USE OF ANTIDIABETICS IN PREGNANCY

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(Date of issue: February 2016, Version: 1)

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

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, nateglinide, repaglinide, exenatide, liraglutide, lixisenatide, alogliptin, linagliptin, saxagliptin, sitagliptin and vildagliptin, as well as the biguanides (metformin) and sulfonylureas (glibenclamide, gliclazide, glimepiride, glipizide, tolbutamide).

There are extremely limited data on the use of antidiabetic drugs other than metformin during pregnancy. Current data on these drugs consist of five case reports and post-marketing surveillance/clinical trials which document pregnancy outcomes for a total of 126 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 maternal and fetal adverse outcomes, therefore glycaemic control during pregnancy is of particular importance.

Current NICE recommendations suggest metformin (alone or with insulin) for the management of pre-existing diabetes in pregnancy. Gestational diabetes after the first trimester may be treated with metformin or glibenclamide (with or without concomitant insulin). For information on metformin and glibenclamide please see the separate monographs.

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 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.