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USE OF TRAMADOL IN PREGNANCY

Date of issue: January 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 tramadol use in pregnancy is available at www.medicinesinpregnancy.org.

Summary

Tramadol is an opioid receptor agonist with serotonergic and noradrenergic activity used in the management of moderate to severe pain.

The available published data concerning gestational tramadol exposure describe the outcomes of approximately 1900 exposed infants, with the majority of the data considering the risk of congenital malformation alone. Data considering the risk of other adverse pregnancy outcomes are highly limited.

Data regarding malformation risk are conflicting. A large prospective population-based study identified possible associations between first trimester tramadol exposure and modestly increased risks of ‘any relatively severe defect’, and more specifically, cardiovascular defects, isolated septum defects and talipes equinovarus (clubfoot). A smaller cohort study found no association between exposure and malformation in the offspring, therefore further data are required before any definitive conclusions can be drawn.

A single study has identified an increased risk of spontaneous abortion among women who used tramadol in early pregnancy, however further studies which consider the impact of confounding factors are required. There are no controlled data concerning the risk of intrauterine fetal death, preterm delivery, low birth weight, infant neurodevelopmental impairment or cancer following intrauterine tramadol exposure.

Use of tramadol near term may cause neonatal respiratory depression and long-term use may be associated with neonatal abstinence syndrome. Where exposure has occurred in the weeks preceding delivery, monitoring of the neonate in a unit with adequate neonatal facilities is advised.

Exposure to tramadol 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.
                    
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.