July 1, 2011
Recent epidemiological studies show that children born to mothers taking valproate products (ie, valproic acid, valproate sodium, or divalproex sodium) while pregnant performed worse on cognitive tests compared to children whose mothers were taking other anticonvulsant medications. The primary study tested children at 3 years of age and additional studies tested children 5 to 16 years of age in several areas of mental development, including abstract reasoning, problem solving, and intelligence. Long-term effects on cognition are unknown. FDA is updating the Warning and Precautions section in valproate product labels and Medication Guides to include this risk. Valproate products are labeled to treat seizure disorders and bipolar disorders. They are also used as migraine prophylaxis.
Instruct patients not to stop taking valproate products without talking to a healthcare provider. Counsel women of childbearing age about the risk of impaired cognitive development in children exposed to valproate products in utero. Continue to counsel women about the risk of neural tube defects and other malformations associated with valproate products. Assess the risk versus benefit before prescribing these medications to women of childbearing age and consider alternative medications with lower risk of adverse events. Report adverse events to FDA MedWatch Safety Information and Adverse Event Reporting Program.
Additional information is available at the following links:
- MedWatch alert:
- Drug Safety Communication:
July 1, 2011; University of Utah, Drug Information Service. Copyright 2011, Drug Information Service, University of Utah, Salt Lake City, UT.