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Influenza virus vaccine, h1n1, inactivated Pregnancy and Breastfeeding Warnings

Influenza virus vaccine, h1n1, inactivated Pregnancy Warnings

This drug should be used during pregnancy only if clearly needed.

AU TGA pregnancy category: B2
US FDA pregnancy category: C

Comments:
-There is no data on use in pregnant women to know this drugs risks, including the risk of fetal harm or reproductive effects.

Animal studies have not been conducted. There are no controlled data in human pregnancy.

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 C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

See references

Influenza virus vaccine, h1n1, inactivated Breastfeeding Warnings

Caution is recommended.

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

Comments:
-There is no information regarding this drug on the presence in human milk, the effects on a breastfed infant, or effects on milk production.
-According to some authorities, vaccines (live, attenuated, or inactivated, including swine flu) given to nursing patients do not affect the safety of breastfeeding for the infant, and may offer added protection against influenza for the infant.
-Inactivated influenza vaccine had higher breast milk antibody responses than live influenza vaccine.

See references

References for pregnancy information

  1. "Product Information. Influenza Virus Vaccine, H1N1, Inactivated (influenza virus vaccine, H1N1, inactivated)." CSL Biotherapies, King of Prussia, PA.
  2. TGA. Therapeutic Goods Administration. Australian Drug Evaluation Committee "Prescribing medicines in pregnancy: an Australian categorisation of risk of drug use in pregnancy. Available from: URL: http://www.tga.gov.au/docs/html/medpreg.htm." ([1999]):

References for breastfeeding information

  1. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
  2. "Product Information. Influenza Virus Vaccine, H1N1, Inactivated (influenza virus vaccine, H1N1, inactivated)." CSL Biotherapies, King of Prussia, PA.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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