Canagliflozin Pregnancy and Breastfeeding Warnings

Brand names: Invokana

Medically reviewed by Drugs.com. Last updated on Aug 29, 2023.

Canagliflozin Pregnancy Warnings

Not recommended during the second and third trimesters

AU TGA pregnancy category: C
US FDA pregnancy category: Not Assigned

Risk Summary: There is insufficient data in pregnant women to determine a drug-associated risk for major birth defects and miscarriage; animal data has shown adverse renal effects with administration during the renal development period which corresponds to the late second and third trimesters of human pregnancy.

Comments:
-Poorly controlled diabetes during pregnancy increases maternal and fetal risks of adverse outcomes.

In animal studies, drug exposure during periods of animal development corresponding to the late second and third trimesters of human development, showed increased kidney weights and renal pelvic and tubular dilation at doses expected during human exposure. The renal pelvic dilatations observed did not fully reverse within a 1-month recovery period. There are no adequate and well-controlled studies in pregnant women.

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 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.

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Canagliflozin Breastfeeding Warnings

Not recommended

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

Comments:
-Because of the potential for serious adverse reactions in the nursing infant, breastfeeding is not recommended while taking this drug.

Upon administering radiolabeled canagliflozin to lactating rats, a milk to plasma ratio of 1.4 was found indicating that canagliflozin may be transferred into milk at a concentration comparable to that in plasma. Since human kidney maturation occurs in utero and during the first 2 years of life (when lactational exposure may occur), there may be a risk to the developing human kidney. A risk to the developing rat kidney (renal pelvic and tubular dilations) was observed when juvenile rats were exposed to canagliflozin during maturation.

See references

Further information

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