Epirubicin and Pregnancy
Animal studies on epirubicin and pregnancy show that the medication caused birth defects and miscarriages when it was given to pregnant rats. Although there is clear evidence of risk to a fetus, a healthcare provider can still prescribe the drug to a pregnant woman if he or she believes that the benefits outweigh the possible risks to the unborn child. If you are taking epirubicin and pregnancy occurs, make sure to let your healthcare provider know immediately.
Epirubicin (Ellence®) is generally considered unsafe for people who are pregnant. In animal studies that looked at the effects of epirubicin during pregnancy, the drug caused miscarriages and birth defects.
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. 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.
Epirubicin was given a pregnancy Category D rating because of problems seen in animal studies. When given to pregnant rats, epirubicin increased the risk of birth defects and miscarriages.
If you are pregnant or thinking of becoming pregnant while taking epirubicin, 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.