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Bcg Pregnancy and Breastfeeding Warnings

Bcg is also known as: TheraCys, Tice BCG, Tice BCG Vaccine

Medically reviewed on September 11, 2017

Bcg Pregnancy Warnings

Use is contraindicated. (AU, UK)
Use is not recommended. (US)

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

Animal studies have not been conducted. There are no controlled data in human pregnancy. Because this is a live preparation, the US Centers for Disease Control and Prevention (CDC) does not recommend use during 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

Bcg Breastfeeding Warnings

Use is contraindicated. (AU, UK)
A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. (US)

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

See references

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. BCG Vaccine (BCG)." Organon Pharmaceuticals, West Orange, NJ.
  4. "Product Information. Tice BCG Vaccine (BCG (BCG vaccine))." Organon, West Orange, NJ.
  5. Briggs GG, Freeman RK. "Drugs in Pregnancy and Lactation. 10th ed." Philadelphia, PA: Wolters Kluwer Health (2015):

References for breastfeeding information

  1. "Product Information. BCG Vaccine (BCG)." Organon Pharmaceuticals, West Orange, NJ.
  2. "Product Information. Tice BCG Vaccine (BCG (BCG vaccine))." Organon, West Orange, NJ.
  3. Cerner Multum, Inc. "Australian Product Information." O 0
  4. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Further information

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

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