This drug may cause fetal harm when administered to pregnant women. Epidemiological data suggests an association between the use of this drug during pregnancy and congenital malformations, including spina bifida. Developmental disorders, developmental delays based on neurobehavioral assessments, and congenital anomalies (e.g., craniofacial defects, cardiovascular malformations, and anomalies involving various body systems) have also been reported.
-Retrospective case reviews suggest a higher prevalence of teratogenic effects with combination anticonvulsants use compared to monotherapy, therefore, if possible, monotherapy is preferable for pregnant women.
-This drug crosses the placenta with higher levels found in liver and kidney than in brain and lung.
-Folic acid deficiency is known to occur during pregnancy and antiepileptic drugs are known to aggravate this condition. Folic acid supplementation should begin 4 weeks prior to and continue for at least twelve weeks after conception.
-In order to prevent bleeding disorders in neonate, Vitamin K should be given to the mother during the last weeks of pregnancy, and to the neonate as well.
-There have been a few cases of neonatal seizures and/or respiratory depression associated with maternal use of this drug and other concomitant anticonvulsants. Cases of neonatal vomiting, diarrhea, and/or decreased feeding have also been reported with maternal carbamazepine use and may represent a neonatal withdrawal syndrome.
-Antiepileptic drugs should not be abruptly discontinued because of the possibility of precipitating seizures.

AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

US 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.

This drug should be used during pregnancy only if clearly needed; if patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.

AU TGA pregnancy category: D
US FDA pregnancy category: D

Comments:
-This drug can cause fetal harm when administered to a pregnant woman; the risks with polytherapy are greater than the risk associated with monotherapy; the risk of a mother with epilepsy giving birth to a baby with an abnormality is about three times higher that of the general population.
-Tests to detect defects using currently accepted procedures should be considered a part of routine prenatal care in childbearing women receiving this drug.
-To monitor the outcomes of pregnant women exposed to this drug, a pregnancy registry has been established. Physicians are encouraged to register patients and pregnant women are encouraged to register themselves by calling 1-888-233-2334. Information on the registry can also be found at the website http://www.aedpregnancyregistry.org/

See references

Benefit should outweigh risk

Excreted into human milk: Yes

Comments:
-Carbamazepine is excreted into human milk (about 25% to 60% of plasma levels).
-Monitor for jaundice, drowsiness, adequate weight gain, and developmental milestones.

This drug and its epoxide metabolite are present in breast milk at drug ratio concentrations (breast milk: maternal plasma) of 0.4 and 0.5, respectively. Because of the potential for serious reactions in breastfed infants, the benefits of breastfeeding must be carefully weighed against possible adverse effects. Many infants have had no adverse reactions, but sedation, poor sucking, withdrawal reactions, and 3 cases of hepatic dysfunction have been reported. In some of these cases, concurrent therapy may have contributed to adverse reactions. Breastfeeding during monotherapy does not appear to adversely affect infant growth or development. In a breastfeeding study among women on monotherapy for epilepsy (i.e. carbamazepine, lamotrigine, phenytoin, or valproate) breastfed infants had higher IQs and enhanced verbal abilities compared to non-breastfed infants at 6 years of age.

If breastfeeding, monitor infant for jaundice, drowsiness, adequate weight gain, and developmental milestones, especially in younger, exclusively breastfed infants, and when using combinations of anticonvulsant or psychotropic drugs. Some clinicians recommend monitoring infant serum carbamazepine levels, liver enzymes, and a complete blood count during therapy.

See references