Research and analysis

Public Assessment Report: safety of macrolide antibiotics in pregnancy: a review of the epidemiological evidence

The Commission on Human Medicines (CHM) has reviewed the available safety data for the use of the macrolide antibiotics erythromycin, clarithromycin and azithromycin during pregnancy.

Documents

Safety of macrolide antibiotics in pregnancy: a review of the epidemiological evidence

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Annex 1: Table 1

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Annex 2: Tables 1

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Annex 2: Table 2

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Annex 2: Table 3

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Annex 2: Table 4

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Annex 3: Table 1

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Annex 3: Table 2

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Annex 3: Table 3

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Details

This report presents our review of the safety of macrolide antibiotics erythromycin, clarithromycin and azithromycin during early pregnancy. The review evaluated the quality of the safety evidence in relation to three outcomes: major malformations of the baby in the womb, heart or blood vessel malformations, and miscarriage.

Certain infections in pregnancy can cause serious harm to both to the mother and baby if not treated. In such cases, pregnant women should receive treatment with an appropriate antibiotic. Decisions by the prescriber of which antibiotic to use should be based on the benefits and risk to mother and baby. If a prescriber views that the potential benefits of treatment will outweigh the risks and that no suitable and safe alternative is available, for example in true penicillin allergy, a macrolide can be used during pregnancy.

Published 28 June 2021