Lower IQ Scores Linked to Depakote during PregnancyJul 1, 2011 | Parker Waichman LLP
More evidence has emerged linking fetal exposure to Depakote and similar epilepsy drugs to problems in children. According to a Drug Safety Communication issued yesterday by the U.S. Food & Drug Administration (FDA), taking Depakote or similar valproate medications during pregnancy could impair a child's cognitive development.
Valproate drugs are approved to treat epilepsy, bipolar disorder and migraine headaches. In addition to Depakote, drugs in this class include Depakon, Depakene and Stavzor, as well as generic brands.
Even before yesterday's alert was issued, the FDA had already assigned Depakote and other valproate drugs to Pregnancy Category D, which means there is positive evidence of human fetal risk, but potential benefits may still warrant use of the drug in pregnant women. In 2009, the agency warned that they were associated with an increased risk of neural tube birth defects when used in pregnancy.
Yesterday, the FDA said recent epidemiological studies have found that fetal exposures to the drugs tended to correlate with lower scores on IQ and other cognitive tests. Information about these findings is being added to the “Warnings and Precautions section" and the "Use in Specific Populations: Pregnancy section," of the drugs' labels, as well as to the Medication Guides that are being developed for the valproate drug products.
The FDA said doctors should inform women of childbearing potential about these risks, and consider alternative therapies, especially if using valproate to treat migraines or other conditions not usually considered life-threatening.
Women of childbearing potential should only use valproate if it is essential to manage their medical condition. Those who are not actively planning a pregnancy should use effective contraception, as birth defect risks are particularly high during the first trimester, before many women know they are pregnant, the agency said.