The DOI matches its Crossref record; 28 of the 35 references it cites were found in a registry or an index.
Safety of GLP-1 Receptor Agonists and Other Second-Line Antidiabetics in Early Pregnancy
Open accessAbstract
Importance: Increasing use of second-line noninsulin antidiabetic medication (ADM) in pregnant individuals with type 2 diabetes (T2D) may result in fetal exposure, but their teratogenic risk is unknown. Objective: To evaluate periconceptional use of second-line noninsulin ADMs and whether it is associated with increased risk of major congenital malformations (MCMs) in the infant. Design, Setting, and Participants: This observational population-based cohort study used data from 4 Nordic countries (2009-2020), the US MarketScan Database (2012-2021), and the Israeli Maccabi Health Services database (2009-2020). Pregnant women with T2D were identified and their live-born infants were followed until up to 1 year after birth. Exposure: Periconceptional exposure was defined as 1 or more prescription fill of sulfonylureas, dipeptidyl peptidase 4 (DPP-4) inhibitors, glucagon-like peptide 1 (GLP-1) receptor agonists, and sodium-glucose cotransporter 2 (SGLT2) inhibitors, or insulin (active comparator) from 90 days before pregnancy to end of first trimester. Main Outcomes and Measures: Relative risks (RRs) and 95% CIs for MCMs were estimated using log-binomial regression models, adjusting for key confounders in each cohort and meta-analyzed. Results: Periconceptional exposure to second-line noninsulin ADMs differed between countries (32, 295, and 73 per 100 000 pregnancies in the Nordics, US, and Israel, respectively), and increased over the study period, especially in the US. The standardized prevalence of MCMs was 3.7% in all infants (n = 3 514 865), 5.3% in the infants born to women with T2D (n = 51 826), and among infants exposed to sulfonylureas was 9.7% (n = 1362); DPP-4 inhibitors, 6.1% (n = 687); GLP-1 receptor agonists, 8.3% (n = 938); SGLT2 inhibitors, 7.0% (n = 335); and insulin, 7.8% (n = 5078). Compared with insulin, adjusted RRs for MCMs were 1.18 (95% CI, 0.94-1.48), 0.83 (95% CI, 0.64-1.06), 0.95 (95% CI, 0.72-1.26), and 0.98 (95% CI, 0.65-1.46) for infants exposed to sulfonylureas, DPP-4 inhibitors, GLP-1 receptor agonists, and SGLT2 inhibitors, respectively. Conclusions and Relevance: Use of second-line noninsulin ADMs is rapidly increasing for treatment of T2D and other indications, resulting in an increasing number of exposed pregnancies. Although some estimates were imprecise, results did not indicate a large increased risk of MCMs above the risk conferred by maternal T2D requiring second-line treatment. Although reassuring, confirmation from other studies is needed, and continuous monitoring will provide more precise estimates as data accumulate.
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“These findings align with a recently published multinational population-based cohort study.”
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“Compared with insulin, there was no increased risk of major congenital malformations (adjusted relative risk 0.95, 95% CI, 0.72 to 1.26) for infants exposed to GLP1-RA.”
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“In a multinational population-based cohort study involving 51,826 pregnant women diagnosed with type 2 diabetes and their infants, the standardised prevalence of major congenital malformations was 8.3% among infants with periconceptional exposure to GLP1-RA (n=938).12”
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InfluentialPregnancy Outcomes After Semaglutide Exposure
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InfluentialGLP-1 receptor agonist therapy and pregnancy: Evolving and emerging evidence
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“12”
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“Cesta et al 46 conducted the largest study to date of GLP-1 RA – affected pregnancies with 51,826 pregnancies from three cohorts (Nordic countries, United States, and Israel) who had type 2 diabetes treated with antidiabetic medications.”
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GLP-1-Mediated Pregnancy and Neonatal Complications in Mice
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“35,36 Feghali et al. reported significant associations between the use of glyburide and metformin vs. insulin with caesarean delivery (OR 0.44; 95% CI 0.24–0.80) and excessive GWG (OR 0.44; 95% CI 0.24–0.80).”
InfluentialGLP-1 Receptor Agonist Exposure During Pregnancy
Kodali, L. S. M., Metlock, F., Nriagu, B. N., Brazile, T. L., Kwapong, Y. A., Dastmalchi, L. N., Spitz, J. A., & Sharma, G. V. (2026) · JACC Advances · doi:10.1016/j.jacadv.2026.102649 · Cited by 6
Abedi, M. M., Patni, M. M., Shajahan, A. N. B., Dube, R., Khadeeja, L., Alabid, I., Kharoufeh, A., Kar, S. S., George, B. T., Bahutair, S. N., et al. (2026) · Journal of Clinical Medicine · doi:10.3390/jcm15093204 · Cited by 6
“The global burden of obesity and type 2 diabetes mellitus has increased substantially over recent decades, affecting a growing proportion of women of reproductive age [1–3].”
Garg, S. K., Aktürk, H. K., Garg, S., Beck, R. W., Bellini, N. J., Bjornstad, P., Carlson, A. L., Carroll, J., Close, K., Block, C., et al. (2026) · Diabetes Technology & Therapeutics · doi:10.1177/15209156261449879 · Cited by 7
“138 – 140 By lowering mean glucose and BMI, as well as increasing TIR in individuals with T1D, GLP-1 and GLP-1/GIP RAs may reduce both obesity-and diabetes-related adverse pregnancy outcomes.”
Sharma, G. V. (2024) · Circulation · doi:10.1161/circulationaha.124.070766 · Cited by 6
The Potential Role of Glucagon-Like Peptide-1 (GLP-1) Agonists for Polycystic Ovary Syndrome
Rahim, S., & Pergolizzi, J. V. (2025) · Cureus · doi:10.7759/cureus.77998 · Cited by 6
“However, no direct link associated with major birth defects and GLP-1 RAs was established in the study [28].”
Insulin Allergy: The Allergist’s Updated Approach to Evaluation and Management
Oh, J., Vasquez, E. C., Arango, S. A., Ramesh, M., & Castells, M. (2025) · The Journal of Allergy and Clinical Immunology In Practice · doi:10.1016/j.jaip.2025.02.028 · Cited by 6
Diabetes Mellitus in Pregnancy: Implications for Obstetric Anesthesia
Rogers, W. K., Chugaieva, I., Moheet, A. A., & Wernimont, S. A. (2025) · Obstetric Anesthesia Digest · doi:10.1097/01.aoa.0001192196.21020.41 · Cited by 6
Lewin, Z., Snow, S., Lee, J. A., & Wilkie, G. (2025) · American Journal of Perinatology · doi:10.1055/a-2716-1639 · Cited by 5
“13 Similarly, Hanif et al conducted a retrospective cohort study with 3,652 patients with T2DM divided by GLP-1 RA exposure.”
Kuitunen, I. (2024) · Acta Paediatrica · doi:10.1111/apa.17412 · Cited by 5
Impact of Reducing Obesity in PCOS: Methods and Treatment Outcomes
Dzienny, A. C., & Seifer, D. B. (2025) · Journal of Personalized Medicine · doi:10.3390/jpm15110518 · Cited by 6
“Currently, there are not sufficient human studies to ensure its safety of use in early pregnancy [33], although retrospective data on pregnancies conceived along with inadvertent early exposure to GLP-1 therapy have been reassuring [33,105].”
Guo, Y., Souza, S. C. S., Bruce, L., Luo, R., El‐Chaâr, D., Gaudet, L., Muldoon, K. A., Hawken, S., Dunn, S., White, R. R., et al. (2024) · Obesity · doi:10.1002/oby.24143 · Cited by 5
Advances in postpartum hypertension management: a review of current guidelines and interventions
McCoy, S. E., Hurwitz, M., Kwapong, Y. A., Bircan, E., Spitz, J. A., Dastmalchi, L. N., Metlock, F., Saad, A. F., Sarma, A. A., Khandelwal, A., et al. (2025) · npj Women s Health · doi:10.1038/s44294-025-00095-7 · Cited by 9
“…data available investigating GLP1 receptor agonist exposure in early pregnancy showed no increased risk of pregnancy loss 61 or fetal malformation 62 , which is reassuring when considering possible inadvertent exposures, but signi fi cantly more research is needed on the subject 59,60 .”
Obesity, insulin resistance and fertility: unresolved questions and emerging insights
Narula, K., Kenkre, J. S., Loh, W. J., & Tan, T. (2025) · Current Opinion in Endocrinology Diabetes and Obesity · doi:10.1097/med.0000000000000907 · Cited by 5
Lee, I. O., Ghiasi, M., Wong, K. K. Y., & Walker, M. C. (2025) · Journal of Obstetrics and Gynaecology Canada · doi:10.1016/j.jogc.2025.103191 · Cited by 3
Crider, K. S., Adisa, O., Pfeiffer, C. M., Wang, A., Zhou, Y., Yeung, L. F., Bullard, K. M., Qi, Y. P., Rose, C. E., Fazili, Z., et al. (2026) · American Journal of Clinical Nutrition · doi:10.1016/j.ajcnut.2026.101193 · Cited by 3
Dilbaz, B., & Ateş, Ç. (2026) · The European Journal of Contraception & Reproductive Health Care · doi:10.1080/13625187.2026.2644895 · Cited by 3
Gestational diabetes: from pathogenesis to therapeutic intervention
Zhang, X., Chi, Y., Zhang, Z., Wang, Y., Yi, F., Wang, P., Liu, Y., & Hao, W. (2026) · Diabetology & Metabolic Syndrome · doi:10.1186/s13098-026-02156-6 · Cited by 3
Banerjee, M., Dutta, S., & Dasgupta, S. (2026) · Diabetes Obesity and Metabolism · doi:10.1111/dom.70853 · Cited by 4
“An exploratory safety analysis was also conducted in the secondary ‘abrupt discontinuation’ cohort with regard to MCM because of a probability of exposure to these agents during the peri-implantation period or early pregnancy, consistent with the exposure window used in previous studies [9, 10].”
Lemas, D. J., Zapata, R., Loy, I., Mahadevan, A. D., Wen, T. S.-T., Mkuu, R. S., Louis‐Jacques, A. F., Hall, J., Harrall, K. K., Strath, L. J., et al. (2026) · Obesity · doi:10.1002/oby.70221 · Cited by 3
“Population-level analyses from Denmark and Israel have reported preconception GLP-1RA exposure and selected perinatal outcomes [5, 10].”
InfluentialBrown, J. P., Huybrechts, K. F., Straub, L., Patorno, E., Seely, E. W., Bateman, B. T., & Hernández–Dı́az, S. (2026) · Annals of Internal Medicine · doi:10.7326/annals-25-04820 · Cited by 3
Self-citationNofal, A. A., Benkhadra, K., Abbas, A. S., Nduwimana, M.-J., Al-Kordi, M., Allababidi, A. K., Wyckoff, J., Lapolla, A., Prokop, L. J., Wang, Z., et al. (2025) · The Journal of Clinical Endocrinology & Metabolism · doi:10.1210/clinem/dgaf289 · Cited by 3
Su, C., He, X., Chang, X., Tian, J., Wang, G., & Liu, J. (2025) · Diabetes & Metabolism Journal · doi:10.4093/dmj.2024.0521 · Cited by 2
“The results of positive controls found that the genetically predicted drug effects were consistent with clinical evidence and mechanisms, indicating the robustness of the selected IVs [22,47,48].”
The Impact of GLP-1 Receptor Agonists on Women's Reproductive Health: A Review
Wolszczak, M., Wołodkiewicz, H., & Szmit, J. (2025) · Journal of Education Health and Sport · doi:10.12775/jehs.2025.82.60194 · Cited by 4
Exploring Challenges With Widespread Use of GLP-1–Based Therapies for Adolescents and Young Adults
Luo, J., Vajravelu, M. E., & Dusetzina, S. B. (2025) · Archives of Pediatrics and Adolescent Medicine · doi:10.1001/jamapediatrics.2025.2469 · Cited by 2
Fernandes, A., Gordon, A., & Sweeting, A. (2025) · Diabetes Obesity and Metabolism · doi:10.1111/dom.70116 · Cited by 3
“43 PCOS guidelines additionally suggest consideration of bariatric surgery.”
Burlina, S., Cioccoloni, D., Romanello, G., & Lombardi, S. (2025) · Acta Diabetologica · doi:10.1007/s00592-025-02601-4 · Cited by 2
Guiding Obstetric Care and Treatment Decisions for Women With Prior GLP-1 Receptor Agonist Use
Cesta, C. E., Hutcheon, J. A., & Johansson, K. (2025) · JAMA · doi:10.1001/jama.2025.19841 · Cited by 2
Self-citationJang, M., Kim, M., & Suh, H. S. (2026) · Nutrition Metabolism and Cardiovascular Diseases · doi:10.1016/j.numecd.2026.104572 · Cited by 3
Vardhan, S., Arnott, C. G., Chen, A., Frolova, A. I., Meka, R. A., Raghuraman, N., Vijay, A., Yoo, S. G., & Mahmoud, Z. (2026) · American Journal of Preventive Cardiology · doi:10.1016/j.ajpc.2026.101471 · Cited by 2
“Another population-based cohort study followed over 900 women with pre-gestational T2DM and exposure to GLP-1 agonists in the first trimester, and found no increased risk of congenital malformations compared to those using insulin or other antidiabetic medications [73].”
GLP-1 Receptor Agonist Use Across Preconception, Pregnancy, and the Postpartum Periods
Porterfield, F., Ogunwole, S. M., Maya, J., & Stanford, F. C. (2026) · Pediatric Drugs · doi:10.1007/s40272-026-00746-5 · Cited by 2
Wu, Y.-C., Hsu, J. C., Su, E. C., Chen, C., & Chang, T. (2026) · Reproductive Biology and Endocrinology · doi:10.1186/s12958-026-01549-6 · Cited by 2
“For instance, a recent multinational cohort study involving over 50,000 pregnancies found no substantial increase in major congenital malformations following first-trimester exposure to GLP-1 receptor agonists [17].”
InfluentialAndrade, C. (2024) · The Journal of Clinical Psychiatry · doi:10.4088/jcp.24f15318 · Cited by 2
Varughese, M. S., & Jacob, S. (2025) · Clinical and Experimental Ophthalmology · doi:10.1111/ceo.14529 · Cited by 2
Promising Safety Profile of Noninsulin Medications for Type 2 Diabetes in Early Pregnancy
Ghaffari, N. (2024) · JAMA Internal Medicine · doi:10.1001/jamainternmed.2023.8422 · Cited by 2
Teratogenic risks of treated and untreated maternal obesity
Jones, R. E., & Zera, C. (2025) · Seminars in Perinatology · doi:10.1016/j.semperi.2025.152081 · Cited by 1
GLP-1 Receptor Agonist Use in Pregnancy
Druce, I. (2025) · Canadian Diabetes & Endocrinology Today · doi:10.58931/cdet.2025.3139 · Cited by 1
Kettner, J. T., Donnelly, E. T., & Maes, M. L. (2025) · Journal of Pharmacy Practice · doi:10.1177/08971900251376795 · Cited by 2
“62 The adjusted relative risk of major congenital malformation was 0.95 (95% con fi dence interval 0.72 to 1.26) for infants exposed to GLP1RAs in the periconceptional period (90 days before pregnancy to end of fi rst trimester) compared with insulin.”
InfluentialZhou, L., Duanmu, W., Tan, F., Gu, X., Che, H., & Yin, W. (2025) · BMC Health Services Research · doi:10.1186/s12913-025-13377-2 · Cited by 2
“GLP-1RA is a new type of hypoglycemic drug used in the treatment of T2DM, which is widely used in clinical practice at home and abroad due to its reliable and safe efficacy [23–25].”
Metadata
- Authors
- Cesta, C. E., Rotem, R., Bateman, B. T., Chodick, G., Cohen, J. M., Furu, K., Gissler, M., Huybrechts, K. F., Kjerpeseth, L. J., Leinonen, M. K., Pazzagli, L., Zoega, H., Seely, E. W., Patorno, E., & Hernández-Díaz, S.
- Affiliations
- Karolinska Institutet (SE)
- Harvard University (US)
- Stanford Medicine (US)
- Maccabi Healthcare Services (IL)
- Norwegian Institute of Public Health (NO)
- University of Turku (FI)
- Brigham and Women's Hospital (US)
- Finnish Institute for Health and Welfare (FI)
- School of Population Health, Faculty of Medicine & Health, UNSW Sydney, Sydney, New South Wales, Australia
- Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, Massachusetts
- Corresponding author
- Cesta, Carolyn E.
- ORCID
- Venue
- JAMA Internal Medicine
- Publisher
- American Medical Association (AMA)
- Published
- 2024-02-01
- Volume
- 184
- Issue
- 2
- Pages
- 144
- ISSN
- 2168-6106 (ISSN-L)
- PMC
- PMC10714281
- OpenAlex
- W4389553854
- Cited by
- 200
- References
- 35
- Citations by year
- 2026: 90 · 2025: 79 · 2024: 31
- FWCI
- 51.20
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- cc-by
- Locations
- JAMA Internal Medicine (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Opin vísindi (Opin vísindi) (submittedVersion, cc-by-nc-sa)
- Opin vísindi (Opin vísindi) (submittedVersion, other-oa)
- STM:n Hallinnonalan avoin julkaisuarkisto (Julkari) (submittedVersion)
- Funders
- European Commission (844728)
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (R01HD097778)
- Topics
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Pregnancy and Medication Impact
- Health Sciences › Medicine › Obstetrics and Gynecology › Gestational Diabetes Research and Management
- Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmacological Effects and Toxicity Studies
- Keywords
- GLP-1 receptor agonists, type 2 diabetes in pregnancy, major congenital malformations, teratogenicity, sulfonylureas, DPP-4 inhibitors, SGLT2 inhibitors, insulin, prenatal exposure, pregnancy safety, liveborn infants, first trimester
- MeSH terms
- Glucagon-Like Peptide-1 Receptor, Sodium-Glucose Transporter 2 Inhibitors, Glucagon-Like Peptide-1 Receptor Agonists, Diabetes Mellitus, Type 2, Female, Humans, Hypoglycemic Agents, Insulin, Pregnancy, Sulfonylurea Compounds, Cohort Studies, Dipeptidyl-Peptidase IV Inhibitors
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