EXPOSURE TO MISOPROSTOL IN PREGNANCY

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(Date of issue: October 2016, 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

Misoprostol is a synthetic prostaglandin E1 analogue given orally for the prophylaxis and treatment of NSAID-induced gastric ulcers. It is also used vaginally to induce cervical ripening and initiate labour near term. At higher doses, misoprostol in sequential use with mifepristone, is used to induce medical termination of pregnancy up to nine weeks gestation and is also used off-licence for medical termination in later pregnancy.

Misoprostol exposure in early pregnancy is associated with a significantly increased risk of spontaneous abortion. Case series describe a spectrum of anomalies including cranial nerve palsies, limb defects, orofacial clefts, arthrogryposis, talipes, autism and intellectual disability in offspring where pregnancy was continued post-exposure. These anomalies are all features of Möbius syndrome for which an association with misoprostol exposure in early pregnancy has been demonstrated. It has been suggested that the critical period of teratogenic risk is between five and eight weeks of gestation, but this is not universally accepted. Increased risk of intrauterine death and reduced birth weight following gestational misoprostol exposure has also been observed in some studies. Neurodevelopment has not been systematically studied in infants exposed to misoprostol. It is uncertain whether autism and neurodevelopmental anomalies are more common in individuals with Möbius syndrome following misoprostol exposure than in those with Möbius syndrome in the absence of misoprostol exposure. 

Due to the known risks the manufacturer advises that use of misoprostol for the prophylaxis and treatment of NSAID-induced gastric ulcers should be avoided in women of childbearing age unless pregnancy has been excluded.

Exposure to misoprostol in early pregnancy has been associated with an increased risk of fetal malformations, therefore additional fetal monitoring may be warranted in ongoing pregnancies. Cranial nerve defects, which have been associated with in utero misoprostol exposure, are unlikely to be detected by ultrasound examination but should be suspected if limb anomalies or arthrogryposis are observed. Other risk factors may also 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. When misoprostol has been used as an abortifacient, completeness of the abortion process should be confirmed.

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.