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Arsenic trioxide Pregnancy and Breastfeeding Warnings

Arsenic trioxide is also known as: Trisenox

Medically reviewed on March 30, 2018

Arsenic trioxide Pregnancy Warnings

Animal studies have revealed embryolethality and teratogenicity, including neural-tube defects. Data from animals also show inorganic arsenicals cross the placental barrier when given orally or by injection. There are no controlled data in human pregnancy, but there is a report of one patient who had a miscarriage after becoming pregnant while receiving this drug. The effect of arsenic on fertility has not been adequately studied.

AU TGA pregnancy category X: Drugs which have such a high risk of causing permanent damage to the fetus that they should not be used in pregnancy or when there is a possibility of 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.

Avoid use in pregnant patients.

AU TGA pregnancy category: X
US FDA pregnancy category: Not Assigned

Comments:
-This drug may cause fetal harm based on findings in animals.
-Consider performing pregnancy tests prior to treatment initiation.
-Advise females of reproductive potential and males with female sexual partners of reproductive potential to use effective contraception during and after treatment with this drug.

See references

Arsenic trioxide Breastfeeding Warnings

Avoid use during breastfeeding.

Excreted into human milk: Yes

Comments: The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. "Product Information. Trisenox (arsenic trioxide)" Cephalon Inc, West Chester, PA.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Cerner Multum, Inc. "Australian Product Information." O 0

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Trisenox (arsenic trioxide)" Cephalon Inc, West Chester, 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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