Animal studies involving doxorubicin and pregnancy have shown that the drug increased the risk of birth defects and miscarriages. Therefore, the FDA has given doxorubicin a pregnancy Category D classification, meaning that the drug is generally considered unsafe for women who are pregnant.
An Overview of Doxorubicin and Pregnancy
Doxorubicin hydrochloride (Adriamycin®, Doxil®) is generally considered unsafe for people who are pregnant. In animal studies that looked at the effects of doxorubicin during pregnancy, the drug caused miscarriages and birth defects.
Doxorubicin and 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.
Doxorubicin was given a pregnancy Category D rating because of problems in animal studies. When given to pregnant rats, doxorubicin increased the risk of birth defects (including problems with the esophagus, intestines, bladder, and heart) and miscarriages.
If you are pregnant or thinking of becoming pregnant while taking doxorubicin, let your healthcare provider know. He or she will consider the benefits and risks of using the medication during pregnancy before making a recommendation for your particular situation.
Written by/reviewed by: Kristi Monson, PharmD;Arthur Schoenstadt, MD
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