Can I take carbamazepine while pregnant or breastfeeding?

8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), such as EQUETRO, during pregnancy. Healthcare providers are encouraged to recommend that pregnant patients taking EQUETRO enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry by calling 1-888-233-2334 or online at http://www.aedpregnancyregistry.org/ . Risk Summary EQUETRO can cause fetal harm when administered to a pregnantfemale [see Warnings and Precautions ( 5.5 )] . Pregnancy registry and epidemiological data suggest a potential association between the use of carbamazepine during pregnancy and major congenital malformations, including neural tube defects and malformations involving other body systems (e.g., craniofacial defects and cardiovascular malformations). The available data are insufficient to identify an association with carbamazepine use and miscarriage (see Data). There are risks to the mother and fetus associated with untreated bipolar I disorder or epilepsy and with exposure to carbamazepine during pregnancy (see Clinical Considerations).

Prescribing label, section “8.1 Pregnancy” (opening excerpt): EQUETRO (oral), Validus Pharmaceuticals LLC. Read the full section on DailyMed. Quoted verbatim; US labels are written for US prescribers and patients.

Breastfeeding during carbamazepine monotherapy does not appear to adversely affect infant growth or development, and breastfed infants had higher IQs and enhanced verbal abilities than nonbreastfed infants at 6 years of age in one study.[1] A safety scoring system finds carbamazepine possible to use during breastfeeding.[2] If carbamazepine is required by the mother, it is not a reason to discontinue breastfeeding.

Carbamazepine and its active metabolite have relatively high levels in breastmilk and breastfed infants have serum levels that are sometimes measurable, but usually well below the anticonvulsant therapeutic range. Most infants have had no adverse reactions, but sedation, poor sucking, withdrawal reactions and 3 cases of hepatic dysfunction have been reported. These have all been complicated because of intrauterine exposure and, in some cases, concurrent drug therapy. Monitor the 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. One author recommends monitoring infant serum carbamazepine levels, liver enzymes, and a complete blood count during therapy.[3]

“Summary of Use during Lactation”, LactMed record “Carbamazepine” (LM400), quoted verbatim. Everything LactMed reports about Carbamazepine while breastfeeding.

8.2 Lactation Carbamazepine and its epoxide metabolite are present in human milk. Most infants with reported exposure to carbamazepine through human milk have not had adverse reactions; however, there are a few reported cases of hepatitis, regurgitations, poor weight gain, and vomiting in breastfed infants of females taking carbamazepine. There are no data on the effects of carbamazepine on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for EQUETRO and any potential adverse effects on the breastfed child from EQUETRO or from the underlying maternal condition.

Prescribing label, section “8.2 Lactation”: EQUETRO (oral), Validus Pharmaceuticals LLC. Label on DailyMed. Quoted verbatim; US labels are written for US prescribers and patients.