Arsenic trioxide Pregnancy and Breastfeeding Warnings

Arsenic trioxide is also known as: Trisenox

Arsenic trioxide Pregnancy Warnings

Arsenic trioxide has been assigned to pregnancy category D by the FDA. Animal studies have revealed that inorganic arsenicals cross the placental barrier when given orally or by injection. The reproductive toxicity of arsenic trioxide has been studied in a limited manner. An increase in resorptions, neural tube defects, anophthalmia, and microphthalmia have been reported in animal studies. There are no controlled data in human pregnancy. One patient who became pregnant while receiving arsenic trioxide had a miscarriage. Arsenic trioxide should only be given during pregnancy when there are no alternatives and benefit outweighs risk. Women of childbearing potential should be advised to avoid becoming pregnant. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.

Arsenic trioxide Breastfeeding Warnings

Arsenic is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from arsenic trioxide, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

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