USE OF BACLOFEN IN PREGNANCY

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(Date of issue: January 2019, 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.

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

Summary

Baclofen is a gamma-aminobutyric acid (GABA) agonist licensed for oral or intrathecal administration to alleviate spasticity of voluntary muscle in patients with multiple sclerosis, spinal cord lesions, cerebral palsy, cerebrovascular accidents, traumatic head injury and meningitis.

Data on the use of baclofen in human pregnancy are derived from one small cohort study (presented in abstract only), case reports and two small case series (one presented only in abstract), and as such, are too limited to accurately assess risks to the infant or pregnancy. An increased risk of congenital malformation following in utero exposure has been reported by a small cohort study, however, no pattern of defects was observed and due to the small numbers of cases, consequent wide confidence intervals and lack of consideration of the impact of concomitant risk factors, the conclusions that can be drawn from this single study are limited. No evidence of an increased risk of miscarriage was provided from a small cohort study. There are insufficient data to assess the risk of intrauterine death, low birth weight, preterm delivery and adverse neurodevelopmental effects. Further research is therefore required.

Neonatal withdrawal has been reported following maternal use of oral baclofen. Delivery in a unit with adequate neonatal facilities is therefore advised if maternal use has occurred in the weeks prior to delivery.

Due to the lack of safety data the need for additional fetal monitoring needs to be considered 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.