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Two reviews of GLP-1 receptor agonist use around pregnancy found no clear increase in most measured maternal or perinatal risks. Researchers said the evidence is limited and does not establish safety; current advice to stop treatment before planned conception remains unchanged.
Two reviews of GLP-1 receptor agonists used around pregnancy found no clear increase in most measured adverse outcomes, but the researchers said the findings do not establish that the drugs are safe during pregnancy. The results describe outcomes after exposure before conception or early in pregnancy. Current recommendations to stop treatment before planned conception remain unchanged.
A systematic review and meta-analysis of 10 studies covering more than 2.1 million pregnancies found no clearly detectable increase in miscarriage or intrauterine death, congenital anomalies, preterm birth, hypertensive disorders, gestational diabetes, or several measures of fetal growth and gestational weight gain among people exposed to GLP-1 drugs around conception. The comparison was with people who had not used the drugs.
The pooled estimate for preeclampsia was lower among those exposed, with an odds ratio of 0.87 (95% CI 0.78-0.98). The authors cautioned that this result came from just two datasets and should be interpreted carefully. They also said the overall evidence had limits, including differing definitions of drug exposure, possible residual confounding and few studies contributing data for some outcomes.
A second review, presented at the European Association for the Study of Diabetes annual meeting and published in Lancet Obstetrics, Gynaecology, & Women’s Health, examined data on more than 40,000 women, most of whom had type 2 diabetes. Across four studies, it found no increase in congenital anomaly risk when GLP-1 drugs were discontinued during the first trimester (risk ratio 1.02, 95% CI 0.96-1.08). Across two studies, early pregnancy loss was more common among exposed women, but the largest contributing study combined miscarriage and termination, making that result difficult to interpret.
Pregnancy Planning Guidance Holds
The findings concern people taking GLP-1 drugs who are planning a pregnancy or become pregnant while using them. The researchers said the results may inform discussions about inadvertent exposure, but they did not recommend continuing treatment during pregnancy. The studies found no clear increase in most measured outcomes, but their findings do not establish that the drugs carry no risk.
GLP-1 medicines are not approved for use during pregnancy. Drug labeling recommends stopping them at least two months before a planned conception, although the report notes that this guidance rests on limited human data. The first review’s authors said those recommendations should remain in place until stronger evidence is available. The second review’s team also advised stopping treatment if pregnancy occurs and stressed the role of contraception while taking the drugs.
The report describes limited evidence on GLP-1 use among women with type 1 diabetes, as well as for gestational diabetes and breastfeeding. These gaps leave uncertainty about potential benefits and risks across different stages of pregnancy and postpartum care.
Two Reviews, Different Evidence
The first review pooled research on outcomes across more than two million pregnancies and assessed exposure during the period around conception. Its authors reported that subgroup analyses based on the reason for taking a GLP-1 drug were consistent with the main findings. They nevertheless highlighted differences in how studies defined exposure and the possibility that other factors could affect the observed outcomes.
The second review focused on a separate group of studies, primarily involving women with type 2 diabetes, and assessed outcomes including congenital anomalies and early pregnancy loss. Its authors also developed an international consensus statement on GLP-1 use before, during and after pregnancy in women with diabetes. According to Claire Meek of the University of Leicester, the statement offers clinical targets and strategies to help women understand when and how to stop treatment safely.
As use of the drug class and its indications expands, inadvertent exposure around conception may become more common, the first review’s authors wrote. The studies examine past practice, however, and that may not fully reflect current prescribing or use. Their results therefore describe the evidence available in the studies, rather than resolving the safety question for every drug, patient group or stage of pregnancy.
“The findings may provide limited reassurance following inadvertent exposure before conception or during early pregnancy, but they should not be interpreted as supporting continued treatment during pregnancy.”
— Asma Khalil, MD, MSc, and colleagues
Safety Evidence Remains Limited
The reviews cannot establish whether GLP-1 drugs are safe during pregnancy. Their conclusions are constrained by the available studies, including differences in exposure definitions, potential confounding and small numbers of studies for some outcomes. The lower pooled estimate for preeclampsia rests on two datasets, while the early-loss result in the second review is hard to interpret because miscarriage and termination were combined in the largest contributing study.
The report does not provide enough detail to determine how findings apply to each individual GLP-1 drug, dose or patient group. It also says evidence is sparse for use in type 1 diabetes, gestational diabetes and lactation. Whether newer patterns of prescribing produce the same outcomes as the past practices captured by the studies is also unresolved.
Researchers Call for More Data
For now, the first review’s authors say recommendations to stop GLP-1 drugs before planned conception should remain unchanged. Meek said the consensus statement proposes strategies to help women understand when to stop treatment and how to do so safely; the report does not specify a single new clinical milestone for changing current guidance.
The consensus authors called for greater investment in women’s health research, regulatory changes that allow evidence to be generated while protecting women and unborn children, and mandatory reporting of sex-disaggregated data. More research would be needed to clarify risks across specific drugs and pregnancy stages, and to address the evidence gaps around type 1 diabetes and breastfeeding. Until those data are available, the reviews describe observed outcomes but do not support changing pregnancy prescribing advice.
Key Questions
Do the reviews show that GLP-1 drugs are safe during pregnancy?
No. They found no clear increase in most measured outcomes, but the researchers said the evidence is limited and does not establish safety. GLP-1 drugs are not approved for use during pregnancy.
What should someone do if pregnancy occurs while taking a GLP-1 drug?
The consensus team discussed in the report advised stopping treatment in early pregnancy. The report does not provide individual medical advice; patients should contact a qualified health professional about their circumstances and treatment.
How long before planned conception should treatment stop?
Drug labeling recommends stopping GLP-1 receptor agonists at least two months before planned conception. The report says that guidance is based on limited human data and that the review authors recommend keeping current advice in place.
What did the second review find about early pregnancy loss?
It found a higher rate of early pregnancy loss among exposed women across two studies. The researchers said the result was difficult to interpret because the largest contributing study combined miscarriage and termination.
Source: rss
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