Influenza virus vaccine, live Pregnancy and Breastfeeding Warnings

Brand names: FluMist, FluMist Quadrivalent

Medically reviewed by Drugs.com. Last updated on Aug 14, 2023.

Influenza virus vaccine, live Pregnancy Warnings

Animal studies at approximately 150 times the human dose administered intranasally either during organogenesis or prior to gestation and during organogenesis did not show fetal harm or impaired fertility. 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.

The manufacturer makes no recommendation regarding use during pregnancy.

US FDA pregnancy category: Not assigned

Comments:
-This vaccine is not systemically absorbed after intranasal administration, so fetal exposure is not expected.
-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

Influenza virus vaccine, live Breastfeeding Warnings

Use is not recommended.

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

Comments:
-Because some viruses are excreted in human milk, caution is advised.

See references

Further information

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