Chlorpropamide Pregnancy and Breastfeeding Warnings

Chlorpropamide is also known as: Diabinese

Chlorpropamide Pregnancy Warnings

Chlorpropamide has been assigned to pregnancy category C by the FDA. Animal studies have not been reported. However, other sulfonylureas have been associated with an increased teratogenic risk in animal studies. There are no controlled data in human pregnancy. Congenital anomalies have been reported in association with chlorpropamide use during gestation although causality is unknown. In addition, the use of oral sulfonylureas during pregnancy has been reported to result in neonatal hypoglycemia. Insulin remains the mainstay of therapy for gestational diabetes due to the close glucose control it affords. Chlorpropamide is generally considered contraindicated during pregnancy and is only recommended for use during pregnancy when there are no alternatives and benefit outweighs risk. If chlorpropamide must be used, it should be discontinued at least one month before expected delivery to prevent neonatal side effects.

Diabetes mellitus is a known risk factor for abnormal pregnancy outcome. One review cites a four- to six-fold increase in congenital anomalies among infants born to women with insulin-dependent diabetes mellitus compared to control populations. Such an association makes evaluation of teratogenic risk of chlorpropamide or other pharmacologic therapy difficult. Jackson and Campbell (1963) retrospectively analyzed hospital records and found 25 pregnancies in which chlorpropamide was used to treat diabetes mellitus. Of these 25 pregnancies, there were 16 perinatal deaths. All of the deaths were associated with maternal chlorpropamide doses of 500 mg daily. The authors did not find any association between gestational chlorpropamide use and congenital anomalies although autopsy data were only available for a few cases. In a study evaluating 701 infants born to diabetic women over a 25-year period, congenital anomalies occurred in 5 infants whose mothers received oral sulfonylureas during pregnancy (N=60). Of 46 pregnancies in which oral sulfonylureas were used in the first trimester, four infants had congenital anomalies. The incidence of congenital defects in pregnancies treated with oral sulfonylureas (8.3%) was similar to the overall incidence for the study (8.1%), indicating that these agents are not associated with an increased teratogenic risk. Profound, prolonged neonatal hypoglycemia has been reported in infants delivered of women treated with chlorpropamide up to the time of delivery. Infant chlorpropamide serum concentrations were near the usual range for adult patients. Hyperinsulinemia was documented in several cases.

Chlorpropamide Breastfeeding Warnings

Chlorpropamide is excreted into human milk in small amounts. Adverse effects in the nursing infant are unknown. The manufacturer recommends that due to the potential adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

The manufacturer reports an average chlorpropamide concentration in breast milk of 5 mcg/mL five hours after oral administration of chlorpropamide 500 mg in one patient. Normal chlorpropamide peak plasma concentrations average 30 mcg/mL following a single 250 mg oral dose.

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