USE OF FENTANYL IN PREGNANCY

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(Date of issue: April 2017, 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.

A corresponding patient information leaflet on fentanyl use in pregnancy is available at www.medicinesinpregnancy.org.

Summary

Fentanyl is a synthetic opioid analgesic approximately 100 times more potent than morphine. Fentanyl can be administered orally, intravenously, intranasally, topically (in the form of transdermal patches), epidurally, or intrathecally. 

Published data concerning the use of fentanyl during pregnancy consist of a small number of case reports. No congenital malformations were observed in the four reported infants exposed during the first trimester and the available data do not currently raise concerns about other adverse pregnancy outcomes or altered neurodevelopment in the child. However, data are too limited to permit an evidence-based assessment of these risks. Use of any opioid during pregnancy, particularly around the time of delivery, confers a risk of neonatal respiratory depression. Prolonged use of opioids throughout pregnancy may also result in neonatal withdrawal. Where there is a compelling clinical indication for administration of fentanyl in the management of maternal pain or another condition, then use in pregnancy may be considered but at the lowest effective dose for the shortest period possible and should involve discussion with the patient regarding the lack of human pregnancy data.

Exposure to fentanyl at any stage of pregnancy would not usually be regarded as medical grounds for termination of pregnancy. The need for additional fetal monitoring or prenatal investigations should be decided on a case-by-case basis. 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. Infants exposed to fentanyl in utero for extended periods and/or around the time of delivery should ideally be delivered in a unit with facilities for the treatment and support of neonatal opioid withdrawal.
                     
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.