Clarithromycin Pregnancy and Breastfeeding Warnings
Clarithromycin Pregnancy Warnings
Clarithromycin has been assigned to pregnancy category C by the FDA. Animal studies have revealed adverse effects of pregnancy outcome and/or embryo-fetal development (a low incidence of cardiovascular anomalies and cleft palate) at doses that produced plasma levels 2 to 17 times the serum levels achieved in humans treated at the maximum recommended human doses. A prospective, controlled, multicenter study of 157 pregnant women found clarithromycin to be safe when taken at the usual prescribed dosage during pregnancy. The manufacturer recommends that clarithromycin not be used in pregnant women except in clinical circumstances where no alternative therapy is appropriate and the benefit justifies the potential risk to the fetus. If pregnancy occurs during therapy with clarithromycin, the patient should be apprised of the potential hazard to the fetus.
In the study, 122 of the women had first-trimester exposure to clarithromycin. The incidence of major and minor congenital malformations did not differ from the background incidence of 1% to 3% and 10% to 15%, respectively, in first-trimester exposure to clarithromycin. The rate of spontaneous abortion in the clarithromycin group was statistically higher than in the control group (14% versus 7%), although the authors suggest that the difference could be due to confounding factors not controlled by their study.
Clarithromycin Breastfeeding Warnings
Clarithromycin and its active metabolite (14-hydroxy-clarithromycin) are excreted into human milk. In 1 study, steady-state serum and milk samples were collected from 12 lactating women after 3 days of therapy (250 mg orally twice a day). Based on limited data from this study (and assuming milk consumption of 150 mL/kg/day), a child exclusively fed human milk would receive 136 mcg/kg/day (estimated average) of clarithromycin and its active metabolite with this maternal regimen. This is less than 2% of the maternal weight-adjusted dose and less than 1% of the pediatric dose (15 mg/kg/day) for children over 6 months. A prospective observational study compared 55 infants breastfed by mothers taking macrolide antibiotics (6 clarithromycin) to 36 infants breastfed by mothers taking amoxicillin. Side effects were reported in 12.7% of infants exposed to macrolides (similar to rate in amoxicillin-exposed infants) and included rash, diarrhea, loss of appetite, and somnolence.
Caution is recommended. Excreted into human milk: Yes Excreted into animal milk: Yes The following should be considered: -The development and health benefits of human milk feeding -The mother's clinical need for clarithromycin -Potential side effects in the human milk fed child due to the drug or the mother's underlying condition
- Clarithromycin use while Breastfeeding (in more detail)
- Clarithromycin Consumer Information
- Pregnancy Support Group
- FDA Pregnancy Categories
- Medicine use during Pregnancy
- Medicine use while Breastfeeding
- Safe Medications during Breastfeeding
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