USE OF GLIBENCLAMIDE IN PREGNANCY

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(Date of issue: August 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.

Summary

Glibenclamide is an oral sulfonylurea hypoglycaemic agent indicated in the treatment of non-insulin-dependent diabetes in patients who fail to respond to dietary measures alone. Glibenclamide may be used in conjunction with metformin or insulin. Glibenclamide may be considered in the treatment of gestational diabetes where metformin is ineffective or not tolerated, and where treatment with insulin is declined.

Data on the use of glibenclamide in pregnancy consist of >9,500 exposures, although as glibenclamide is used in the management of gestational diabetes, first trimester exposure data are lacking and an increased risk of congenital malformation or spontaneous abortion cannot be excluded. 

Data regarding risk of large for gestational age or macrosomia in the infant, neonatal hypoglycaemia and admission to a neonatal intensive care unit with glibenclamide treatment of gestational diabetes when compared to insulin and/or metformin, are conflicting, possibly as a result of confounding from variation in maternal obesity and glycaemic control, both of which are known to significantly affect these outcomes. No increased risks were identified for intrauterine death or preterm delivery.

Exposure to glibenclamide at any stage of pregnancy would not usually be regarded as medical grounds for termination of pregnancy or any additional fetal monitoring. However, women with diabetes may require additional monitoring of fetal growth and amniotic fluid volume irrespective of medication. 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.