USE OF AMOXICILLIN IN PREGNANCY

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(Date of issue: September 2014, Version: 2.1)

This is a UKTIS monograph for use by health care professionals. For case-specific advice please contact UKTIS on 0344 892 0909. To report an exposure please download and complete a pregnancy reporting form. Please encourage all women to complete an online reporting form.

A corresponding patient information leaflet on amoxicillin use in pregnancy is available at www.medicinesinpregnancy.org.

Summary

Amoxicillin is a broad spectrum β-lactam antibiotic used in the treatment of susceptible bacterial infections, principally respiratory, middle ear and urinary tract infections. 

There are over 25,000 published cases of amoxicillin use during pregnancy, subsets of which have been analysed for various outcomes. No increased risks of spontaneous abortion, overall congenital malformation, intrauterine death, or neonatal complications were identified in these analyses. Two studies found a significant increase in cleft lip/palate, however this was not replicated in a further two studies. As the background risk for oral clefts is ~ 1 to 2 per 1,000 live births, even with a significant increase in relative risk, the absolute risk following first trimester amoxicillin exposure is likely to be low. Although one study found an increased risk of low birth weight and preterm delivery, this was not replicated in further studies.

Exposure to amoxicillin at any stage in pregnancy would not usually be regarded as medical grounds for termination of pregnancy or any additional fetal monitoring. However, other risk factors may be present in individual cases which may independently increase the risk of adverse pregnancy outcome. Clinicians are reminded of the importance of consideration of such factors when performing case-specific risk assessments.

This document is regularly reviewed and updated. Only use UKTIS monographs downloaded directly from TOXBASE.org or UKTIS.org to be sure you are using the most up-to-date version.

This is a summary of the full UKTIS monograph for health care professionals and should not be used in isolation. The full UKTIS monograph and access to any hyperlinked related documents is available to health care professionals at www.toxbase.org.

If you have a patient with exposure to a drug or chemical and require assistance in making a patient-specific risk assessment, please telephone UKTIS on 0344 892 0909 to discuss the case with a teratology specialist.

If you would like to report a pregnancy to UKTIS please click here to download our pregnancy reporting form. Please encourage all women to complete an online reporting form.

Disclaimer: Every effort has been made to ensure that this monograph was accurate and up-to-date at the time of writing, however it cannot cover every eventuality and the information providers cannot be held responsible for any adverse outcomes of the measures recommended. The final decision regarding which treatment is used for an individual patient remains the clinical responsibility of the prescriber. This material may be freely reproduced for education and not for profit purposes within the UK National Health Service, however no linking to this website or reproduction by or for commercial organisations is permitted without the express written permission of this service. This document is regularly reviewed and updated. Only use UKTIS monographs downloaded directly from TOXBASE.org or UKTIS.org to ensure you are using the most up-to-date version.