Phenobarbital Pregnancy and Breastfeeding Warnings
Phenobarbital Pregnancy Warnings
Phenobarbital has been assigned to pregnancy category D by the FDA. An increased risk of congenital malformations has been associated with use of anticonvulsants agents (including phenobarbital) during pregnancy. Anomalies associated with anticonvulsant use in pregnancy include neural tube defects, cleft lips, cleft palates, cardiac defects, and microcephaly. Neonatal barbiturate withdrawal symptoms have also been reported in infants whose mothers took phenobarbital during pregnancy. There are no controlled data in human pregnancy. Phenobarbital should only be given during pregnancy when there are no alternatives and benefit outweighs risk.
Phenobarbital exposure in utero has been reported to potentially have long term deleterious effects on cognitive performance. A recent prospective case control cohort study of pregnant women with epilepsy has reported that phenobarbital, phenytoin, and carbamazepine are all associated with an increased risk of fetal death and anomalies. In addition, of these three antiepileptic medications, phenobarbital was associated with the poorest pregnancy outcome in terms of fetal death and anomalies. 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.
Phenobarbital Breastfeeding Warnings
Phenobarbital is excreted into human milk in small amounts. However, because of the prolonged half-life of the drug in neonates, accumulation of phenobarbital may occur and neonatal serum levels can potentially exceed maternal serum levels. Sedation and lethargy have been reported in nursing infants. The American Academy of Pediatrics classifies phenobarbital as a drug which has "caused significant effects in some nursing infants and should be given to nursing mothers with caution". Some investigators have recommended close monitoring of infant blood concentrations if a nursing mother must take phenobarbital.
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