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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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“GLP-1RA use is frequent and increasing in women with type 2 diabetes of fertile age [ 11 – 13 , In the available literature [29 , 37–39 ] on potential tera - togenic effects of GLP-1RA exposure in pregnant women with type2 diabetes, congenital malformations have been classified using different…”
InfluentialGlucagon-Like Peptide-1 Receptor Agonists and Risk of Adverse Maternal Pregnancy Outcomes
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Che cosa non sappiamo sugli SGLT-2 inibitori
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Indeed, safety comes first for the use of GLP ‐1RAs
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One Step Closer to Unlocking Preeclampsia Prevention
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Schwangerschaft und Diabetes – ein Update
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Recent Advances in Benzoheterocycle Heterocyclic Compounds as α-Glucosidase Inhibitors
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Perspectives of Obstetricians and Gynaecologists on the Use of Weight Loss Medications
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Diabetes mellitus and pregnancy
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Weighing up the options: childhood intervention to tackle obesity
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Outcomes of pregnancies complicated by type 2 diabetes
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Self-citationCurrent Use of Common Data Models in the Nordic Countries
Ompad, G. D., Cesta, C. E., Cohen, J. M., Leinonen, M. K., Taipale, H. T., Li, H., Gudmundsson, L. S., Gissler, M., & Sessa, M. (2025) · Pharmacoepidemiology and Drug Safety · doi:10.1002/pds.70242
Self-citationGlucagon-like Peptide-1 Receptor Agonist Use in Pregnancy: a Review
Drummond, R., Seif, K., & Reece, E. A. (2025) · Obstetric Anesthesia Digest · doi:10.1097/01.aoa.0001170996.74529.26
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Weight Management Through a Woman’s Life Stages: A Practical Evidence-Based Guide
Scholcoff, C., Yecies, E. B., Worthington, R. O., & Farkas, A. H. (2025) · Journal of Women s Health · doi:10.1177/15409996251405062
“56 Due to the long half-life of the medications (tirzepatide 5 days, semaglutide 7 days) and the increased accumulation with higher doses and duration of medication use, discontinuation of weekly GLP-1 RAs or GIP/GLP-1 RAs one to two months prior to conception is best practice.”
Hashmani, F. N., Black, K. I., Sweeting, A., Hall, K. A., Ilomaki, J., & Grzeskowiak, L. E. (2026) · Pharmacoepidemiology and Drug Safety · doi:10.1002/pds.70320
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Invited commentary: Advancing the management of type 2 diabetes in pregnancy
Carrieri, F., Scott, E. M., & Murphy, H. R. (2026) · Diabetic Medicine · doi:10.1111/dme.70219
“12,13 However, these therapies are typically discontinued around conception due to lack of data regarding the risks and benefits of ongoing use.”
Kuoni, S., Dolder, A., Lehmann, R., Steiner, R., Ochsenbein-Kölble, N., & Simões‐Wüst, A. P. (2026) · Biomedicine & Pharmacotherapy · doi:10.1016/j.biopha.2026.119097
GLP-1 RA Eligibility in Reproductive-Age U.S. Women
Shi, I., Khan, S. S., Grobman, W. A., & Kazi, D. S. (2026) · Diabetes Obesity and Cardiometabolic CARE · doi:10.2337/doc25-0040
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Systematic Reviews to Inform Practice, March/April 2026
Harris, N. R., Howe‐Heyman, A., & McManis, B. G. (2026) · Journal of Midwifery & Women s Health · doi:10.1111/jmwh.70111
Zhu, Y., & Hedderson, M. M. (2026) · Human Reproduction Open · doi:10.1093/hropen/hoag016
“Multinational registry and claims analyses spanning four Nordic countries, the USA, and Israel have not shown a higher risk of major congenital malformations with periconceptional GLP-1 RA exposure compared with insulin among pregnancies affected by type 2 diabetes (Cesta et al. , 2024).”
Type 2 Diabetes in Pregnancy: Management and Novel Therapies
Wilkie, G. (2026) · Clinical Obstetrics & Gynecology · doi:10.1097/grf.0000000000001008
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Weight management in women of reproductive age
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Targeting metabolism to protect fertility and healthy pregnancy with SGLT2 inhibitors and GLP-1RAs
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Pregnancy After Bariatric Surgery: Understanding and Managing Postprandial (Reactive) Hypoglycemia
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Wallentowitz, L., García, M. G., Atorrasagasti, C., Harms, C., Huhn, E. A., Roser, P., Verlohren, S., Giesen, E. M., & Blois, S. M. (2026) · Reviews in Endocrine and Metabolic Disorders · doi:10.1007/s11154-026-10053-6 · Cited by 3
Management der Hyperglykämie in der Schwangerschaft (Update 2026)
Kautzky‐Willer, A., Winhofer, Y., Leutner, M., Kiss, H., Falcone, V., Linder, T., Berger, A., Wisgrill, L., Lechleitner, M., Weitgasser, R., et al. (2026) · Wiener klinische Wochenschrift · doi:10.1007/s00508-025-02695-4
“Präliminäre Anwendungsdaten zu Schwangerschafts-beginn zeigen aber keinen Hinweis auf ein erhöh-tes Risiko für Fehlbildungen [31]; Andererseits war eine Therapie mit GLP-1-Rezeptoragonisten inner-halb von 24 Monaten vor einer Schwangerschaft mit besseren Schwangerschafts-Outcomes und weniger…”
Rajamoorthi, A., Hollingsworth, T., Guan, Y., Pinney, S. E., & Simmons, R. A. (2026) · bioRxiv (Cold Spring Harbor Laboratory) · doi:10.64898/2026.06.07.730723
“…(HAPO) study and subsequent follow-up studies which examined child outcomes at 10-14 years of age, have shown that subclinical metabolic dysfunction in pregnant women during the second trimester, characterized by elevated plasma glucose not diagnostic of gestational diabetes at that time, are…”
Sun, H., Gu, F., 吴立培, Chen, X., & Xuan, S. (2026) · Frontiers in Immunology · doi:10.3389/fimmu.2026.1856187
Dziewierz, A., Kulicka, N., Stolarska, K., Ahmatovic, A., Domienik‐Karłowicz, J., Rulkiewicz, A., & Siudak, Z. (2026) · Diabetes Obesity and Metabolism · doi:10.1111/dom.71017 · Cited by 1
“Recent large cohort studies have not consistently shown an increased risk of major congenital malformations after peri-conceptional GLP-1 RA exposure, but data remain limited and particularly sparse for continued use during pregnancy and lactation [26, 27].”
Vlasak, A., Lindsey, P., Minnihan, A., & Rhoton-Vlasak, A. (2026) · Reproductive Sciences · doi:10.1007/s43032-026-02136-1
“…GLP-1 receptor agonsists exposure compared to other anti - diabetic agents or unexposed controls, while observational data adjusted for obesity and diabetes show no significant association with pregnancy complications including pre-eclampsia, gestational diabetes, or preterm birth [6, 9, 32 ].”
Role of insulin in female reproduction
Tebeau, K. S., & Polotsky, A. J. (2026) · Current Opinion in Obstetrics & Gynecology · doi:10.1097/gco.0000000000001121
Wong, K., Al-Amri, H., & Werlang, A. (2026) · Case Reports in Women s Health · doi:10.1016/j.crwh.2026.e00831
Xu, W., Lu, C., Xu, J., & Wang, L. (2026) · Neuroscience & Biobehavioral Reviews · doi:10.1016/j.neubiorev.2026.106846
Bai, M., Shen, Q., Wu, Y., Chen, M. L., Liu, D., Lin, N., & Zhang, W. (2026) · BMC Pregnancy and Childbirth · doi:10.1186/s12884-026-09515-1
“Furthermore, a recent extensive multicenter observational cohort study found no increase in major congenital malformations in newborns exposed to DPP-4 inhibitors during early pregnancy compared to those exposed to insulin [48].”
Drummond, R. F., Seif, K. E., & Reece, E. A. (2026) · American Journal of Obstetrics and Gynecology · doi:10.1016/j.ajog.2026.07.009
Kotanidou, S., Dampali, R., Devaja, O., Montalto, S. A., Godfrey, M., Papadopoulos, A., Daniilidis, A., Nikolettos, N., & Nikolettos, K. (2026) · Reproductive Medicine · doi:10.3390/reprodmed7030034
Agoniste du GLP-1 durant la grossesse. Quels risques ? Des données encore incomplètes
Halimi, S. (2026) · Médecine des Maladies Métaboliques · doi:10.1016/j.mmm.2026.06.014
Lapolla, A., & Torlone, E. (2026) · Expert Review of Endocrinology & Metabolism · doi:10.1080/17446651.2026.2707565
“Despite a number of evidence-based guidelines recommending insulin as the preferred anti-diabetic medication in pregnancy [19], the frequency of metformin use in pregnancies complicated by T2D has been steadily increasing [55].”
InfluentialMalbert, C., Delarue, J., & Guéant, J. (2026) · Bulletin de l Académie Nationale de Médecine · doi:10.1016/j.banm.2026.07.004
Zajdenverg, L., Santos, V. M., Rodrigues, A. C. M., Previdelli, L. K., & Negrato, C. A. (2026) · Diabetology & Metabolic Syndrome · doi:10.1186/s13098-026-02235-8
“The use of GLP-1RAs was not associated with a significant increase in the risk of major congenital malformations, compared with insulin, the gold standard for DM treatment during pregnancy [30].”
Vanlaer, Y., de Cauter, E. V., Embo, N., & Benhalima, K. (2026) · BMC Medicine · doi:10.1186/s12916-026-05182-3
“In animal models, exposure during gestation has been linked to reduced fetal growth and decreased fetal weight, as well as delayed or abnormal ossification, skeletal variants such as wavy ribs, and visceral abnormalities [29–31].”
InfluentialTrends in GLP ‐1‐Based Therapy Use Before and After Pregnancy
Boghossian, N. S., McAbee, L., Saad, A. F., Costantine, M. M., Ma’ayeh, M., & Ewing, J. A. (2026) · Diabetes Obesity and Metabolism · doi:10.1111/dom.71301
“Although recent studies have not demonstrated a clear increase in major congenital malformations following early pregnancy exposure [5, 6], evidence remains limited [7].”
GLP-1 Receptor Agonists and Reproductive Health
Porterfield, F., Mulligan, J., Salim, K., Olubowale, O. O., & Stanford, F. C. (2026) · Endocrinology and Metabolism Clinics of North America · doi:10.1016/j.ecl.2026.07.003
Jastreboff, A. M., Ard, J. D., Hall, K. D., Kaplan, L. M., Krumholz, H. M., Name, M. A. V., Ryan, D. H., & Drucker, D. J. (2026) · Endocrine Reviews · doi:10.1210/endrev/bnag025
“The available evidence from registry and real-world databases does not reveal an increased risk of major malformations for women with T2D or obesity exposed to GLP-1 RA medicines in the first trimester (222, 223).”
The peptide blind spot in donor screening
Parisi, N., Zeybek, A., & Akgün, Y. (2026) · Transfusion · doi:10.1111/trf.70391
Eddy, E., Long, B., Sandei, T., & Meyer, M. (2026) · Elsevier eBooks · doi:10.1016/b978-0-443-44037-3.00651-5
de Matos, S. M. S., Faccini, L. S., Vianna, F. S. L., & Fraga, L. R. (2026) · Frontiers in Endocrinology · doi:10.3389/fendo.2026.1911235
“When evaluating risk for malformations, the review found no signi fi cant increase in the risk of major congenital malformations with semaglutide use in pregnancy compared with insulin exposure (34, 37).”
Eddy, E., Long, B., Sandei, T., & Meyer, M. (2026) · Elsevier eBooks · doi:10.1016/b978-0-443-44037-3.00649-7
Long, B., Eddy, E., Sandei, T., & Meyer, M. (2026) · Elsevier eBooks · doi:10.1016/b978-0-443-44037-3.00652-7
Hidradenitis Suppurativa from Preconception to Lactation: Clinical Treatment Decision-Making Review
Lewandowski, M., Szablewska, W., Sławińska, M., Kujach, A., Nowicki, R. J., & Barańska‐Rybak, W. (2026) · Dermatology and Therapy · doi:10.1007/s13555-026-01909-5
“…exposure to GLP‑1RAs for diabetes did not result in a large increased risk of major congenital malformations compared with insulin, clinicians are still urged to exercise caution and adhere to conservative prescribing guidelines until more definitive human evidence is established [108].”
Collier, M., Chouchana, L., Kaguelidou, F., Tréluyer, J., & Bérard, A. (2026) · Diabetologia · doi:10.1007/s00125-026-06882-4
D’Antonio, F., Flacco, M. E., Manzoli, L., SAMARA, A. A., & Khalil, A. A. (2026) · Med · doi:10.1016/j.medj.2026.101267
Zica, L. P., & Ramos, T. C. M. D. S. (2026) · Revista Contemporânea · doi:10.56083/rcv6n10-003
Peymani, P., Aboulatta, L., Khan, M. W., Drăgan, R., & Eltonsy, S. (2026) · Obesity Research & Clinical Practice · doi:10.1016/j.orcp.2026.10.001
Diretriz Brasileira de Insuficiência Cardíaca – 2026
Simões, M. V., Moura, L. Z., Martins, S. M., Mourilhe‐Rocha, R., Danzmann, L. C., Neto, J. A. D. F., Marcondes‐Braga, F. G., de Oliveira, M. T., de Albuquerque, D. C., Freitas, A. F., et al. (2026) · Arquivos Brasileiros de Cardiologia · doi:10.36660/abc.20260830
Groten, T. (2026) · Deutsches Ärzteblatt · doi:10.3238/persgyn.2026.10.16.01
Long, B., Eddy, E., Sandei, T., & Meyer, M. (2026) · Elsevier eBooks · doi:10.1016/b978-0-443-44037-3.00650-3
Kar, E., Yeh, J., Efe, M. A., Çelik, H. G., Bozdağ, G., & Baştu, E. (2026) · European Journal of Obstetrics & Gynecology and Reproductive Biology · doi:10.1016/j.ejogrb.2026.115499
Haynie, C., Musty, A., Choi, H., Lewis, K. H., Stamilio, D. M., Jensen, E. T., & Ahmed, A. M. (2026) · European Journal of Obstetrics & Gynecology and Reproductive Biology · doi:10.1016/j.ejogrb.2026.115503
Mavigök, E., & Mavigök, A. N. (2026) · Frontiers in Pharmacology · doi:10.3389/fphar.2026.1994366
“Cesta reported adjusted RR 0.95 versus insulin and crude OR 1.02 (Cesta et al., 2024).”
InfluentialOral hypoglycemic medications for GDM treatment
Lindsay, R. S., & Mackin, S. T. (2026) · Elsevier eBooks · doi:10.1016/b978-0-443-13265-0.00019-7
Dutta, D., Mahajan, K., Gupta, G., Sharma, M., Sugandha, S., & Kamrul-Hasan, A. B. M. (2026) · Endocrine · doi:10.1007/s12020-026-04839-6
Safe prescribing in pregnancy: Medication considerations for people with spinal cord injury
Rea, S., Wood, W. J., Shi, E., Clay, S., Iliescu, D., Menendez, K., & Ryder, S. C. (2026) · Journal of Spinal Cord Medicine · doi:10.1080/10790268.2026.2751310
Living Liver Donors With Obesity and Metabolic Risk: Review and Guidance on Donor Triage and Care
한효선, Chacko, K. R., Orandi, B., Ahrens, D. V., Shingina, A., Kim, S. C., Watt, K. D. S., & Liapakis, A. (2026) · Clinical Transplantation · doi:10.1111/ctr.70681
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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