Animal studies of administration prior to mating, during organogenesis, and later in pregnancy did not show vaccine-related fetal malformations or variations, and no adverse pre-weaning developmental effects. There are no controlled data in human pregnancy. The background birth defect and miscarriage risk for the indicated population is not known. In the US general population, the estimated major birth defect risk is 2 to 4% and the miscarriage risk is 15 to 20%.

Pregnancy registries have been established for FLUARIX and FLULAVAL at 1-888-452-9622.

AU TGA pregnancy category B2: 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 are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage.

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.

Use is not recommended unless clearly needed.

AU TGA pregnancy category: B2
US FDA pregnancy category: Not assigned

Comments:
-Consult manufacturer information for specific pregnancy categories.
-There is no data on use in pregnant women to know this drugs risks.
-Pregnant patients with seasonal influenza are at increased risk of severe illness compared with non-pregnant patients, and are at increased risk of adverse pregnancy outcomes including preterm labor and delivery.

See references

Caution is recommended.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

See references