Valtor Use In Pregnancy & Lactation

Pregnancy (see Contraindications and Women of childbearing potential and Use in Pregnancy under Precautions): Risks associated with valproic acid: In humans: Valproic acid may produce teratogenic effects, such as neural tube defects (e.g. spina bifida) in the offspring of human females receiving the drug during pregnancy. There are data that suggest an increased incidence of congenital malformations associated with the use of valproic acid during pregnancy. Therefore, valproic acid should be considered for women of childbearing potential only after the risks have been thoroughly discussed with the patient and weighed against the potential benefits of treatment.
There are multiple reports in the clinical literature that indicate the use of antiepileptic drugs during pregnancy results in an increased incidence of birth defects in the offspring. Therefore, antiepileptic drugs should be administered to women of childbearing potential only if they are clearly shown to be essential in the management of their disease.
The incidence of neural tube defects in the fetus may be increased in mothers receiving valproate during the first trimester of pregnancy. The United States Centers for Disease Control (CDC) has estimated the risk of valproic acid exposed women having children with spina bifida to be approximately 1-2%. Other congenital anomalies (e.g., craniofacial defects, cardiovascular malformations, hypospadias, and anomalies involving various body systems), compatible and incompatible with life, have been reported.
There was an increased incidence of congenital malformations in children born to epileptic women exposed to valproate monotherapy during pregnancy. Available data indicate dose-dependency of this effect.
Valproate can cause decreased IQ scores following in utero exposure. Published epidemiological studies have indicated that children exposed to valproate in utero have lower cognitive test scores than children exposed in utero to either another antiepileptic drug or to no antiepileptic drugs.
There have been reports of developmental delay, autism, and/or autism spectrum disorder in the offspring of women exposed to valproic acid during pregnancy.
Exposure in utero to valproate products has been associated with cerebral atrophy with varying degrees/manifestations of neurological compromise, including developmental delays and psychomotor impairment (see Adverse Reactions and Precautions).
In animals: Animal studies have demonstrated valproate-induced teratogenicity. Increased frequencies of malformations, as well as intrauterine growth retardation and death, have been observed in mice, rats, rabbits, and monkeys following prenatal exposure to valproate. Malformations of the skeletal system are the most common structural abnormalities produced in experimental animals, but neural tube closure defects have been seen in mice exposed to maternal plasma valproate concentrations exceeding 230 mcg/mL (2.3 times the upper limit of the human therapeutic range) during susceptible periods of embryonic development.
Risks in the neonates: Pregnant women taking valproate may develop clotting abnormalities, including thrombocytopenia, hypofibrinogenemia, and/or decrease in other coagulation factors, which may result in hemorrhagic complications in the neonate including death (see Thrombocytopenia and General under Precautions).
If valproate is used in pregnancy, the clotting parameters should be monitored carefully.
Hepatic failure, resulting in the death of a newborn and of an infant, has been reported following the use of valproate during pregnancy.
Cases of hypoglycemia have been received for neonates whose mothers have taken valproate during pregnancy.
Tests to detect neural tube and other defects using current accepted procedures should be considered a part of routine prenatal care in childbearing women receiving valproate.
Antiepileptic drugs should not be discontinued abruptly in patients in whom the drug is administered to prevent major seizures because of the strong possibility of precipitating status epilepticus with attendant hypoxia and threat to life. In individual cases, where the severity and frequency of the seizure disorder are such that the removal of medication does not pose a serious threat to the patient, discontinuation of the drug may be considered prior to and during pregnancy, although it cannot be said with any confidence that even minor seizures do not pose some hazard to the developing embryo or fetus.
Breastfeeding: Valproate is excreted in breast milk. Concentrations in breast milk have been reported to be 1-10% of serum concentrations. It is not known what effect this would have on a nursing infant. Consideration should be given to discontinuing nursing when valproic acid is administered to a nursing woman (see Use in Pregnancy under Precautions).