study on the neurodevelopmental effects of antiepileptic drugs (NEAD) found further evidence of the IQ risk caused by valproate, which prompted the FDA to strengthen its warnings. Children exposed to valproate during pregnancy had IQ scores that were 8 to 11 points lower at age 6 than children exposed to other anti-epileptic drugs.
It’s not known if there is a certain time frame during pregnancy when valproate exposure caused the lower IQ’s.
The FDA advised women taking valproate products to use birth control.
“Women who are pregnant, or who become pregnant while taking one of these medications, should talk to their health care professional immediately,” the FDA said in a statement. “Women should not stop taking their medication without talking to their health care professional because stopping treatment suddenly can cause serious and life-threatening medical problems for the woman or the developing fetus.”
In a 2011 alert, the FDA released interim results from the NEAD study that showed reduced cognitive test scores for children exposed to valproate during pregnancy.
Further information about the warning can be found in a drug safety communication the FDA released for health care professionals and patients.