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Chlorambucil Pregnancy and Breastfeeding Warnings

Chlorambucil is also known as: Leukeran

Medically reviewed on Sep 24, 2018

Chlorambucil Pregnancy Warnings

Urogenital malformations, including absence of a kidney, were found in fetuses in animal studies. Unilateral renal agenesis has been observed in 2 offspring whose mothers received this drug during the first trimester. There are no adequate and well-controlled studies in pregnant women.

AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

US FDA pregnancy category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

This drug should be used during pregnancy only if the benefit outweighs the risk.

AU TGA pregnancy category: D
US FDA pregnancy category: D

Comments:
-This drug can harm a developing fetus.
-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.

See references

Chlorambucil Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

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


Comments:
-The effects in the nursing infant are unknown.

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.

Further information

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

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