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Two reviews found no clear increase in most measured adverse outcomes when GLP-1 drugs were used around conception or stopped during early pregnancy. The studies do not establish that the drugs are safe during pregnancy, and researchers say current advice to stop before planned conception remains in place.
Two reviews of pregnancy data found no clear increase in most measured adverse outcomes among women exposed to GLP-1 receptor agonists around conception or in early pregnancy, according to research reported at the European Association for the Study of Diabetes meeting. The authors said the findings do not establish the drugs’ safety during pregnancy and that advice to stop treatment before planned conception should 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 size among women who used GLP-1 drugs in the period around conception. The analysis also found no clear increase in excess gestational weight gain.
The pooled estimate for preeclampsia was lower among exposed women, with an odds ratio of 0.87 and a 95% confidence interval of 0.78 to 0.98. But 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; the analysis does not show that the drugs prevent preeclampsia.
A second review, presented at the meeting and published in Lancet Obstetrics, Gynaecology, & Women’s Health, included data on more than 40,000 women, primarily with type 2 diabetes. Across four studies, it found no increase in congenital anomalies when GLP-1 drugs were discontinued during the first trimester. Early pregnancy loss was more common in exposed women in two studies, but interpretation was difficult because the largest study combined miscarriage and termination in its measure.
Pregnancy Evidence Remains Limited
The reviews examined pregnancy outcomes among people exposed to GLP-1 medicines before or during early pregnancy. The first review’s authors said the results may offer limited reassurance after inadvertent exposure before conception or in early pregnancy. They did not recommend continuing treatment during pregnancy.
Both reviews draw on existing studies, which cannot resolve every safety question. The evidence varied in how it defined exposure, and the researchers identified possible residual confounding and small numbers of studies for several outcomes. The results therefore do not rule out risks that the available data could not detect.
Current Advice Before Conception
GLP-1 receptor agonists are not approved for use during pregnancy. Drug labeling recommends stopping them at least two months before planned conception, although that guidance itself is based on limited human data. The first review’s authors said their results do not support changing that recommendation.
The second review’s team developed an international consensus statement on GLP-1 use before, during and after pregnancy in women with diabetes. Claire Meek of the University of Leicester said the guidance sets out clinical targets for preconception use and ways to help women understand when and how to stop treatment. She also said contraception is strongly recommended while taking the drugs, and treatment should stop if pregnancy occurs.
“The findings “may provide limited reassurance following inadvertent exposure before conception or during early pregnancy,” but should not be interpreted as supporting continued treatment during pregnancy.”
— Asma Khalil and colleagues
Safety Questions Still Open
The reviews cannot establish whether GLP-1 drugs are safe during pregnancy. The first analysis had differences in how studies defined exposure and possible residual confounding; several outcomes were informed by few studies. In the second review, the higher rate of early pregnancy loss is hard to interpret because miscarriage and termination were combined in the largest contributing study.
Evidence is also scarce on use in type 1 diabetes, gestational diabetes and during breastfeeding. The consensus authors said direct evidence on GLP-1 drugs in gestational diabetes is lacking, and data during lactation remain limited. The available studies do not settle whether use before conception or after birth improves outcomes for these groups.
More Research and Guidance Needed
The consensus statement offers prescribing guidance for use before, during and after pregnancy in women with diabetes, but the study authors said more evidence is needed before recommendations can be reconsidered. Meek said the guidance proposes ways to monitor people using the drugs before conception and to support safe discontinuation.
The researchers 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. Until stronger evidence is available, the first review’s authors said current recommendations to stop GLP-1 receptor agonists before planned conception should remain in place.
Key Questions
Did the reviews find that GLP-1 drugs are safe during pregnancy?
No. The reviews found no clear increase in most measured outcomes, but their authors said the evidence is limited and does not establish safety during pregnancy.
What should someone do if they become pregnant while taking a GLP-1 drug?
Claire Meek said treatment should stop in early pregnancy if conception occurs. People should contact their prescribing clinician for advice about their individual treatment; the studies do not provide personal medical guidance.
What do current recommendations say about planned pregnancy?
Drug labeling recommends stopping GLP-1 receptor agonists at least two months before planned conception. The review authors said the new findings do not support changing that advice.
Why was early pregnancy loss reported as more common in one review?
The second review found a higher rate in exposed women across two studies, but the result is difficult to interpret because miscarriage and termination were combined in the largest contributing study.
Source: rss
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