USE OF ANTISPASMODICS IN PREGNANCY

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(Date of issue: May 2017, 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.

Summary

The non-muscarinic antispasmodics mebeverine hydrochloride, alverine citrate and peppermint oil are direct relaxants of smooth muscle in the gastrointestinal tract and are used for the symptomatic relief of irritable bowel syndrome where non-pharmacological interventions are inadequate. Alverine citrate is also used in the treatment of diverticular disease of the colon and dysmenorrhoea, due to its direct relaxant effects on uterine smooth muscle.

There are no adequate published data available to assess the potential teratogenic or fetotoxic effects of mebeverine hydrochloride, alverine citrate or pharmaceutical doses of peppermint oil. It is therefore not possible to provide an assessment of the risk posed to the fetus following maternal use of these products during pregnancy.

Based on the lack of published evidence to support the safe use of mebeverine hydrochloride, alverine citrate or therapeutic doses of peppermint oil in human pregnancy, use during pregnancy is not recommended unless there is a compelling clinical need where benefit of use is considered to outweigh any potential risks to the fetus.

Exposure to antispasmodics 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.