Skip to Content

Metformin / sitagliptin Pregnancy and Breastfeeding Warnings

Metformin / sitagliptin is also known as: Janumet, Janumet XR

Metformin / sitagliptin Pregnancy Warnings

Animal studies have failed to reveal evidence of fetal harm. There are no adequate and well controlled studies in pregnant women with metformin-sitagliptin. AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details. US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

AU/UK: Use of metformin-sitagliptin is not recommended. US: Use metformin-sitagliptin only if clearly needed and benefit outweighs risk. AU TGA pregnancy category: C US FDA pregnancy category: B Safety has not been established. If pregnancy occurs or if a patient plans to become pregnant, treatment discontinuation is recommended and insulin treatment should be initiated promptly.

See references

Metformin / sitagliptin Breastfeeding Warnings

UK: Use of metformin-sitagliptin is contraindicated. AU: Use of metformin-sitagliptin should be avoided. US: Caution is recommended. Excreted into human milk: Yes (Metformin, in small amounts); unknown (sitagliptin) Excreted into animal milk: Yes (metformin and sitagliptin)

See references

References for pregnancy information

  1. "Product Information. Janumet (metformin-sitagliptin)." Merck & Company Inc, West Point, PA.

References for breastfeeding information

  1. "Product Information. Janumet (metformin-sitagliptin)." Merck & Company Inc, West Point, PA.

Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Wolters Kluwer Health and is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective, or appropriate for any given patient. Multum Information Services, Inc. does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. Copyright 2000-2008 Multum Information Services, Inc. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.