USE OF RIBAVIRIN IN PREGNANCY

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(Date of issue: April 2020, Version: 3)

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 ribavirin use in pregnancy is available at www.medicinesinpregnancy.org.

Summary

Ribavirin is a synthetic nucleoside antiviral agent available in oral and aerosolised formulations. It is currently licensed to treat chronic hepatitis C in combination with interferon alfa-2b or peginterferon alfa-2b (oral), and for the treatment of respiratory syncytial virus (RSV) bronchiolitis in infants and children (aerosol). Unlicensed indications for ribavirin include influenza, severe acute respiratory syndrome (SARS), and adenoviral pneumonia.

Ribavirin is known to accumulate within cells, and is eliminated slowly from non-plasma compartments. As it has been shown to be teratogenic, embryotoxic, and mutagenic in various animal species at doses within the human therapeutic range, the advice from the manufacturers is that conception should be delayed for four months following discontinuation of therapy. Its intentional use during pregnancy has also generally been restricted or reserved for cases of severe maternal illness. As a result the available data are both highly limited and heavily confounded.

The available data currently consist of uncontrolled case reports/series which document the outcomes of approximately 165 direct maternal exposures, only 18 of which occurred in the first trimester. In addition, there are data from approximately 146 cases of indirect maternal exposure.  Although cases of congenital malformation, miscarriage, stillbirth, preterm delivery and low birth weight have been reported following ribavirin exposure in pregnancy, the data are too limited and not in a format to permit an evidence-based assessment of any increased risk of adverse effects on the developing fetus.

No published studies have investigated maternal or fetal outcomes of pregnant women occupationally exposed to ribavirin. Exposure estimation data suggest that only a small amount of ribavirin would ever reach the maternal systemic circulation, and therefore the fetus, following occupational exposure. However, due to a lack of adequately controlled data, it is currently not possible to state conclusively that there is no increased risk of adverse pregnancy outcomes. If occupational exposure is unavoidable, then adequate precautions should be taken to minimise exposure.

Ribavirin exposure at any stage in pregnancy would not usually be regarded as medical grounds for termination of pregnancy. 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. For cases of severe maternal illness, where ribavirin is considered to be the most effective treatment option, ribavirin should not be withheld on the account of pregnancy. Given the limited data, the possibility of an increased risk of adverse pregnancy outcomes following maternal ribavirin exposure cannot be excluded, and the need for additional fetal monitoring should be considered on a case-by-case basis.

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.