Women, particularly those with diabetes, and many of reproductive age, make up the vast majority of users of GLP-1 receptor agonists (RAs), yet the substantial gaps in research addressing the safety of the drugs surrounding pregnancy are striking.

To provide guidance on key issues based on what is known and on expert consensus until more robust evidence emerges, a first-of-its-kind international consensus statement has been issued, taking on key issues ranging from preconception use to postpartum breastfeeding.

The statement aims “to guide clinical care in areas of current extreme uncertainty,” said first author Claire L. Meek, PhD, of the Leicester Diabetes Centre, Leicester General Hospital, University of Leicester, Leicester, UK, who presented the recommendations at the European Association for the Study of Diabetes (EASD) 2026 Annual Meeting.

To help address these gaps, “we call for greater investment in women’s health research to meet the scale of the estimated $70 billion market share that pharma has with these drugs,” she added.

The report includes recommendations from a panel of 33 international obstetric and diabetes specialists, in addition to input from 60 women who have lived experience of diabetes, including 40 with type 2 diabetes (T2D), 10 with type 1 diabetes (T1D), and 10 with gestational diabetes.

The consensus statement is one of four papers published as a series in The Lancet highlighting the need for better research on GLP-1 RA drugs in women.

“Women with preexisting or gestational diabetes are a distinct clinical population with important differences in baseline risk and potential benefit,” the authors noted in the report. However, data on safety and efficacy of GLP-1 RAs surrounding pregnancy, specifically in women with diabetes, is scant, with many studies focusing on broader cohorts that mix populations of obesity and diabetes.

Meta-analysis Offers Insights, but Low-Quality Evidence

The prevalence of diabetes in pregnancy is increasing globally, and current guidelines recommend the use of GLP-1 RAs for the control of diabetes as well as weight management in the preconception period up to 2 months before pregnancy, but not during pregnancy itself, the study authors noted.

To further investigate the question, Meek and colleagues conducted a meta-analysis of studies with a combined total of 49,596 patients of reproductive age who were diagnosed with T1D, T2D, or gestational diabetes, and were exposed to GLP-1 RAs up to 12 months before pregnancy, during pregnancy, or in the postpartum periods.

While 1806 studies meeting the search criteria were identified, only 23 had original data looking at the safety of treatment with GLP-1 RAs in the defined periods among women with diabetes, and only seven of those had data that could be used in the analysis.

Those figures alone “already tell us quite a lot about the state of women’s health evidence in this field,” Meek lamented.

Risk for Congenital Anomalies, Miscarriage

Key notable findings from the analysis, with the caveat of generally being assessed as “low certainty evidence” due to limitations, include encouraging results suggesting that the discontinuation of GLP-RAs in the first trimester shows no increased risk for congenital anomalies, compared with no GLP-1 RA exposure in four studies with a combined total of 42,144 GLP-1 RA-exposed women (risk ratio [RR], 1.02).

The issue is of high concern, as many women inadvertently conceive while using GLP-1 RAs, and may not discontinue until discovering in their first trimester that they are pregnant, Meek and colleagues pointed out.

The review did show data indicating that miscarriage or termination was more common among women exposed to GLP-1 RAs than those not exposed to the drugs in two studies of 41,046 patients combined (RR, 1.31); however, Meek cautioned that those results were “difficult to interpret because the largest study lumped together terminations and miscarriages.”

“No other data has suggested an increase in miscarriage rates, and so from my point of view I don’t think this is definitive evidence,” she added.

In terms of further outcomes of interest, data from the studies point to the safety of GLP-1 RAs when it comes to preterm birth, stillbirth, cesarean section, hypertensive disorders, or having small for gestational age births; however, again, the authors noted that the studies were small and retrospective and therefore had low-quality evidence.

Consensus Recommendations

Based on the evidence that could be used, as well as their expert opinion and consensus, the panel’s recommendations addressed many key areas lacking in more robust studies.

For Preconception Care in T2D

• In line with published evidence, the panel agreed that GLP-1 RAs are likely to be beneficial for improving glucose and weight preconception in women with T2D.
• Contraception is strongly recommended during GLP-1 RAs use and after medication discontinuation in line with the product instructions.
• If patients inadvertently conceive while using GLP-1 RAs, discontinuation of the medication is recommended as soon as patients become aware of the pregnancy.

Targets Proposed

• While supporting the benefits of GLP-1 RAs in the preconception period, the panel recommended key targets for use in the period, including normal A1c levels less than 6.5%, and a BMI of less than 25, or weight loss of 5%-10% of total body weight for women who are overweight or obese.
• The panel further recommended use of GLP-1 RAs for approximately 12-18 months in the preconception period for maximal benefits, while noting the need for specific strategies for discontinuing the drugs in pregnancy planning.

For Postpartum Care in T2D

• Importantly, while breastfeeding is highly recommended in women with diabetes, the panel concludes that “there is insufficient data on safety to support any use of GLP-1 RAs during lactation.”
• “Among women who choose to use GLP-1 RAs during breastfeeding or who have unacceptable levels of hyperglycemia or weight gain on insulin, GLP-1 RAs should be used at the lowest effective dose,” the statement authors added.

For Women With T1D

• While GLP-1 RAs show similar potential benefits in women with T1D before and after pregnancy, “there is virtually no evidence in this population; initiation should only be considered where the potential benefits outweigh the risks,” the panel stated.
• However, additional safety requirements were suggested, including the appropriate adjustment of insulin dosing to prevent hypoglycemia due to improved insulin sensitivity, and reviewing insulin dosing and pump settings every month during the dose escalation phase.

For Women With Previous Gestational Diabetes

• “GLP-1 receptor agonist use for at least 12 months should be considered postnatally after gestational diabetes, and before the next pregnancy,” the consensus statement recommended.
• Treatment with GLP-1 RAs can potentially provide rapid and sustained postnatal weight loss in women after a pregnancy with gestational diabetes, the panel noted.
• While evidence is currently insufficient, “theoretically, weight loss is likely to reduce future type 2 diabetes risk and might prevent gestational diabetes recurrence in future pregnancies,” they added.

Guidance Should Help With ‘Difficult Choices’

Further commenting to Medscape Medical News, Meek, who runs one of the largest diabetes in pregnancy and pregnancy planning services in the UK, said the recommendations will be relevant for many practitioners in the field.

“These issues face my patients daily, and we have had to navigate some difficult choices together,” she said.

Another notable point that should be of high interest to clinicians and patients alike include new recommendations for patients with T1D and gestational diabetes, Meek said.

“My patients with type 1 diabetes will be delighted for the first official recognition that GLP-1 RAs are useful in pregnancy planning in that group of women,” she said.

Furthermore, “we recommended 12 months of GLP-1 RAs after gestational diabetes — which is also a huge advance, and something the consensus panel was virtually unanimous about.”

‘Massive’ Disconnect Between GLP-1 RA Use and Safety Data in Pregnancy

Commenting on the report, Lene Ringholm, PhD, an associate professor with the Department of Clinical Medicine, University of Copenhagen, and a consultant at the Center for Pregnant Women with Diabetes at Rigshospitalet, Copenhagen, Denmark, noted that the analysis “provides a much-needed framework to guide GLP-1 RA use while navigating peri-pregnant safety.”

“The significance of this work lies in addressing a massive clinical mismatch: real-world prescription of GLP-1 receptor agonists is surging, yet safety data before, during, and after pregnancy remain scarce,” she said.

Ringholm said she found the findings of no increased risk for congenital malformations associated with GLP-1 RAs to be “reassuring,” but noted that real-world data on the effects of pre-pregnancy and pregnancy exposure, with well-matched unexposed control groups and proper adjustments are needed “to eliminate residual confounding.”

Among the more challenging issues is that of breastfeeding, she noted.

“The suggestion to consider GLP-1 RAs at the lowest effective dose during breastfeeding for women with unacceptable hyperglycemia or weight gain on insulin is controversial but may be necessary for some women,” she said.

While the drug manufacturers recommend avoidance of GLP-1s during breastfeeding, “forcing a choice between diabetes and weight management vs early breastfeeding cessation creates an ethical dilemma,” said Ringholm, noting the acknowledgement in the consensus statement that robust long-term infant safety data are still missing.

Ultimately, the findings underscore that “there is an urgent and immediate need for robust research to address the aforementioned uncertainties with regards to the health of women with diabetes and their children,” Ringholm said.

“We need to examine issues such as rebound gestational weight gain after medication discontinuation before pregnancy, its potential impact on fetal growth, and the observed signal of increased risk of pregnancy loss,” she added.

Until then, diabetes caregivers “must prioritize counseling women of reproductive age on the importance of pregnancy planning,” she said. “A potential pregnancy intention can easily be addressed in routine care by asking a simple screening question, such as: ‘Would you like to become pregnant in the next year?’ whenever clinically appropriate.”

Meek had no disclosures to report. Ringholm reported receiving research funding from Novo Nordisk.