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Semaglutide Pregnancy and Breastfeeding Warnings

Semaglutide is also known as: Ozempic, Rybelsus

Medically reviewed by Drugs.com. Last updated on Jan 10, 2018.

Semaglutide Pregnancy Warnings

Animal studies in pregnant rats have shown embryofetal mortality, structural abnormalities, and alterations to growth when administered during organogenesis at maternal exposures below the maximum recommended human dose (MRHD). Early pregnancy losses and structural abnormalities were observed in rabbits at below the MRHD and at 5-fold or greater in cynomolgus monkeys; in both species these findings coincided with a marked maternal body weight loss. There are no adequate and well-controlled studies in pregnant women.

Clinical considerations: Poorly controlled diabetes during pregnancy increases the maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery, stillbirth and delivery complications and increases the fetal risk for major birth defects, stillbirth, and macrosomia related morbidity. In the US, the estimated background risk of major birth defects is 6% to 10% in women with pre-gestational diabetes with an HbA1c greater than 7 and as high as 20% to 25% in women with a HbA1c greater than 10.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

Benefit should outweigh risk

US FDA pregnancy category: Not assigned

Risk summary: There are limited data in pregnant women to inform a drug-associated risk; however, based on animal data, there may be potential risks to the fetus from exposure during pregnancy.

Comments:
-Women of childbearing potential should be encouraged to use contraception during therapy; if pregnancy is desired, stop treatment at least 2 months prior to a planned pregnancy due to its long washout period.
-Poorly controlled diabetes during pregnancy is associated with both maternal and fetal risks.

See references

Semaglutide Breastfeeding Warnings

Benefit should outweigh risk

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments: The developmental and health benefits of breastfeeding should be considered along with the mother's need for therapy and any potential adverse effects on the breastfed infant.

In lactating rats, this drug was detected in milk at levels 3 to 12-fold lower than maternal plasma. There are no data on the presence of this drug in human milk, the effects on milk production, or the effects on the breastfed infant. It is assumed that because this drug is a peptide molecule and is over 99% protein bound, if excreted, the amount in milk would be low. Additionally, it is believed that if excreted in milk, infant absorption would be unlikely as it would probably be destroyed in the infant's gastrointestinal tract.

See references

References for pregnancy information

  1. "Product Information. Ozempic (1 mg dose) (semaglutide)." Novo Nordisk Pharmaceuticals Inc, Princeton, NJ.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
  3. "Product Information. Ozempic (1 mg dose) (semaglutide)." Novo Nordisk Pharmaceuticals Inc, Princeton, NJ.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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