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Two systematic reviews — one covering over 2.1 million pregnancies, another over 40,000 women with type 2 diabetes — found no clear increase in major adverse pregnancy outcomes with periconceptional GLP-1 exposure. However, researchers caution the findings do not establish safety, and current advice to stop GLP-1 drugs before conception remains unchanged.
Two systematic reviews and meta-analyses found no clearly detectable increase in major adverse maternal or perinatal outcomes among women exposed to GLP-1 receptor agonists around conception, but the researchers stressed the findings do not establish safety and that current guidance to stop the drugs before pregnancy should remain unchanged. The studies, one spanning more than 2.1 million pregnancies and the other more than 40,000 women with mostly type 2 diabetes, were presented at the European Association for the Study of Diabetes (EASD) annual meeting and published in the journals Med and Lancet Obstetrics, Gynaecology, & Women’s Health.
The larger analysis, led by Asma Khalil, MD, MSc, of City St George’s University of London, pooled data from 10 studies covering more than 2.1 million pregnancies. It found no clear increase in miscarriage or intrauterine death, congenital anomalies, preterm birth, hypertensive disorders of pregnancy, gestational diabetes, small- or large-for-gestational-age infants, fetal growth restriction, or excess gestational weight gain among women who used GLP-1 drugs in the periconceptional period compared with unexposed women. The review also found a lower pooled estimate for preeclampsia (OR 0.87, 95% CI 0.78-0.98, P=0.02), but the authors said this result rested on only two datasets and “should be interpreted cautiously.”
The second meta-analysis, led by Claire Meek, PhD, of the University of Leicester, focused on more than 40,000 women who primarily had type 2 diabetes. It found no increase in congenital anomaly risk when GLP-1 drugs were discontinued during the first trimester (RR 1.02, 95% CI 0.96-1.08 across four studies). However, early pregnancy loss — miscarriage or termination before 14-22 weeks — was more common among exposed women (RR 1.31, 95% CI 1.26-1.35 across two studies). The researchers noted this finding was difficult to interpret because the largest contributing study combined miscarriage and termination data. GLP-1 use was not associated with any other safety or efficacy outcomes measured.
Alongside the analysis, Meek and colleagues produced what they described as the first international consensus statement on GLP-1 drug use before, during, and after pregnancy in women with diabetes. The statement sets clinical monitoring targets for preconception use, recommends strategies to help women stop the drugs safely, and advises that contraception remains strongly recommended while taking GLP-1 medications.
Limits of the Findings
GLP-1 drugs such as semaglutide are not approved for use during pregnancy, and drug labeling recommends stopping them at least two months before planned conception — guidance that has relied on limited human data. Khalil and colleagues noted that as prescriptions and approved indications for the drug class have grown, inadvertent exposure before conception or in early pregnancy has likely increased, and they identified more robust safety evidence as a research need.
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,” Khalil’s group wrote. “Until more robust evidence is available, current recommendations to discontinue GLP-1 receptor agonists before conception should remain unchanged.”
The consensus statement also addresses open clinical questions. It suggests GLP-1 drugs could be considered in the preconception period and postnatally for women with gestational diabetes, with up to 12 months of use recommended, and advises breastfeeding women who take the drugs to remain on the lowest effective dose, citing scarce lactation data.
The Evidence Gap Behind Current Labeling
GLP-1 receptor agonists were originally developed for type 2 diabetes and have since become widely prescribed for obesity and other conditions. Because pregnant women are typically excluded from drug trials, human safety data around pregnancy have remained limited, and regulators have relied largely on animal studies when crafting labeling language. Clinicians have consequently had little guidance when patients conceive while taking the drugs, a situation the researchers said has become more frequent as prescriptions have grown.
The new meta-analyses represent the largest pooled evidence to date on the question, and the consensus statement is intended to standardize prescribing decisions for women with diabetes across the preconception, pregnancy, and postnatal periods, including in type 1 diabetes, where Meek noted there is “a lot of interest from women but almost no evidence.”
“The results 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, of City St George’s University of London, and colleagues
What the Pooled Data Cannot Prove
Khalil’s team emphasized that the findings do not establish safety. The evidence is limited by inconsistent definitions of exposure across studies, residual confounding, and the small number of studies contributing to several outcomes. The apparent reduction in preeclampsia risk was based on only two datasets and requires cautious interpretation.
In Meek’s analysis, the higher rate of early pregnancy loss among exposed women is difficult to interpret because the largest contributing study combined miscarriage and termination in a single outcome. Data on GLP-1 use during lactation remain scarce, evidence in type 1 diabetes is nearly absent, and there is no direct evidence in gestational diabetes. Tan also cautioned that observational studies of past practice may not reflect how the drugs are used today.
Research and Prescribing Changes Ahead
The new international consensus statement is expected to guide clinicians on GLP-1 prescribing before, during, and after pregnancy in women with diabetes, including monitoring targets for preconception use and safe discontinuation strategies. Meek and colleagues are calling for mandatory reporting of sex-disaggregated data in future studies and regulatory changes that would allow evidence generation while protecting maternal and fetal safety. In the meantime, guidance remains unchanged: women planning pregnancy should stop GLP-1 drugs at least two months before conception, contraception is strongly recommended while taking them, and treatment should stop in early pregnancy if conception occurs. Women with questions about their own treatment should consult their healthcare provider before making changes.
Key Questions
Is it safe to take GLP-1 drugs during pregnancy?
GLP-1 drugs are not approved for use during pregnancy. The new studies found no clearly detectable increase in major adverse outcomes with periconceptional exposure, but the authors state this does not establish safety, and they do not support continuing treatment during pregnancy.
What should I do if I become pregnant while taking a GLP-1 drug?
According to the consensus statement, treatment should stop in early pregnancy if conception occurs. The researchers say the new findings may offer limited reassurance after inadvertent exposure, but anyone in this situation should contact their healthcare provider promptly.
How long before trying to conceive should GLP-1 drugs be stopped?
Current drug labeling recommends discontinuing GLP-1 receptor agonists at least two months before planned conception, though the researchers note this guidance is based on limited human data.
Did the studies find any increased risks?
One analysis found early pregnancy loss (miscarriage or termination under 14-22 weeks) was more common among exposed women (RR 1.31), but the researchers said this was hard to interpret because the largest study combined miscarriage and termination. A lower preeclampsia estimate was also deemed unreliable due to limited data.
Can GLP-1 drugs be used while breastfeeding?
Data on lactation remain scarce. The consensus statement advises women using GLP-1 drugs while breastfeeding to remain on the lowest effective dose, and to discuss their situation with a healthcare provider.
Source: rss
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