Carbamazepine Pregnancy and Breast Feeding Warnings
Carbamazepine is also known as: Carbatrol, Epitol, Equetro, Tegretol, Tegretol XR
Overview
Carbamazepine Chewable Tablets has been shown to cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Carbamazepine Chewable Tablets while pregnant. Carbamazepine Chewable Tablets is found in breast milk. Do not breast-feed while taking Carbamazepine Chewable Tablets.
Carbamazepine Pregnancy Warnings
Carbamazepine has been assigned to pregnancy category C by the FDA. Anomalies similar to the fetal hydantoin syndrome have been described and include minor craniofacial defects, fingernail hypoplasia, and developmental delay. Other investigators have reported a variety of defects including spina bifida and a decrease in intelligence. Carbamazepine may be a teratogen, although studies of its effects during pregnancy are inconclusive. Carbamazepine should only be given during pregnancy if benefit outweighs risk.
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." 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.
Carbamazepine Lactation Warnings
Carbamazepine is excreted into human milk in small amounts. Serum concentrations in infants are often low but occasionally approach the therapeutic range. Dose-related effects have not been reported. Carbamazepine is considered compatible with breast-feeding by the American Academy of Pediatrics.
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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