European Medicine Agency Warns of High Rate of Developmental Problems with Depakote (Valproate) During Pregnancy

Los Angeles, CAThe risk for malformations and developmental problems in children exposed to depakote (valproate semisodium) during pregnancy has prompted The European Medicine Agency (EMA)'s Pharmacovigilance and Risk Assessment Committee to recommend strengthening the restrictions for the use of valproate in women of childbearing age.

Specifically, the recommendations are that valproate not be used to treat epilepsy or bipolar disorder in girls and women who are pregnant or who can become pregnant unless other treatments are ineffective or not tolerated.

The Committee notes that women for whom valproate is the only treatment option should use effective contraception and that a doctor experienced in treating these conditions should start and supervise treatment.

The Committee also applies the recommendation to the use of valproate for the prevention of migraine.

The EMA recommendations result, in part, from a review of available data on the effects of valproate exposure during pregnancy which show that show preschool children exposed to valproate during pregnancy have up to a 30% to 40% risk for developmental problems, including delayed walking and talking, memory problems, difficulty with speech and language, and lower intellectual ability.

Further, children exposed to valproate in the womb are at an approximate 11% risk for birth defects such as neural tube defects and cleft palate, compared with a 2% to 3% risk among children in the general population. And, the data also suggest a 3-fold increased risk for a child having an autistic spectrum disorder and a 5-fold increased risk for childhood autism.

The Committee also noted that limited data indicate that children who suffer fetal exposure to valproate may be more likely to develop symptoms of attention-deficit/hyperactivity disorder.