Is Ozempic (semaglutide) safe to use during pregnancy?

Ozempic (Semaglutide) Use During Pregnancy

Ozempic (semaglutide) should not be used during pregnancy as the potential risks to the fetus outweigh the benefits. 1

Safety Concerns

• Semaglutide should be discontinued at least 2 months before a planned pregnancy due to its long washout period 1
• Animal reproduction studies show concerning findings at doses below or similar to human therapeutic doses:
  • Embryofetal mortality and structural abnormalities in rats at exposures below maximum recommended human dose 1
  • Early pregnancy losses and structural abnormalities in rabbits at clinically relevant exposures 1
  • Skeletal and visceral abnormalities in monkey studies at higher exposures 1

FDA Classification and Recommendations

• The FDA label clearly states that Ozempic "should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus" 1
• This cautious approach is consistent with how other medications with limited pregnancy data are handled 2
• Pregnancy is not listed as an approved indication for Ozempic, and its use would be considered off-label 1

Alternative Management During Pregnancy

• For pregnant women with diabetes, insulin therapy is the preferred treatment during pregnancy 2
• Unlike GLP-1 receptor agonists, insulin has been extensively studied in pregnancy and has a well-established safety profile 2
• Poorly controlled diabetes during pregnancy increases maternal risks (ketoacidosis, pre-eclampsia, spontaneous abortions) and fetal risks (major birth defects, stillbirth, macrosomia) 1

Postpartum Considerations

• There are no data on the presence of semaglutide in human milk or its effects on breastfed infants 1
• Animal studies detected semaglutide in rat milk at levels 3-12 fold lower than maternal plasma, but the clinical relevance for humans is unclear 1
• The benefits of breastfeeding should be weighed against potential risks if considering resuming Ozempic postpartum 1

Clinical Approach

1. For women taking Ozempic who are planning pregnancy:

   • Discontinue Ozempic at least 2 months before attempting conception 1
   • Transition to insulin therapy if glycemic control is needed 2

2. For women taking Ozempic who become unexpectedly pregnant:

   • Discontinue Ozempic immediately upon pregnancy confirmation 1
   • Initiate insulin therapy to maintain glycemic control 2
   • Consider consultation with maternal-fetal medicine specialist for risk assessment

Common Pitfalls

• Assuming that because a medication is commonly prescribed for non-pregnant patients, it is safe in pregnancy 3, 4
• Relying on inconsistent online information sources regarding medication safety in pregnancy 5
• Continuing medications with limited pregnancy safety data when safer alternatives (like insulin for diabetes) are available 2

While there are isolated case reports of GLP-1 receptor agonist exposure during early pregnancy with normal outcomes 6, 7, these anecdotal reports do not establish safety and should not override the more substantial evidence of potential risk from animal studies and FDA recommendations 1.

Human Medical Consultant