Clonidine Pregnancy and Breastfeeding Warnings
Clonidine Pregnancy Warnings
Clonidine crosses the placenta. Limited data from 10 pregnant women have shown that the average umbilical cord to maternal clonidine concentration ratio averages 0.9. No adverse fetal effects in human pregnancy have been observed, but data are limited. Data from the Michigan Medicaid Birth Defects Study (MMBDS) has revealed an unexpectedly high incidence of birth defects associated with the use of clonidine (written communication, Franz Rosa, MD, Food and Drug Administration, 1994). The MMBDS is a retrospective study of 229,101 pregnancies from 1985 to 1992, of which 59 were exposed to clonidine during the first trimester of pregnancy. Of the 59 pregnancies that were exposed to clonidine, there were 3 total and 2 cardiovascular defects observed (2.0 and 0.5 were expected, respectively). Cleft palate, spina bifida, polydactyly, limb reduction/syndactyly, or hypospadia were not observed. Because of the low numbers of exposures, no definite conclusions regarding an association or lack of association between clonidine and birth defects may be made.
Clonidine has been assigned to pregnancy category C by the FDA. Animal studies have failed to reveal evidence of teratogenicity although an increased incidence of fetal resorption has been demonstrated in some species. While there are no controlled data from human pregnancy studies, clonidine has been used safely during all three trimesters of human pregnancy (1st trimester exposure has been limited). Clonidine should only be given during pregnancy when benefit outweighs risk.
Clonidine Breastfeeding Warnings
Limited data have shown that the average concentration of clonidine in human milk is approximately twice that observed in the maternal plasma. In one case, in which the mother was taking clonidine 37.5 mcg twice a day, the milk and maternal plasma clonidine levels were 0.60 and 0.33 ng per mL, respectively, while the plasma level in the infant was undetectable. No adverse effects were observed in the nursing infant. The authors calculated that, if the nursing infant consumed 150 mL per kg, it would have ingested clonidine 90 ng per kg per day, compared to the maternal drug dosage of 1,320 ng per kg per day (maternal weight 57 kg). Therefore, the relative clonidine dosage of the infant would have been 6.8% of the mothers. Two other reports of the use of clonidine during breast-feeding have shown that the plasma clonidine levels of the infants averaged 60% to 80% of the maternal plasma levels. Prenatal exposure to clonidine has been associated with transitory hypertension during the first three days of life and with hyperactivity and sleep disturbances in six-year-old children. While hypotension has not been observed in nursing infants whose mothers were taking up to 0.4 mg of clonidine per day, data from long-term exposure to nursing infants are unavailable.
Clonidine is secreted into human milk. Limited data have failed to reveal evidence of adverse effects among nursing infants even though milk concentrations have shown to be double the concentration of clonidine compared with maternal serum concentrations. The manufacturer recommends that caution be used when administering clonidine to nursing women.
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