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Human papillomavirus vaccine Pregnancy and Breastfeeding Warnings

Human papillomavirus vaccine is also known as: Cervarix, Gardasil, Gardasil 9

Human papillomavirus vaccine Pregnancy Warnings

Use is not recommended.

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

Comments:
-Women who are pregnant or trying to become pregnant are advised to postpone vaccination until the completion of pregnancy.

Animal studies showed no adverse effects on the offspring and no effects on fertility. There are no adequate and well-controlled studies in pregnant women. Human pregnancies that occurred during clinical trials (study drug administration was delayed until resolution of pregnancy during clinical trials) had adverse event (spontaneous abortion, late fetal death, or congenital anomaly) rates that were similar in both the active drug and placebo groups.

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 B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

See references

Human papillomavirus vaccine Breastfeeding Warnings

Use is considered acceptable; caution is recommended.

Excreted into human milk: Unknown
Excreted into animal milk: Probable

See references

References for pregnancy information

  1. "Product Information. Gardasil (human papillomavirus vaccine)." Merck & Company Inc, West Point, PA.
  2. "Product Information. Cervarix (human papillomavirus vaccine)." GlaxoSmithKline, Research Triangle Park, NC.
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  4. Cerner Multum, Inc. "Australian Product Information." O 0
  5. "Product Information. Gardasil 9 (human papillomavirus vaccine)." Merck & Company Inc, Whitehouse Station, NJ.

References for breastfeeding information

  1. "Product Information. Cervarix (human papillomavirus vaccine)." GlaxoSmithKline, Research Triangle Park, NC.
  2. "Product Information. Gardasil (human papillomavirus vaccine)." Merck & Company Inc, West Point, PA.
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  4. Cerner Multum, Inc. "Australian Product Information." O 0
  5. "Product Information. Gardasil 9 (human papillomavirus vaccine)." Merck & Company Inc, Whitehouse Station, NJ.

Further information

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

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