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Date of issue: December 2021, Version: 3

Glibenclamide (glyburide) 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.

Data on the use of glibenclamide in pregnancy consist of >9,500 exposures; however, glibenclamide is used in the management of gestational diabetes, which most commonly occurs in the second or third trimester; therefore, first trimester exposure data are lacking and an increased risk of congenital malformation or miscarriage cannot be excluded. 

Data regarding risk of large for gestational age (LGA) or macrosomia in the infant and neonatal hypoglycaemia following glibenclamide treatment of gestational diabetes when compared to insulin and/or metformin are conflicting, possibly as a result of a lack of efficacy resulting in 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, preterm delivery, neonatal jaundice/hyperbilirubinaemia or admission to a neonatal intensive care unit (NICU).

Current recommendations from The National Institute for Health and Care Excellence (NICE) suggest metformin (alone or in combination with insulin) for the management of pre-existing or gestational diabetes. For information on metformin please see the separate monograph.

Women with pre-existing diabetes who are planning to become pregnant should be advised to take high-dose folic acid (5mg daily) prior to conception and throughout the first trimester.

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 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 NHS health care professionals who are logged in.

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.

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