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Two reviews found no clearly detectable increase in several adverse pregnancy outcomes linked to GLP-1 drug exposure around conception. The findings do not establish safety or support treatment during pregnancy, and researchers say current advice to stop before planned conception should stand.
Two reviews of GLP-1 drug exposure around pregnancy found no clearly detectable increase in several adverse maternal or perinatal outcomes, but researchers said the evidence is too limited to establish safety. The findings do not support continued treatment during pregnancy. Researchers said current advice to stop treatment before planned conception should remain in place.
A systematic review and meta-analysis of 10 studies covering more than 2.1 million pregnancies found no clear 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 women who used GLP-1 drugs around conception. The comparison was with women who had not used the drugs.
The review found a lower pooled estimate for preeclampsia among exposed women: an odds ratio of 0.87, with a 95% confidence interval of 0.78 to 0.98. That result came from only two datasets. Asma Khalil of City St George’s University of London and colleagues said it should be interpreted cautiously, and warned that the review does not establish that the drugs are safe in pregnancy.
A second review, presented at the European Association for the Study of Diabetes meeting and published in Lancet Obstetrics, Gynaecology, & Women’s Health, examined data on more than 40,000 women, primarily with type 2 diabetes. It found no increase in congenital anomaly risk when treatment was discontinued during the first trimester. However, early pregnancy loss was more common in the exposed group in two studies; the researchers said interpretation was difficult because the largest study combined miscarriages and terminations.
Guidance Still Favors Stopping Before Conception
GLP-1 drugs are used by a growing number of people. The first review found no clearly detectable increase in the measured outcomes among women exposed around conception.
The findings do not establish safety. The drugs are not approved for use during pregnancy, and the authors said the results do not support continued treatment while pregnant. Drug labeling advises stopping at least two months before planned conception, although the guidance rests on limited human data. The reviews do not change that advice.
Two Reviews, Different Study Groups
The first analysis pooled studies of exposure during the periconceptional period, the time around conception. Its authors noted differences in how studies defined exposure, as well as possible residual confounding and the small number of studies available for some outcomes. Subgroup analyses by the reason for taking the drug were consistent with the main analysis.
The second review focused largely on women with type 2 diabetes and included studies where GLP-1 treatment was stopped during the first trimester. Its early pregnancy loss estimate combined miscarriage and termination in the largest contributing dataset, which limits what can be concluded about miscarriage alone. The reviews address related questions, but their populations and outcome measures differ.
After the second review, Claire Meek of the University of Leicester and colleagues developed what they described as the first international consensus statement on GLP-1 use before, during and after pregnancy in women with diabetes. The recommendations also address contraception, stopping treatment if pregnancy occurs, and areas where evidence remains sparse, including type 1 diabetes and breastfeeding.
“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 and colleagues
Safety Evidence Remains Limited
Neither review can show that GLP-1 drugs are safe during pregnancy. The first analysis was limited by differing exposure definitions, possible residual confounding and few studies for some outcomes. The second found a higher rate of early pregnancy loss in exposed women, but its combined miscarriage and termination measure makes the result difficult to interpret.
It is also unclear how well findings based on past use reflect current prescribing. Evidence is especially scarce for people with type 1 diabetes, for use around gestational diabetes, and during lactation. The available findings do not settle whether any observed differences were caused by the medication or other factors.
Researchers Call for Better Pregnancy Data
For now, the first review’s authors said current recommendations to discontinue GLP-1 drugs before conception should remain unchanged. Meek said contraception is strongly recommended while taking the drugs and that treatment should stop in early pregnancy if conception occurs. People planning pregnancy or who become pregnant while taking a GLP-1 drug can discuss next steps with their prescribing clinician.
The consensus authors called for more investment in women’s health research and regulatory changes that allow evidence to be gathered while protecting patients and unborn children. They also advocated mandatory reporting of sex-disaggregated data. No timeline for new studies or changes to drug labeling was provided in the source report.
Key Questions
Do the studies show GLP-1 drugs are safe during pregnancy?
No. The reviews found no clear increase in many measured outcomes, but the authors said the evidence does not establish safety or support continued treatment during pregnancy.
What should someone do if planning a pregnancy?
Drug labeling advises stopping GLP-1 treatment at least two months before planned conception. The review authors said current recommendations should remain unchanged; patients can discuss timing with their prescribing clinician.
What did the second review find about early pregnancy loss?
It reported a higher rate of early pregnancy loss among exposed women across two studies. The researchers said the result is difficult to interpret because the largest study combined miscarriage and termination.
Is there evidence about GLP-1 drugs while breastfeeding?
Data remain scarce. The consensus authors advised women using a GLP-1 drug while breastfeeding to stick to the lowest effective dose, according to the source report.
Source: rss
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