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Carbamazepine Pregnancy and Breastfeeding Warnings

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

Carbamazepine Pregnancy Warnings

-Data suggest that there may be an association between the use of this drug during pregnancy and congenital malformations, including spina bifida. This drug has also been associated with developmental disorders and congenital anomalies (e.g., craniofacial defects, cardiovascular malformations, hypospadias, and anomalies involving various body systems). Developmental delays based on neurobehavioral assessments have been reported. -Compared with monotherapy, there may be a higher prevalence of teratogenic effects associated with the use of anticonvulsants in combination therapy. Therefore, if therapy is to be continued, monotherapy may be preferable for pregnant women. -In humans, transplacental passage of this drug is rapid (30 to 60 minutes), and the drug is accumulated in the fetal tissues, with higher levels found in liver and kidney than in brain and lung. 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/. 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.

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. AU TGA pregnancy category: D US FDA pregnancy category: D Comments: -This drug can cause fetal harm when administered to a pregnant woman.

Carbamazepine Breastfeeding Warnings

AU, UK: This drug should be used only if clearly needed. US: A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Yes Comments: -Carbamazepine is excreted into human milk (about 25% to 60% of plasma levels). -Serum concentrations in infants are often low but occasionally approach the therapeutic range.

-Most infants have had no adverse reactions, but sedation, poor sucking, withdrawal reactions and 3 cases of hepatic dysfunction have been reported. --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. -The infant should be monitored 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.

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