Influenza virus vaccine, live Pregnancy and Breastfeeding Warnings
Brand names: FluMist, FluMist Quadrivalent
Medically reviewed by Drugs.com. Last updated on Sep 30, 2024.
Influenza virus vaccine, live Pregnancy Warnings
The manufacturer makes no recommendation regarding use during pregnancy.
US FDA pregnancy category: Not assigned.
Risk summary: There are insufficient data available on use of this drug in pregnancy to inform a drug related risk.
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.
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.
Influenza virus vaccine, live Breastfeeding Warnings
Use is not recommended.
Excreted into human milk: Unknown
Excreted into animal milk: Data not available
Comments:
-This vaccine was not systemically absorbed after intranasal administration.
See also
References for pregnancy information
- (2024) "Product Information. FluMist 2024-2025 (influenza virus vaccine, live)." Medimmune Inc
- (2024) "Product Information. Fluenz (influenza vaccine, live)." AstraZeneca UK Ltd
References for breastfeeding information
- (2024) "Product Information. FluMist 2024-2025 (influenza virus vaccine, live)." Medimmune Inc
- (2024) "Product Information. Fluenz (influenza vaccine, live)." AstraZeneca UK Ltd
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.