Clarithromycin Pregnancy and Breastfeeding Warnings

Clarithromycin is also known as: Biaxin, Biaxin XL

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

There are no data on the excretion of clarithromycin into human milk. Clarithromycin is excreted in the milk of lactating animals, and other drugs in the macrolide class are known to be excreted in human milk. The manufacturer recommends that caution be used when administering clarithromycin to nursing women.

See Also...

• 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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