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Chlorambucil Pregnancy and Breastfeeding Warnings

Chlorambucil is also known as: Leukeran

Chlorambucil Pregnancy Warnings

Chlorambucil has been reported to produce human infertility. Both reversible and permanent sterility have been observed in both sexes receiving chlorambucil. A high incidence of sterility has been reported when chlorambucil has been administered to prepuberal and puberal males. Prolonged or permanent azoospermia has also been reported in adult males. Induction of amenorrhea in females by alkylating agents has also been well documented. The manufacturer has reported that chlorambucil is capable of producing amenorrhea. Autopsies of the ovaries of women with malignant lymphoma who were treated with combination therapy which included chlorambucil have reported fibrosis, vasculitis, and depletion of primordial follicles.

Chlorambucil has been assigned to pregnancy category D by the FDA. Animal studies have revealed urogenital malformations including the absence of a kidney. Evidence of human teratogenicity suggests that chlorambucil crosses the placenta. Uncontrolled human data have revealed unilateral renal agenesis in two offspring whose mothers received chlorambucil during the first trimester. Chlorambucil should only be given during pregnancy when there are no alternatives and benefit outweighs risk.

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Chlorambucil Breastfeeding Warnings

There are no data on the excretion of chlorambucil into human milk. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

See references

References for pregnancy information

  1. "Product Information. Leukeran Tablets (chlorambucil)." Glaxo Welcome, Research Triangle Pk, NC.
  2. Steege JF, Caldwell DS "Renal agenesis after first trimester exposure to chlorambucil." South Med J 73 (1980): 1414-5
  3. Marmor D, Grob-Menendez F, Duyck F, Delafontaine D "Very late return of spermatogenesis after chlorambucil therapy: case reports." Fertil Steril 58 (1992): 845-6

References for breastfeeding information

  1. "Product Information. Leukeran Tablets (chlorambucil)." Glaxo Welcome, Research Triangle Pk, NC.

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