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.

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)

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