Risks During Pregnancy

Depakote is a brand name for a medicine containing valproate (including divalproex sodium). Exposure during pregnancy is associated with serious risks to the developing child.

Birth Defects

• Neural tube defects: Prenatal exposure is associated with an increased risk of defects such as spina bifida. The earlier summary described an increase of up to twelvefold.
• Other malformations: Reported risks include heart defects, limb abnormalities, and cleft lip or palate.

Cognitive and Developmental Effects

• Cognitive development: Studies have associated prenatal valproate exposure with lower average IQ scores. The earlier summary cited a difference of approximately nine points.
• Autism: An increased risk of autism spectrum disorder has been reported. The earlier summary cited figures of up to 9% compared with a baseline of approximately 1.5%.

Fetal Valproate Spectrum Disorder

The term fetal valproate spectrum disorder (FVSD) describes a range of possible effects associated with prenatal valproate exposure, including characteristic facial features, congenital malformations, and developmental difficulties.

Precautions

Because of these risks, valproate use during pregnancy and in people who may become pregnant requires specialist assessment and careful planning. The original summary highlighted discussion of alternative medicines, contraception, folic acid, and enhanced prenatal monitoring.