Is Ozempic (semaglutide) safe to use during pregnancy?

Ozempic (Semaglutide) Use During Pregnancy

Ozempic should not be used during pregnancy and should be discontinued if pregnancy occurs, with transition to insulin therapy as the preferred treatment for glycemic control in pregnant women with diabetes. 1, 2

Safety Concerns and FDA Labeling

• The FDA label for semaglutide (Ozempic) states that there are "limited data with semaglutide use in pregnant women to inform a drug-associated risk for adverse developmental outcomes." 2
• Animal reproduction studies have shown potential risks to the fetus from semaglutide exposure during pregnancy, including:
  • Embryofetal mortality, structural abnormalities, and growth alterations in rats at maternal exposures below the maximum recommended human dose 2
  • Early pregnancy losses and structural abnormalities in rabbits and cynomolgus monkeys 2

Recommended Management Approach

• For women taking Ozempic who become pregnant or are planning pregnancy, the American College of Obstetricians and Gynecologists recommends transitioning to insulin therapy for glycemic control 1
• The American Diabetes Association specifically recommends insulin as the preferred treatment for diabetes during pregnancy due to its well-established safety profile 1
• If a woman becomes unexpectedly pregnant while taking Ozempic:
  • Discontinue Ozempic immediately 1, 2
  • Consult with a maternal-fetal medicine specialist for risk assessment 1
  • Initiate insulin therapy if glycemic control is needed 1

Evidence from Case Reports

• While there are isolated case reports of normal pregnancy outcomes after first-trimester exposure to GLP-1 receptor agonists (such as liraglutide and dulaglutide), these limited reports cannot establish safety 3, 4
• One case report of dulaglutide use in early pregnancy noted mild bilateral renal pyelectasis in the newborn, though causality cannot be established 4
• Individual case reports do not provide sufficient evidence to override the concerns raised in animal studies and the FDA labeling cautions 2

Risk-Benefit Considerations

• Approximately 90% of pregnant women use medications during pregnancy, but 10% of birth defects are directly linked to medication exposure 5
• The estimated background risk of major birth defects is 6-10% in women with pre-gestational diabetes with HbA1c >7%, and as high as 20-25% with HbA1c >10% 2
• Poorly controlled diabetes during pregnancy increases risks of maternal complications (diabetic ketoacidosis, pre-eclampsia, spontaneous abortions) and fetal complications (major birth defects, stillbirth, macrosomia) 2
• Given these risks, achieving glycemic control is essential, but should be done with medications that have established safety profiles in pregnancy 1, 2

Common Pitfalls and Caveats

• Assuming that all diabetes medications are interchangeable during pregnancy can lead to unnecessary fetal exposure to potentially harmful agents 1, 5
• Delaying the transition from Ozempic to insulin after pregnancy is confirmed may increase fetal exposure and potential risks 2
• Failing to consult with maternal-fetal medicine specialists when Ozempic exposure has occurred during pregnancy may miss opportunities for enhanced monitoring and risk assessment 1
• The misconception that medications available without prescription (OTC) are safe during pregnancy does not apply to prescription medications like Ozempic, which requires even more caution 6, 5