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Associations between macrolide antibiotics prescribing during pregnancy and adverse child outcomes in the UK: population based cohort study

BMJ 2020; 368 doi: https://doi.org/10.1136/bmj.m766 (Published 04 March 2020) Cite this as: BMJ 2020;368:m766

In this paper by Fan and colleagues (BMJ 2020;368:m331, doi:10.1136/bmj.m331, published 19 February 2020), the statement “The United Kingdom Medicines and Healthcare products Regulatory Agency advise that alternatives to clarithromycin and azithromycin should be prescribed during pregnancy” incorrectly implied that the Medicines and Healthcare products Regulatory Authority (MHRA) has issued advice on the relative use of macrolides during pregnancy. The Summaries of Product Characteristics, which are authorised by the MHRA, state that for clarithromycin, “use during pregnancy is not advised without carefully weighing the benefits against risk”; for azithromycin, “azithromycin should only be used during pregnancy if the benefit outweighs the risk”; and for erythromycin, “like all drugs erythromycin should be used in pregnancy only when clearly indicated” (see table 1 below). The authors acknowledge the support from CALIBER, led from the UCL Institute of Health Informatics. This study is based in part on data from the CPRD obtained under license. The interpretation and conclusions contained in this study are those of the authors alone.

Table 1

Statements from British National Formulary (BNF) and in Summaries of Product Characteristics (SPC) on the safety of specific macrolides during pregnancy

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