FDA is reminding healthcare professionals and patients about an increased risk of birth defects in infants whose mothers took valproate sodium and related products during pregnancy. These drugs, which are used to treat epilepsy, bipolar disorder and migraine headaches, include valproate sodium, valproic acid and divalproex sodium. They are marketed as Depacon (valproate sodium injection), Depakene (valproic acid), Stavzor (valproic acid), and Depakote (divalproex sodium).
Valproate has been associated with neural tube defects and craniofacial defects, as well as cardiovascular and other malformations. These kinds of malformations occur almost four times more frequently in babies born to women with epilepsy who took valproate during pregnancy than in babies born to women with epilepsy who used other anti-epileptic drugs.
Physicians should consider alternative therapies for women of childbearing age, especially if valproate is used for migraines and other conditions not usually considered life threatening. They should inform women who are taking or considering valproate about the risk of birth defects, and they should recommend contraception for those who are not planning a pregnancy.
Physicians should also advise patients that taking folic acid before and during the first trimester can decrease the risk of neural tube defects. FDA will require that a Medication Guide explaining the benefits and risks of valproate be provided with each outpatient prescription.
Women who become pregnant while taking valproate should be offered prenatal testing to detect malformations, and they should be encouraged to enroll in a special registry that gathers information about the effects of antiepileptic drugs during pregnancy.