Abraxane and Pregnancy: An Overview
Abraxane® (
protein-bound paclitaxel) is generally considered unsafe for women who are pregnant. In animal studies that looked at the effects of Abraxane during pregnancy, the drug caused miscarriages and birth defects.
Abraxane 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. 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.
Abraxane was given a pregnancy Category D rating because of problems in animal studies. When given to pregnant rats, Abraxane increased the risk of birth defects and miscarriages.
Additionally, the manufacturer of Abraxane recommends that men not father a child while taking the drug.
If you are pregnant or thinking of becoming pregnant while taking Abraxane, 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.