USE OF OXYCODONE IN PREGNANCY

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(Date of issue: May 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.

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

Summary

Oxycodone is a semisynthetic opioid analgesic administered orally, intramuscularly or intravenously for the treatment of moderate to severe pain.

The available data concerning the fetal effects of maternal oxycodone use in pregnancy are limited, consisting of approximately 500 pregnancies described in four uncontrolled case reports and five controlled studies. One case report and one controlled study relate to recreational oxycodone exposure specifically.

The results of these studies do not currently indicate that maternal therapeutic use of oxycodone in early pregnancy increases overall congenital malformation rates in exposed offspring, but the available data are not sufficient to exclude an increase in risk. One retrospective case-control study suggested a possible association between pulmonary valve stenosis and first trimester therapeutic oxycodone exposure. As this finding was based on a small number of exposed pregnancies, confirmation in additional studies is required. One small study has assessed the risk of spontaneous abortion and found no evidence of an association with maternal therapeutic oxycodone use in the first trimester. No studies have investigated the risk of intrauterine death, neurodevelopmental impairment or cancer in the offspring following maternal use of oxycodone.

A single study identified an increased risk of preterm delivery and neonatal abstinence syndrome, but no effect on birth weight, among offspring of women reporting recreational oxycodone use in pregnancy. However, these data may be confounded by concomitant recreational exposures and maternal lifestyle factors.

Use of any opioid during pregnancy, particularly around the time of delivery, confers a risk of neonatal respiratory depression and neonatal withdrawal, both of which have been described following in utero oxycodone exposure.

Where oxycodone poisoning occurs in pregnancy, maternal toxicity is likely to be a major factor in determining any risk to the fetus. However, due to a lack of sufficient poisoning in pregnancy exposure data, an increased risk of adverse outcomes in the absence of maternal toxicity cannot currently be excluded. 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 oxycodone at any stage in 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. Enhanced fetal monitoring may be warranted during instances of maternal toxicity. Central nervous system (CNS) depression and fatality has been reported in neonates breastfed by mothers medicated with oxycodone; use in lactation is therefore not recommended.
                      
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.