Depakote Pregnancy Use Linked to Problems for Children as Preschoolers

A new study highlights the risks children exposed to Depakote in the womb may face, suggesting that children may be more likely to suffer developmental delays and other problems when compared to children exposed to the competing epilepsy drug Keppra.  

In a study published this month in the medical journal Neurology, researchers from the U.K. found that children whose mothers took Depakote while pregnant had inferior language and motor development as pre-schoolers when compared to children whose mothers took Keppra.

Researchers looked at the development levels of children between the ages of three and four and a half, testing them on language and mental development. The study found that the children of women who took levetiracetam, sold under the brand name Keppra showed no developmental difference from peers whose mothers took no epileptic drugs during pregnancy.

The children of mothers who took Depakote, however, scored 15.8 points lower on gross motor skill testing than those exposed to Keppra in the womb. They also scored 6.4 points on average below those same children when it came to comprehension language abilities and 9.5 points lower on expressive language abilities.

The researchers said this data should be used when deciding which antiepileptic drug women should take.

Depakote (valproic acid) was approved in the United States in 1978 for treatment of certain forms of epilepsy. However, Depakote pregnancy risks have been associated with the development of severe birth defects and malformations, including spina bifida, cleft palate, abnormal skull development, malformed limbs, holes in the heart and urinary tract problems; especially when the drug is taken during the first 28 days, when neural tube closure and other critical formations are taking place.

In 2006, the FDA added a “black box” warning about the potential risk of Depakote birth defects after a study found that 20% of pregnant mothers who gave birth while on Depakote had a child with malformations or a birth defect.

In May 2013, the FDA put new restrictions on Depakote pregnancy use, contraindicating it for pregnant women, but only when it was used for the treatment of migraines. The agency did not contraindicate it for pregnant women. The FDA changed all valproate-based drugs from a class “D” to a class “X” pregnancy drug, but only as they pertain to migraines.

Abbott Laboratories, the makers of Depakote, currently faces a number of Depakote birth defect lawsuits filed by families throughout the country, which allege that the drug maker failed to adequately research the medication or warn consumers and the medical community about the risks associated with using the popular medication during pregnancy.