May 6 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
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
"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