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Diphtheria toxoid / hepatitis b pediatric vaccine / pertussis, acellular / poliovirus vaccine, inactivated / tetanus toxoid Pregnancy and Breastfeeding Warnings

Brand names: Pediarix

Medically reviewed by Drugs.com. Last updated on Oct 23, 2023.

Diphtheria toxoid / hepatitis b pediatric vaccine / pertussis, acellular / poliovirus vaccine, inactivated / tetanus toxoid Pregnancy Warnings

This vaccine is only approved for use in young children.

AU TGA pregnancy category: B2
US FDA pregnancy category: Not assigned

Animal studies are not available. 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 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

Diphtheria toxoid / hepatitis b pediatric vaccine / pertussis, acellular / poliovirus vaccine, inactivated / tetanus toxoid Breastfeeding Warnings

This vaccine is only approved for use in young children.

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

See references

See also

References for pregnancy information

  1. Cerner Multum, Inc. Australian Product Information.
  2. Product Information. Pediarix (DTaP-HepB IPV) (diphtheria/hepB/pertussis,acel/polio/tetanus). GlaxoSmithKline. 2022.
  3. TGA. Therapeutic Goods Administration. Australian Drug Evaluation Committee. Prescribing medicines in pregnancy: an Australian categorisation of risk of drug use in pregnancy. http://www.tga.gov.au/docs/html/medpreg.htm 2010.

References for breastfeeding information

  1. Cerner Multum, Inc. Australian Product Information.
  2. Product Information. Pediarix (DTaP-HepB IPV) (diphtheria/hepB/pertussis,acel/polio/tetanus). GlaxoSmithKline. 2022.

Further information

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

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