USE OF ANTIDIABETICS IN PREGNANCY
Date of issue: March 2021, Version: 2
Antidiabetic drugs are used for the treatment of type 2 diabetes mellitus in conjunction with diet and exercise and act via several mechanisms. Currently available antidiabetic drugs include: pioglitazone, canagliflozin, dapagliflozin, empagliflozin, repaglinide, exenatide, liraglutide, lixisenatide, alogliptin, linagliptin, saxagliptin, sitagliptin and vildagliptin, as well as the biguanides (metformin) and sulfonylureas (glibenclamide[discontinued by the manufacturer in the UK], gliclazide, glimepiride, glipizide and tolbutamide).
The biguanides and sulfonylureas are not included in this document; please see the individual monographs where available.
There are extremely limited data on the use of antidiabetic drugs other than metformin during pregnancy. Current data on these drugs consist of six case reports and post-marketing surveillance/clinical trials which document pregnancy outcomes for a total of 206 exposed pregnancies, although details are limited and it is not currently possible to provide an evidence-based assessment of fetal risk for any pregnancy outcome. Even with good maternal glycaemic control, infants of diabetic mothers remain at increased risk of congenital malformation. Increasing maternal hyperglycaemia is directly correlated with both adverse maternal and fetal outcomes; therefore, glycaemic control during pregnancy is of particular importance.
Current National Institute for Health and Care Excellence (NICE) recommendations 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 oral antidiabetics at any stage in pregnancy would not usually be regarded as medical grounds for termination of pregnancy. Due to the lack of data, and as other risk factors may be present in individual cases which may independently increase the risk of adverse pregnancy outcome, the need for additional fetal monitoring should be assessed on a case-by-case basis. 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.