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Date of issue: June 2024, Version: 4

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 relating to meptazinol exposure derive from clinical trials investigating its use as an analgesic during labour, the majority comparing meptazinol to pethidine. Data relating to 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/poor neonatal adaption syndrome must be considered following maternal use close to delivery. Infants exposed in utero should ideally be delivered in a unit with facilities to provide monitoring and treatment for these complications.

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 by concomitant risk factors, such as delivery complications or other maternal exposures throughout pregnancy or during delivery. A single small study found no significant difference in one and five minute Apgar scores between meptazinol-exposed and unexposed control neonates.

Collectively, studies do not indicate significant differences in neonatal outcomes between infants born to women who received meptazinol during labour and those born to women who received pethidine.

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 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 NHS health care professionals who are logged in.

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.

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