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Clarithromycin Pregnancy and Breastfeeding Warnings

Clarithromycin is also known as: Biaxin, Biaxin XL

Clarithromycin Pregnancy Warnings

FDA pregnancy category: C Use of clarithromycin is not recommended except in clinical circumstances where no alternative therapy is appropriate and the benefit outweighs the risk to the fetus. Comments: If pregnancy occurs during clarithromycin therapy, the patient should be apprised of the potential hazard to the fetus.

Animal studies have revealed adverse effects of pregnancy outcome and/or embryofetal 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. There are limited controlled data in human pregnancy. A prospective, controlled, multicenter study of 157 pregnant women found clarithromycin to be safe when taken at the usual prescribed dosage during pregnancy. 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%); the authors suggest that the difference could be due to confounding factors not controlled by their study. FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

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

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