Pregnancy: Phenobarbitone therapy in epileptic pregnant women presents a risk to the foetus in terms of major and minor congenital defects such as congenital craniofacial, digital abnormalities and, less commonly, cleft lip and palate. The risk of teratogenic effects developing appears to be greater if more than one antiepileptic drug is administered. The risk to the mother, however, is greater if phenobarbitone is withheld and seizure control is lost. The risk-benefit balance, in this case, favours continued use of the drug during pregnancy at the lowest possible level to control seizures.
Patients taking phenobarbitone should be adequately supplemented with folic acid before conception and during pregnancy. Folic acid supplementation during pregnancy can help to reduce the risk of neural defects to the infant.
Phenobarbitone readily crosses the placenta following oral administration and is distributed throughout foetal tissue, the highest concentrations being found in the placenta, foetal liver and brain. Adverse effects on neurobehavioral development have also been reported.
Haemorrhage at birth and addiction are also a risk. Prophylactic treatment with vitamin K1 for the mother before delivery (as well as the neonate) is recommended, the neonate should be monitored for signs of bleeding.
Lactation: Phenobarbitone is excreted into breast milk and there is a small risk of neonatal sedation. Phenobarbitone is eliminated slowly in neonates and may accumulate. Therefore, the benefits of breastfeeding should be weighed against the possible risks to the infant and a decision should be made whether to discontinue nursing or to discontinue phenobarbitone, taking into account the importance of the drug to the mother. Breastfed infants should be observed for excessive drowsiness, dizziness, feeding problems, allergic skin reactions such as rash or other adverse reactions. If any of these occur, breastfeeding should be discontinued. When breastfeeding is discontinued, there is a potential for withdrawal symptoms in infants.