Use in Pregnancy: Category D: There is no information on the drug's use in pregnancy; therefore, the drug should not be used in pregnant women or those likely to become pregnant unless the expected benefit outweighs any potential risk. If a woman receives doxorubicin during pregnancy or becomes pregnant while taking the drug, she should be apprised of the potential hazard to the fetus.
Although animal studies have not demonstrated teratogenic activity due to doxorubicin treatment, an embryotoxic action is evident. Studies with rabbits and rats have revealed a decreased weight gain and a higher incidence of resorbed foetuses. No greater incidence of gross, visceral or skeletal malformations or of post-natal deaths has been observed.
Dose-related mutagenic effects of doxorubicin have been reported to produce severe chromosomal aberrations in in vitro studies. In view of this activity, the use of this drug in pregnant women is not recommended.
Use in Lactation: Doxorubicin is secreted in breast milk. Women should be instructed not to breast-feed while undergoing treatment with doxorubicin.