The U.S. Food and Drug Administration warned on the use of migraine drug valproate sodium in pregnant women as it could result in lower IQ scores in the baby.
The FDA said the results of a recent study showed that children exposed to valproate products in the womb had lower IQ at the age of six than children who were exposed to other antiepileptics.
Drugs containing valproate are used to prevent migraine headaches, treat epileptic seizures and manic episodes associated with bipolar disorder.
Abbott Laboratories’ Depacon, Depakote, Depakote CP, Depakote ER and Depakene, and Noven Therapeutics LLC’s Stavzor and their generics contain valproate.
Drugs containing valproate already carry a boxed warning for birth defects.
“Valproate medications should never be used in pregnant women for the prevention of migraine headaches because we have even more data now that shows the risks to the children outweigh any treatment benefits for this use,” FDA’s Director of the Division of Neurology Products, Russell Katz said.
This is the second time the FDA has warned on drugs containing valproate. In a June 2011 press release, the regulator had issued interim results of a study showing reduced cognitive functions in three-year-old children exposed to valproate.
(Reporting By Pallavi Ail in Bangalore; Editing by Roshni Menon)