Study Finds Similar Rates of Pregnancy in Women Who Were and Were Not Prescribed GLP-1 Medications

Glucagon-like peptide-1 (GLP-1) receptor agonists, such as semaglutide (Ozempic, Weygovy; Novo Nordisk) and dulaglutide (Trulicity; Eli Lilly and Co) have become increasingly recognized for their role in diabetes care, as well as use for rapid weight loss. Both medications were approved by the FDA in 2023 for its effects on diabetes in addition to established cardiovascular benefits and emerging evidence for protective renal effects.¹

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In addition to these effects, another factor of the medication is its ability to slow gastric emptying, which is an alleged contributor to unplanned pregnancies. Novo Nordisk did not specifically state whether this would impact the efficacy of contraceptives, rather that this effect may influence the absorption of “concomitantly administered oral medicinal products.”¹ The company has also reported that there was no observed clinically significant drug-drug interaction between semaglutide and ethinylestradiol or levonorgestrel.¹

Despite this, there have been reports from women who became unexpectedly pregnant while taking or soon after starting GLP-1 medications.¹ With this information, investigators with Epic Research evaluated 27,054 women aged 18 to 50 years who were prescribed a GLP-1 medication to determine the occurrence of pregnancy. The women were matched by age, body mass index (BMI), conditions affecting fertility, and history of diabetes with 180,866 women who were not prescribed a GLP-1 medication. The GLP-1 medications prescribed included semaglutide, dulaglutide, liraglutide (Victoza; Novo Nordisk), and tirzepitide (Mounjaro, Zepbound; Eli Lilly and Co).²

The study findings demonstrated that the rates of pregnancy in the year following treatment with a GLP-1 medication were similar to those who were not prescribed a medication. The pregnancy rate for women who were not prescribed a GLP-1 medication was approximately 3.86%, and the rates for women who were prescribed a GLP-1 were about 3.42% (semaglutide), 3.98% (liraglutide), 3.86% (dulaglutide), and 3.48% (tirzepitide). Further, pregnancy rates were also observed to be similar across GLP-1 medications, with semaglutide presenting the lowest rate (3.42%) and liraglutide the highest (3.98%).²

These findings² differ from other research, with a review on the treatment of obesity and fertility that consisted of 5 randomized controlled trials showing that weight loss interventions with an average of 7% loss (9 to 20 pounds) had resulted in higher rates of spontaneous conception. These findings, however, were contradicted when a metanalysis found that significant weight loss did not improve clinical pregnancy or live birth rates. These increased unplanned pregnancies with concurrent use of semaglutide in women may be indirectly associated to the drug’s weight loss abilities, rather than a direct effect on fertility itself.¹

There are also unknowns about how GLP-1s may affect pregnancy and/or neonatal outcomes.^1,3 Another Epic Research study assessed 775,478 pregnancies in women without a history of diabetes and who did not develop gestational diabetes and found that babies who were born to mothers prescribed a GLP-1 agonist medication (eg, semaglutide or tirzepatide) were at an increased risk of neonatal intensive care unit stays. Additionally, babies born to mothers who were not prescribed GLP-1 medications and women who were prescribed these medications 90 days prior or during the first trimester had similar rates of failure to thrive or congenital heart defect diagnoses.³

Further, these findings also indicated that although the rates of pre-term deliveries increased for women in the 2 surveyed weight loss medication groups, after controlling for other risk factors (eg, maternal age and BMI), the rates of pre-term delivery were similar for mothers prescribed weight loss medications compared with those who were not. In addition, exposure to weight loss medications during the first trimester presented similar results to exposure in the 90 days prior to pregnancy.³

Alternatively, another study found that in 168 pregnant women who were exposed to GLP-1 receptor agonists during their first trimester, there was no significant increased risk of pregnancy loss when compared with diabetes and overweight/obese reference groups. These results were observed when compared birth defects, and these investigators urged that more research is conducted to better understand the safety of semaglutide during pregnancy.¹

Overall, GLP-1 medications are generally avoided in pregnancy because of the limited data on safe use within this population. Novo Nordisk’s prescribing information recommends that a patient should discontinue semaglutide use for 8 weeks before planning to become pregnant, and patients should contact their health care professional for alternative methods of managing blood sugar.¹ Further, it is also important to consider that weight loss experienced from semaglutide may also impact spontaneous conception. It is recommended that caution should be exercised, and GLP-1 receptor agonists should generally be avoided in relation to pregnancy.¹

REFERENCES

1. Nogueira, AC. So-Called “Ozempic Babies” Raise Questions About Unintended Effects of GLP-1 Agonists. Pharmacy Times. October 3, 2024. Accessed October 28, 2024. https://www.pharmacytimes.com/view/so-called-ozempic-babies-raise-questions-about-unintended-effects-of-glp-1-inhibitors

2. Epic Research. No Rise in Pregnancy Rates in the Year Following GLP-1 Prescription. News release. October 22, 2024. Accessed October 28, 2024. https://www.epicresearch.org/articles/no-rise-in-pregnancy-rates-in-the-year-following-glp-1-prescription

3. McGovern, G. Babies of Mothers Prescribed GLP-1s Prior to Pregnancy May Have Increased Risk of NICU Stays. Pharmacy Times. July 1, 2024. Accessed October 28, 2024. https://www.pharmacytimes.com/view/babies-of-mothers-prescribed-glp-1s-prior-to-pregnancy-may-have-increased-risk-of-nicu-stays