In animal studies on Faslodex and pregnancy, the drug increased the chance of miscarriages when given to rats and rabbits. As a result, the FDA has classified it as a pregnancy Category D medication. However, if you are taking Faslodex and pregnancy occurs, your healthcare provider will consider the benefits and risks in your particular situation. It is worth noting that the drug is only approved for postmenopausal women.
Faslodex and Pregnancy: An Overview
Faslodex® (
fulvestrant) is generally not considered safe for women who are pregnant. In animal studies that looked at the effects of Faslodex during pregnancy, the drug caused miscarriages.
Faslodex 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 pregnancy Category C. However, a pregnancy Category D medicine may still be given to a pregnant woman if the healthcare provider believes that the benefits to the mother outweigh the possible risks to the unborn child.
Faslodex was given a pregnancy Category D rating because of problems in animal studies. When given to pregnant rats and rabbits, even low doses of Faslodex increased the chance of miscarriages.
However, there may be situations in which you and your healthcare provider decide that it is in your best interest to take Faslodex during pregnancy. It is important to remember that Faslodex is approved only for use in postmenopausal women.
Faslodex and Pregnancy: Final Thoughts
If you are pregnant or thinking of becoming pregnant while taking Faslodex, let your healthcare provider know. He or she will consider the benefits and risks of using the medication while pregnant before making a recommendation in your particular situation.