Depakote Carries Significant Fetal Risks

FDA_depakote_warningDepakote, Depakene, Depacon and other products containing valproate are used to treat seizures, migraines and occasionally bipolar disorder. If taken by a pregnant woman, however, these drugs can lead to a number of birth defects. Throughout the years the U.S. Food and Drug Administration (FDA) has updated the label on Depakote and other valproate drugs to warn about the risk of certain birth defects. Recently, the agency added a boxed label to the drug. A boxed warning is the most serious warning available for a medication.

According to the FDA’s website, the boxed warning states that Depakote can cause lower IQ scores and major congenital malformations, especially neural tube defects such as spina bifida. Spina bifida is when the spinal cord fails to close properly. It can lead to defects in the spinal cord and backbones. The warning advises against using Depakote to treat migraines in pregnant women.

Evidence has linked Depakote and other valproate drugs to birth defects throughout the years. In May 2007, doctors began to report a higher risk of mental deficits in children whose mothers took Depakote to treat their epilepsy. In June 2010, the New England Journal of Medicine published a study showing that Depakote was linked to the following defects:

  • Cleft palate
  • Polydactyly (extra fingers or toes)
  • Craniosyntosis
  • Spina bifida
  • Atrial Septal defect (hole in the heart)
  • Hypospadias (abnormal opening in a boy’s urethra)

The FDA first updated the label on valproate products in 2009, warning that these drugs had a higher risk of neural tube defects, craniofacial defects, cardiovascular malformations and other complications. In May, the agency also modified the label to warn that pregnant women should not take Depakote for migraine treatment because of the risk of lower IQ scores.

Congenital malformations are four times higher in babies whose mothers used valproate compared to mothers who used other seizure medications, the FDA states. Taking folic acid before pregnancy and during the first trimester might decrease this risk may decrease the risk of neural tube defects. The warning and precautions section of valproate cites a large study showing that children who were exposed to the antiepileptic drugs in utero had lower IQ scores at age 6 compared to those whose mothers used another seizure medication.

Given the mounting evidence, the FDA has stated that Depakote and other valproate medications should not be used by pregnant women to treat epilepsy unless all other options are inadequate.

This entry was posted in Legal News. Bookmark the permalink.

© 2005-2016 Parker Waichman LLP ®. All Rights Reserved.