Doxil and Pregnancy

Because Doxil (liposomal doxorubicin) caused problems in studies of pregnant animals, the FDA has listed it as a pregnancy Category D medication. In these studies, Doxil increased the risk of miscarriage and embryo death. If you are pregnant, discuss your chemotherapy options with your healthcare provider. He or she can provide information about the risks of using this product in your particular situation.

Can Pregnant Women Use Doxil?

Doxil® (liposomal doxorubicin) is generally considered unsafe for use during pregnancy. In animal studies that looked at the effects of Doxil on pregnancy, the drug caused miscarriages and birth defects.
 

What Is Pregnancy Category D?

The U.S. Food and Drug Administration (FDA) uses a category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Pregnancy Category D is given to medicines that have shown clear evidence of risk to the fetus in studies.
 
Pregnancy Category D is a stronger warning than a pregnancy Category C classification. However, a pregnancy Category D medicine may still be given to a pregnant woman if the healthcare provider believes that the benefits to the woman outweigh the possible risks to the unborn child.
 
Doxil was given a pregnancy Category D rating because of problems in animal studies. When given to pregnant rats and rabbits, it increased the risk of miscarriage and embryo death. Information from studies using the nonliposomal formulation of doxorubicin indicated that the drug may also increase the risk of birth defects.
 

Final Thoughts on Doxil and Pregnancy

If you are pregnant or may become pregnant while taking Doxil, let your healthcare provider know.
 He or she will consider the benefits and risks of using the medication during pregnancy before making a recommendation in your particular situation. The decision to either continue with or skip chemotherapy during pregnancy is usually a difficult one.
 
Written by/reviewed by: Kristi Monson, PharmD; Arthur Schoenstadt, MD
Last reviewed by: Kristi Monson, PharmD
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