Divalproex sodium Pregnancy and Breastfeeding Warnings
Divalproex sodium Pregnancy Warnings
-This drug can cause fetal harm when administered to a pregnant woman. Pregnancy registry data show maternal valproate use can cause neural tube defects and other structural abnormalities (e.g., craniofacial defects, cardiovascular malformations, hypospadias, limb malformations). The rate of congenital malformations among babies born to mothers using valproate is about 4 times higher than the rate among babies born to epileptic mothers using other anti-seizure monotherapies. Evidence suggests that folic acid supplementation prior to conception and during the first trimester of pregnancy decreases the risk for congenital neural tube defects in the general population. -Children born to mothers who take this drug during pregnancy have an increased risk of lower cognitive test scores than children exposed to other antiseizure medications during pregnancy. -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 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. To provide information regarding the effects of in utero exposure to valproic acid, physicians are advised to recommend that pregnant patients taking valproate 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: 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.
Migraine Prophylaxis: Use is contraindicated (US) Epilepsy: This drug should be used during pregnancy only if clearly needed and the benefit outweighs the risk US FDA pregnancy category: X (prophylaxis of migraine headaches) US FDA pregnancy category: D (epilepsy and for manic episodes associated with bipolar disorder) Comments: -Use of this drug is not recommended during pregnancy. If this drug is used during pregnancy, or if the patient becomes pregnant while receiving this drug, the patient should be apprised of the potential hazard to the fetus.
Divalproex sodium Breastfeeding Warnings
Because of the low levels of valproic acid in breastmilk and infant serum, no adverse reactions to valproic acid during breastfeeding have been reported. Theoretically, breastfed infants are at risk for valproic acid-induced hepatotoxicity, so infants should be monitored for jaundice and other signs of liver damage during maternal therapy.
UK: A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. US: Caution should be exercised when valproate is administered to a nursing woman. Excreted into human milk: Yes (at a concentration ranging from 1% to 10% of maternal serum levels)
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