Carbamazepine Pregnancy and Breastfeeding Warnings

Carbamazepine is also known as: Carbatrol, Epitol, Equetro, Tegretol, Tegretol XR

Carbamazepine Pregnancy Warnings

A prospective controlled study of 210 women treated with carbamazepine at least during the first trimester has suggested a twofold increase in the rate of major congenital anomalies. The results were 12/160 in the carbamazepine group versus 18/560 in the general control. There was also a birth weight reduction of approximately 250 g after in utero exposure to carbamazepine. A prospective case control cohort study of pregnant women with epilepsy has reported an association between carbamazepine therapy and fetal death and anomalies. In that study, carbamazepine was associated with the lowest risk of three major antiepileptic drugs (phenytoin, phenobarbital, and carbamazepine). The relative risk of abnormal outcome was 0.019 in carbamazepine-treated women. In one study of 100 pregnancies in which the mothers were taking carbamazepine, 7 malformed offspring were reported. No significant differences in carbamazepine and metabolite levels were observed between those pregnancies which ended in malformation and those pregnancies which ended in normal offspring. Many of the epileptic women in this study were taking other antiseizure medications. Another study has suggested that carbamazepine exerts no negative effects on neurodevelopment in children exposed to carbamazepine in utero. In one case of massive overdose of carbamazepine during the third or fourth week post-conception, the fetus developed a large neural tube defect. A case of transient cholestatic hepatitis has been reported in an infant between the third and seventh weeks of life. The author of the report stated that it was "most likely due to carbamazepine exposure during pregnancy and breast feeding." To provide information regarding the effects of in utero exposure to carbamazepine, physicians are advised to recommend that pregnant patients taking carbamazepine enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. This can be done by calling the toll free number 1-888-233-2334, and must be done by patients themselves. Information on the registry can also be found at the website http://www.aedpregnancyregistry.org/.

Carbamazepine has been assigned to pregnancy category D by the FDA. Carbamazepine can cause fetal harm when administered to a pregnant woman. Epidemiological data suggest that there may be an association between the use of carbamazepine during pregnancy and congenital malformations, including spina bifida. The prescribing physician should weigh the benefits of therapy against the risks in treating or counseling women of childbearing potential. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. Tests to detect defects using current accepted procedures should be considered a part of routine prenatal care in childbearing women receiving carbamazepine. Patients should be encouraged to enroll in the NAAED Pregnancy Registry if they become pregnant. This registry is collecting information about the safety of antiepileptic drugs during pregnancy. To enroll, patients can call the toll free number 1-888233-2334.

Carbamazepine Breastfeeding Warnings

Carbamazepine and its epoxide metabolite are transferred to breast milk during lactation. Because of the potential for serious adverse reactions in nursing infants from carbamazepine, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

A case of transient cholestatic hepatitis has been reported in an infant between the third and seventh weeks of life. The author of the report stated that it was "most likely due to carbamazepine exposure during pregnancy and breast feeding."

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