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 biguanide oral hypoglycaemics or insulin. As glibenclamide is a long-acting hypoglycaemic agent, there is a risk of maternal hypoglycaemia.
Most of the data for in utero glibenclamide exposure relates to late pregnancy treatment of gestational diabetes mellitus (GDM). No evidence of increased risk of maternal hypoglycaemia, pre-eclampsia, shoulder dystocia, fetal/neonatal risks of preterm birth, NICU admission, neonatal hypoglycaemia or birth injury has been presented.
Use of glibenclamide may be considered in pregnancy where clinically indicated, however experience of use within the first trimester is currently too limited to rule out any possibility of an increased risk of adverse pregnancy outcome.
Exposure to glibenclamide at any stage in pregnancy would not usually be regarded as medical grounds for termination of pregnancy or any additional fetal monitoring.
Please report ALL cases of drug and/or chemical exposure in pregnancy to UKTIS by telephoning the service on 0844 892 0909 or by printing and completing a pregnancy reporting form, providing as many patient identifiers as possible to enable follow up of pregnancy outcome. This vital information enables UKTIS to provide evidence-based advice for future enquiries and to conduct surveillance of potential and known teratogens.
For case specific advice please contact UKTIS on 0844 892 0909.