Antiseizure medication valproate sodium and other products of the valproic acid lineage should not be administered or taken by pregnant women, the FDA warned in a recent announcement.
In the release, the FDA advised physicians and healthcare professionals at large to only prescribe such products if there is no other viable option available for pregnant epileptic or bipolar patients.
“Based on information from a recent study, there is evidence that these medications can cause decreased IQ scores in children whose mothers took them while pregnant,” the warning declared. “Stronger warnings about use during pregnancy will be added to the drug labels, and valproate’s pregnancy category for migraine use will be changed from "D" (the potential benefit of the drug in pregnant women may be acceptable despite its potential risks) to "X" (the risk of use in pregnant women clearly outweighs any possible benefit of the drug).”
Although the FDA first alerted of the possible adverse effects valproate sodium posed for pregnant women in a June 2011 Drug Safety Communication, concerns were cemented with the conclusion of the Neurodevelopmental Effects of Antiepileptic Drugs (NEAD) study. The NEAD report results revealed decreased IQs in children who had been exposed to valproate products via their mothers during pregnancy compared to children whose mothers had used other anti-epileptic drugs.
“The difference in average IQ between the children who had been exposed to valproate and the children who had been exposed to other antiepileptic drugs varied between 8 and 11 points depending on the drug to which valproate was compared,” the FDA release noted.
“It is not known whether there is a specific time period during pregnancy when valproate exposure can result in negative cognitive effects,” the organization concluded. “Similarly, there is no known time during pregnancy in which exposure may be considered to have less risk for decreased IQ in children. Because the women in the NEAD study were exposed to antiepileptic drugs throughout pregnancy, whether the risk for decreased IQ was related to a particular time period during pregnancy could not be assessed.”
Currently, the FDA is working with manufacturers to amend drug labels for valproate products to reflect the latest risk information.
Find more information about valproate products and the FDA bulletin here.