Valproic acid Pregnancy and Breastfeeding Warnings
Valproic acid Pregnancy Warnings
Valproate can produce teratogenic affects 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 valproate has suggested that valproate may disrupt chondrogenesis by reducing mitosis and altering matrix production. It has been 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 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. A case report has suggested that valproic acid may cause hydranencephaly. A case of aplasia cutis congenita of the scalp has been reported in an infant exposed to valproic acid in utero. FDA pregnancy category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. FDA pregnancy category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits. To provide information regarding the affects of in utero exposure to valproic acid, physicians are advised to recommend that pregnant patients taking valproic acid enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. This can be done by calling the toll free number 1-888-233-2334, and must be done by patients themselves. Information on the registry can also be found at the website http://www.aedpregnancyregistry.org/.
FDA pregnancy category D for treating epilepsy and manic episodes associated with bipolar disorder. FDA pregnancy category X for treating migraine headaches. Evidence strongly suggests that valproate is a human teratogen and causes neural tube closure defects in 1% to 2% of infants exposed in utero. There is also an increased risk of other major birth defects such as craniofacial defects and cardiovascular malformations. 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. FDA notified healthcare professionals that children born to mothers who take the valproic acid or related products (valproate sodium and divalproex sodium) during pregnancy have an increased risk of lower cognitive test scores than children exposed to other antiseizure medications during pregnancy. Valproate 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.
Valproic acid Breastfeeding 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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