USE OF MEPTAZINOL IN PREGNANCY

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(Date of issue: January 2016, 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.

Summary

Meptazinol is a centrally acting hexahydroazepine analgesic. It is currently licensed for the short-term treatment of moderate to severe pain, including post-operative pain, obstetric pain and pain associated with renal colic.

There are no published data on the therapeutic use of meptazinol in early pregnancy. All available data concerning meptazinol exposure in human pregnancy are provided from clinical trials investigating its use as an analgesic during labour, the majority comparing meptazinol to pethidine. Data concerning the risk of adverse pregnancy outcomes which may result from exposures during earlier stages of pregnancy are therefore unavailable. As meptazinol has mixed agonist and antagonist activity at opioid receptors, the potential for respiratory depression and neonatal withdrawal must be considered following maternal use close to delivery.

Neonates with symptoms consistent with those caused by prenatal opioid exposure, including post-delivery withdrawal, have been reported following meptazinol use during labour. However, these data may be confounded. A single study in a small number of exposed neonates (n=17) found no significant difference in one and five minute Apgar scores in comparison with an unexposed control group.

Collectively the results of studies comparing neonatal outcomes following labour analgesia with meptazinol in comparison with pethidine do not currently demonstrate improved neonatal outcomes among the meptazinol-exposed cohort.

Exposure to meptazinol at any stage of 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. Given the lack of data relating to exposure in early pregnancy, in such cases, detailed ultrasound scans should be considered to check morphological development.
                      
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.