Although semaglutide is generally considered to be safe, it is not recommended for women who are pregnant or trying to become pregnant.

Sometimes, women prescribed semaglutide may become pregnant while on the medication, and this can be cause for concern. Although semaglutide is generally considered to be safe, it is not recommended for women who are pregnant or trying to conceive. There may be other instances where women are trying to lose weight or control their blood sugar, and ask if semaglutide and pregnancy are a safe combination. Patients may also express questions or concerns about semaglutide and birth defects or semaglutide and breastfeeding.

Semaglutide and Pregnancy

A National Library of Medicine fact sheet published in March 2023¹ notes that human research has not been conducted to assess semaglutide’s association with preterm delivery (birth before 37 weeks) or low birth weight (< 5lbs. 8 oz.). Because there is little data on semaglutide’s safety and human pregnancy outcomes, its manufacturer clearly articulates and advises that women stop taking semaglutide at least two months prior to trying to conceive.² However, a 2024 multicenter study³ assessed the risks associated with semaglutide in early pregnancy and found that exposure to a GLP-1 RA was not associated with a risk of major birth defects compared to being a woman with diabetes, or a woman with obesity; despite this, semaglutide and pregnancy are still not advised.

 

A multicenter, prospective, observational cohort study, which included members of the European Network of Tetralogy Information Services (ENTIS), was conducted to investigate the effects of semaglutide during pregnancy. ENTIS specializes in potential risks associated with exposure to medications during pregnancy and while breastfeeding.^2,4 Health care professionals and pregnant women can contact ENTIS for an assessment. Data is collected during the initial contact and again following the expected delivery date. ENTIS collects information relating to the drug exposure, drug treatment indication, dosage, timing of initiation, duration, and concurrent medications. Post-delivery, additional information such as further medication use, pregnancy outcomes, gestational age at delivery, birth weight, birth defects, and neonatal complications was collected. For this 2024 multicenter study, information relating to diabetes and obesity status were also collected.

 

Participants included women exposed to a GLP-1 RA (168 women), as well as two reference groups: women with diabetes (156 women) and women with obesity (163 women). Semaglutide was the second most prescribed GLP-1 RA in the exposed group (n = 51). For all participants in the study, ENTIS was contacted between 2009-2022. Only patients with unknown pregnancy outcomes were included in the study.

 

The first reference group was women with diabetes taking, in most instances, metformin. The second reference group was pregnant women with overweight (BMI ≥ 25 kg/m²) or obesity (BMI ≥ 30 kg/m²). Reference groups were randomized and matched for timeframe and BMI for the exposed group. Exclusion criteria included exposure to medications such as systemic retinoids, cytoxic agents and antiepileptic drugs, thalidomide, leflunomide, lenalidomide, and coumarin derivatives. Assessment of birth defects were restricted to live births and pregnancy losses with confirmed outcomes. Minor birth defects were not included because of suspected possible under reporting. Other outcomes included abortion and stillbirths. Preterm birth was a secondary outcome.

 

Results suggest there was no pattern of birth defects observed in the GLP-1 RA exposed group. The authors note that additional research following an inadvertent exposure to a GLP-1 RA is needed.

Semaglutide and Breastfeeding

There are limited data on postpartum mothers and breastfeeding while taking a GLP-1 medication, though early evidence suggests that semaglutide concentrations in human milk may not pose a clinical concern for breastfeeding mothers. Currently, the FDA is not approving the use of GLP-1 RAs without lactation data, so it is important to understand the risks of taking semaglutide while breastfeeding.⁵

 

Data from the InfantRisk Human Milk Biorepository (HMB) were used to assess the safety of semaglutide during breastfeeding. Lactating women expressed milk at 0, 12, and 24 hours post administration of subcutaneous semaglutide. Infants did not consume breast milk as part of this study. Semaglutide was extracted from the breast milk using protein precipitation in methanol followed by chromatographic separation. Linear calibration curves for methanol ranged from 2.5 – 3.0 ng/mL. Undetectable concentrations of semaglutide were found in breast milk at LLOQ 5.7 ng/mL and LLOD of 1.7 ng/mL. The LLOQ as the drug concentration in milk relative to semaglutide’s bioavailability and long-term dose profile was used to calculate a worst-case scenario for the relative infant dose (RID). Results suggest the maximum RID was estimated to be 1.26 percent, which is below the 10 precent safety threshold. Results do suggest semaglutide concentrations in human milk are not likely to pose a clinical concern for infants who are breast fed. The authors do note that health care providers should monitor current information to help make informed decisions relating to postpartum therapeutic interventions.

Practical Implications for Health Care Providers

Semaglutide and pregnancy are not recommended. Although there is a paucity of human research studies that focus on semaglutide and birth defects, it is recommended that women who are trying to get pregnant stop taking semaglutide at least two months before trying to conceive. In the event of inadvertent GLP-1 RA intake while pregnant, results suggest that there were no observed patterns of semaglutide and birth defects. Additionally, concentrations of semaglutide in breast milk were not observed to be a clinical concern, though monitoring for the most up-to-date information is warranted.

 

Health care providers who are working with women who wish to conceive should discuss dietary and physical activity lifestyle changes to manage weight loss. GLP-1 RAs are but one strategy for weight loss. Dietary changes such as building sustainable, long-term healthy eating habits should be explored, and the Dietary Guidelines for Americans offer a framework for shaping the conversation and offering empirically-based guidance.

 

While GLP-1 RA medications are generally safe, they should be avoided while pregnant or trying to become pregnant.

 

Nonpharmacological Weight Management Solutions

For patients who are unable or not suited to use GLP-1 receptor agonists for weight loss, nonpharmacological interventions play a critical role in comprehensive obesity treatment. Robard Corporation’s Low Calorie Diet (LCD) and Very Low Calorie Diet (VLCD) programs offer a clinically supported, medication-free alternative that helps practitioners effectively manage weight in this patient population.

 

Programs such as New Direction Advanced and Numetra provide structured, science-based nutritional plans that include scientifically designed meal replacements, patient education, and clinical protocols. These solutions not only help meet essential nutritional needs but also promote long-term behavior change and sustainable weight loss. By integrating Robard’s programs into treatment pathways, health care providers can offer a proactive and proven option for patients seeking or requiring a nonpharmacologic route to healthier weight and improved outcomes.

 

Source(s):

1 National Library of Medicine: Mother to Baby Fact Sheets: Semaglutide

2 Use of GLP1 receptor agonists in early pregnancy and reproductive safety: a multicentre, observational, prospective cohort study based on the databases of six Teratology Information Services

3 EMA . Ozempic: EPAR – product information
4 Pregnancy outcome following maternal exposure to Mirtazapine: a multicenter, prospective study

5 Subcutaneous semaglutide during breastfeeding: infant safety regarding drug transfer into human milk

6 Dietary Guidelines for Americans

 

About the Author: Dr. Dawn M. Sweet has over 20 years of experience in the field of communication. Dr. Sweet has given several invited talks to and workshops for academic and private sector audiences on the role of nonverbal and verbal communication in achieving positive outcomes and mitigating bias. Her research has been published in several top ranked peer-review journals, and it has been featured on NPR’s River to River / All Things Considered, Buzzfeed, and Science Daily. Her research has also been used to inform expert testimony.

About Robard: Robard Corporation’s medical obesity treatment programs and scientifically-designed nutrition products have been utilized by physicians, surgeons and hospitals across the United States to successfully treat patients living with obesity. To learn more about us and how we can help your practice and patients, visit us online www.Robard.com, email us at info@robard.com, or call (800) 222-9201.