USE OF AMINOGLYCOSIDE ANTIBIOTICS IN PREGNANCY

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(Date of issue: August 2022, Version: 2)

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 Aminoglycosides is available at www.medicinesinpregnancy.org.

Summary

Aminoglycosides are bactericidal agents used topically as eye or ear drops, parenterally for serious infections, nebulised in the management of chronic pulmonary infection due to Pseudomonas aeruginosa in patients with cystic fibrosis, or orally for pre-operative sterilisation of the bowel. Those available in the UK include amikacin, gentamicin, neomycin, streptomycin, paromomycin, and tobramycin.

Ototoxicity and nephrotoxicity are recognised side effects of aminoglycosides, and theoretical risks exist following fetal exposure. Ototoxicity has also been reported following gestational streptomycin exposure. Susceptibility to aminoglycoside-induced deafness is genetically determined in some cases. Genetic testing for the common predisposing mitochondrial RNA mutation 1555A>G is available in the UK and could be considered for pregnant women requiring systemic aminoglycoside treatment to determine if the fetus might be a carrier.

Overall, there is no convincing evidence of a significantly increased risk of structural congenital anomaly following gestational exposure to aminoglycoside antibiotics as a class or for the individual aminoglycosides for which data are available. However, there is insufficient data to rule out an increased risk of congenital anomalies for any of the aminoglycosides. Limited data do not suggest an increased risk of low birth weight or preterm delivery. No studies have assessed the risk of miscarriage or intrauterine death. Systemic aminoglycoside use in pregnancy should therefore be reserved for indications where there are no suitable alternatives with adequate pregnancy safety data and should only be used if the benefit of treatment is expected to outweigh any small increased risks which may exist.

Maternal use of topical aminoglycoside preparations (eye or ear drops) does not generally result in high systemic concentrations and is not expected to be associated with an increased risk of adverse pregnancy or fetal outcome. Use may be considered during pregnancy where indicated.

Where possible, the results of culture and sensitivity tests should be available before making a treatment choice in accordance with local prescribing guidelines, and risk factors for aminoglycoside ototoxicity and nephrotoxicity should be assessed in each patient. If an aminoglycoside is indicated, gentamicin is the preferred choice during pregnancy as there is more documented experience of its use than for other aminoglycosides.

Exposure to aminoglycosides 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 full UKTIS monographs downloaded directly from TOXBASE.org to be sure you are using the most up-to-date version. The summaries of these monographs are openly available on UKTIS.org.

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.