USE OF BUPRENORPHINE IN PREGNANCY

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(Date of issue: September 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 buprenorphine use in pregnancy is available at www.medicinesinpregnancy.org.

Summary

Buprenorphine is a semi-synthetic opioid derived from the morphine alkaloid thebaine which has mixed agonist-antagonist properties. It is typically administered intramuscularly, intravenously, by sublingual tablet, or via transdermal patch. Buprenorphine is used for the treatment of moderate to severe pain and, when combined with psychological treatment, as a substitution treatment in the management of opioid dependence.

Several animal studies have found adverse fetal effects following maternal exposure to buprenorphine. The limited available data relating to use of buprenorphine during human pregnancy have not identified increased risks of congenital malformation, preterm delivery, or low infant birth weight but are likely to be confounded, and comparisons are often to cohorts of women on other opioid substitution therapies. Data on rates of intrauterine death following buprenorphine exposure do not raise concern but are too limited to state definitively that no increased risk exists. Data on the rates of spontaneous abortion and adverse neurodevelopment are too limited to allow an evidence-based risk assessment.

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 result in neonatal withdrawal and this has been documented specifically in buprenorphine-exposed infants. Infants gestationally exposed to buprenorphine should therefore ideally be delivered in a unit with facilities to provide monitoring and treatment for these conditions.

Where buprenorphine overdose occurs in pregnancy, maternal toxicity is likely to be a major factor in determining risk to the fetus. If use of an antidote (e.g. naloxone) is required in the management of maternal toxicity it should not be withheld on account of pregnancy.

Exposure to buprenorphine at any stage in pregnancy would not usually be regarded as medical grounds for termination of pregnancy. Additional fetal monitoring may be required in pregnancies complicated by severe pain or opioid addiction on a case-by-case basis. 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.

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.