Divalproex sodium Pregnancy and Breast Feeding Warnings
Divalproex sodium is also known as: Depakote, Depakote ER, Depakote Sprinkles
Overview
Divalproex Extended-Release Tablets has been shown to cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Divalproex Extended-Release Tablets while you are pregnant. Divalproex Extended-Release Tablets is found in breast milk. Do not breast-feed while you are taking Divalproex Extended-Release Tablets.
Divalproex sodium Pregnancy Warnings
Divalproex sodium has been assigned to pregnancy category D by the FDA. Evidence strongly suggests that valproate is a human teratogen and causes neural tube closure defects in 1% to 2% of infants exposed in utero. A fetal valproate syndrome which includes defects of the face, heart, and limbs has also been described. A four-fold increase in congenital malformations has been reported among infants with valproic acid-exposed mothers compared with those treated with other antiepileptic monotherapies (as a group). A patient who had low fibrinogen when taking multiple anticonvulsants including valproate gave birth to an infant with afibrinogenemia who subsequently died of hemorrhage. Patients taking valproate may develop hepatic failure. Fatal hepatic failures, in a newborn and in an infant, have been reported following the maternal use of valproate during pregnancy. Divalproex sodium therapy should be administered to women of childbearing potential only if clearly shown to be essential in the management of their medical condition. If a decision to continue pregnancy is made, the patient should be offered prenatal testing for neural tube defects. If valproic acid is used during pregnancy, the clotting parameters should be monitored carefully.
Valproate can produce teratogenic effects such as neural tube defects (e.g. spina bifida). The use of valproate products in women of childbearing potential requires that the use of its benefits be weighed against the risk of injury to the fetus. This is especially important when the treatment of a spontaneously reversible condition not ordinarily associated with permanent injury or risk of death (e.g., migraine) is contemplated. One study has reported that both valproic acid and its principal metabolites are found in amniotic fluid. In that study of 52 pregnancies in epileptic women taking valproic acid, 5 fetal neural tube defects were reported. Maternal serum levels of valproate were significantly higher in pregnancies which resulted in a neural tube defect than in pregnancies which resulted in normal infants. An in vitro study of the teratogenic effects of valproic acid has suggested that valproic acid may disrupt chondrogenesis by reducing mitosis and altering matrix production. Two workers have suggested that periconceptional vitamin supplementation, particularly with vitamins containing calcium pantothenate, may reduce the risk of neural tube closure defects in women receiving valproic acid therapy. One recent patient series has suggested that benzodiazepines may amplify the teratogenic effects of valproic acid. Two cases of omphalocele along with the typical dysmorphic features of the fetal valproate syndrome have been reported in newborns whose mothers were receiving valproic acid therapy. A recent case report has suggested that valproic acid may cause hydranencephaly. Physicians are encouraged to register patients before fetal outcome is known (e.g., ultrasound, results of amniocentesis, etc) into the Antiepileptic Drug (AED) Pregnancy Registry at 1-888-233-2334 or 1-888-AED-AED4. This is an ongoing study at the Massachusetts General Hospital/Harvard Medical School. This study is designed to monitor the outcomes of pregnant women exposed to antiepileptic drugs in order to determine which therapies are associated with increased risk.
Divalproex sodium Lactation Warnings
Valproic acid is excreted into human milk at a level of approximately 1% to 10% of the level found in the mother's serum. Valproic acid is considered compatible with breast-feeding by the American Academy of Pediatrics. However, because of the potential threat of fatal liver toxicity in children under two years of age, some authors have recommended against nursing while the mother is on valproic acid.
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