Influenza virus vaccine, h5n1 Pregnancy and Breastfeeding Warnings

Brand names: Audenz

Influenza virus vaccine, h5n1 Pregnancy Warnings

Benefit should outweigh risk.

US FDA pregnancy category: Not assigned

Risk summary: Malformative risk with the use of this drug in pregnant patients is unlikely.

Comments:
-Pregnant patients infected with influenza are at increased risk of severe illness compared to non-pregnant women.
-Pregnant patients with influenza may have increased risk of adverse pregnancy outcomes, including preterm labor and delivery.

Animal studies did not show evidence of harm to the fetus or offspring. There are no controlled data in human pregnancy.

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

Influenza virus vaccine, h5n1 Breastfeeding Warnings

Benefit should outweigh risk.

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

Comments:
-The US CDC and several health professional organizations state that vaccines given to a nursing individual do not affect the safety of breastfeeding for patients or infants and that breastfeeding is not a contraindication to the inactivated (injected) influenza vaccine.
-Vaccination of the breastfeeding patient increases influenza antibodies and influenza-specific CD8 T-cells in breastmilk, which may offer added protection to the breastfed infant against influenza.

See references

Further information

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