Valpros Pedia Use In Pregnancy & Lactation

Use in Pregnancy: Pregnancy Category D. Valproate can produce teratogenic effects. Sodium valproate should not be used in women of childbearing potential unless clearly necessary (i.e., other treatments are ineffective or not tolerated). This is especially important when valproate use is considered fora condition not usually associated with permanent injury or death (e.g., migraine). Women should use effective contraception while using valproate.
Antiepileptic drugs should not be discontinued abruptly in patients in whom the drug is used to prevent major seizures because of the strong possibility of precipitating status epilepticus with attendant hypoxia and threat to life. Even minor seizures may pose some hazard to the developing embryo or fetus. However, discontinuation of the drug may be considered prior to and during pregnancy in individual eases if the seizure severity and frequency do not pose a serious threat to the patient.
If appropriate, folic acid supplementation should be given both prior to and during pregnancy at relevant doses (5 mg/day) as it may minimize the risk of neural tube defects.
Congenital Malformations: The strongest association of maternal valproate usage with congenital malformations is with neural tube defects. However, other congenital anomalies (e.g., craniofatal defects, cardiovascular malformations and anomalies involving various body systems), compatible and incompatible with life, have been reported. Sufficient data to determine the incidence of these congenital anomalies is not available.
Neural Tube Defects: The incidence of neural tube defects in the fetus is increased in mothers receiving valproate during the first trimester of pregnancy. Tests to detect neural tube and other defects using current accepted procedures should be considered a part of routine prenatal care in pregnant women receiving valproate.
Cerebral Atrophy and Decreased IQ Following in utero Exposure: Reports of cerebral atrophy with various forms of neurological problems including developmental delays and psychomotor impairment have also been reported in children who were exposed in utero to valproate products.
Clinical evidence suggests that valproate exposure in utero can cause decreased IQ in children. Because women in the study were exposed to antiepileptic drugs throughout pregnancy, whether the risk for decreased IQ was related to a particular time period during pregnancy could not be assessed.
Risk in the Neonate: Very rare cases of hemorrhagic syndrome have been reported in neonates whose mothers have taken sodium valproate during pregnancy. This hemorrhagic syndrome is related to hypofibrinogenemia. Afibrinogenemia has also been reported and may be fatal. These are possibly associated with a decrease of coagulation factors. However, this syndrome has to be distinguished from the decrease of the vitamin-K factors induced by phenobarbital and other anti-epileptic enzyme inducing drugs. Therefore, platelet count, fibrinogen plasma level, coagulation tests and coagulation factors should be investigated in neonates.
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.
Serious reports of hypoglycemia and hypothyroidism have been reported in neonates whose mothers have taken valproate during pregnancy. Most neonates also displayed other congenital anomalies including hypospadias, complex facial dysmorphism, limb anomalies, severe cardiac anomalies, etc.
Use in Lactation: Valproate is excreted in breast milk. Concentrations in breast milk have been reported to be 1 to 10% of serum concentration. Consideration should be given to discontinuing breastfeeding when sodium valproate is administered to a breastfeeding woman.