(RxWiki News) The FDA has issued a safety alert regarding valproate sodium drugs (Depacon, Depakote, Depakote CP, Depakote ER, Depakene, Stavzor, and their generics) taken during pregnancy.
The FDA believes offspring of mothers who take valproate sodium drugs may score lower on IQ tests than children born to women who take different anti-seizure medications.
Valproate sodium products are approved by the U.S. Food and Drug Administration (FDA) for the treatment of seizures, bipolar disorder and migraine headaches. They are also commonly prescribed off-label for the treatment of psychiatric conditions.
"Ask your OB/GYN if taking Depakote is ok."
The FDA has advised doctors that the benefits and risks of Depakote and similar medications should be carefully weighed when prescribing to women of childbearing age, particularly for conditions not usually associated with permanent injury or death. If the use of Depakote is not essential, alternative medications should be prescribed.
Women of childbearing age on a valproate sodium medication should use birth control, according to the FDA. The American College of Obstetricians and Gynecologists reports that the most effective forms of birth control are IUDs and implants.
These findings are based on cognitive tests performed on three-year-old children whose mothers took valproate sodium while pregnant. The results were compared and contrasted with results from tests performed on three-year-old children whose mothers took different anti-seizure medications during pregnancy.
The children whose mothers were on alternative seizure drugs scored significantly higher on cognitive tests. In other studies, tests were performed at ages five through 16. Cognitive tests assess development in areas including intelligence, reasoning and problem solving.
The long-term effects on cognitive development from exposure to valproate sodium products during pregnancy are still unknown. It is also not known at what point during the pregnancy that cognitive impairments occur.
