Benefit should outweigh risk.

AU TGA pregnancy category: B3
US FDA pregnancy category: Not assigned.

Risk summary: Insufficient data available on use of this drug in pregnant women to inform a drug-related risk.

Comments:
-Risks to mother and fetus associated with influenza during pregnancy should be considered.

Animal studies have revealed evidence of fetal abnormalities (reduced renal papilla, dilated ureters) when administered by continuous IV infusion but failed to reveal evidence of fetotoxicity when administered by IV bolus injection in rats; developmental toxicity (abortion/premature delivery) was shown at maternally toxic doses in rabbits. Animal studies have shown that this drug crosses the placenta. There are no controlled data in human pregnancy.

Pregnant women have higher risk of severe complications from influenza, which may lead to adverse pregnancy and/or fetal outcomes.

AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

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.

See references

An alternative agent may be preferred, especially while breastfeeding newborn or preterm infants.

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

Comments:
-No data available on use of this drug during breastfeeding; this drug is not likely to reach the infant's bloodstream in clinically significant amounts since it is poorly absorbed orally.
-Developmental and health benefits of breastfeeding should be considered as well as the mother's clinical need for this drug.
-The effects in the nursing infant are unknown; potential side effects in the breastfed child due to this drug or the mother's underlying condition should be considered.

See references