Digoxin Pregnancy and Breastfeeding Warnings
Digoxin Pregnancy Warnings
There are no reports of congenital defects associated with digoxin. Digoxin crosses the placenta with increasing fetal accumulation throughout gestation. Umbilical cord concentrations reported have been 50%, 81%, and 83% of maternal serum levels. The fetal heart has a limited ability to bind digoxin during the first half of human gestation, but concentrates digoxin in the second half. Fetal and neonatal tolerance is greater (2 to 4 ng/mL) than that of adults (less than 2 ng/mL). Monitoring of serum digoxin levels, both antepartum and postpartum, is recommended as maternal plasma clearance of digoxin is significantly increased during pregnancy.
Digoxin has been assigned to FDA pregnancy category C by the FDA. Animal studies failed to reveal evidence of teratogenicity. There are no controlled data in human pregnancy. Digoxin has been used successfully to treat maternal congestive heart failure and arrhythmias and fetal arrhythmias throughout gestation without reports of fetal harm, however, digoxin should be given during pregnancy only when benefit outweighs risk.
Digoxin Breastfeeding Warnings
Digoxin is excreted into human milk, however, nursing infant exposure is limited. Pharmacologic and/or adverse effects are not anticipated. However, the manufacturer recommends caution when administering digoxin to nursing women.
Digoxin milk to maternal serum concentration ratios of 0.6 to 0.9 have been reported. Data from two women taking digoxin 0.25 mg daily revealed mean peak digoxin milk levels of 0.61 to 0.96 ng/mL at 4 and 6 hours after dosing, respectively. The mean digoxin milk levels in these two patients were 0.78 and 0.41 ng/mL, respectively. Digoxin could not be detected in the plasma of either nursing infant (radioimmunoassay sensitivity of 0.1 ng/mL). The authors calculated that should the nursing infants consume 150 mL of milk/kg/day, the digoxin burden would be 0.12 and 0.06 mcg/kg/day, respectively. These amounts are associated with subtherapeutic neonatal levels. A case in which a mean milk digoxin level of 1.9 ng/mL was similar to the maternal plasm level has been reported. The mother was taking digoxin 0.75 mg daily. This milk digoxin level is considerably higher than other levels reported, however, the digoxin burden to the nursing infant was reported as 0.2 ng/mL.
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