Epogen and Pregnancy
At this time, it is not fully known whether it is safe for pregnant women to take Epogen. In studies on Epogen and pregnancy, the drug increased the risk of delayed development, missing vertebrae, and low birth weight when it was given to pregnant rats. Healthcare providers should only prescribe Epogen to a pregnant woman if the benefits outweigh the risks.
Epogen® (epoetin alfa) is an injectable prescription drug used for the treatment of anemia. In studies, Epogen was shown to cause problems when given to pregnant animals.
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 C is given to medicines that have not been studied in pregnant humans but that do appear to cause harm to the fetus in animal studies. Also, medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
Epogen was given a pregnancy Category C classification because it caused problems in animal studies. Giving the drug to pregnant rats increased the risk of low birth weight, delayed development, and missing vertebrae (spinal bones).
However, it is important to note that animals do not always respond to medicines the same way that humans do. Therefore, a pregnancy Category C medicine may be given to a pregnant woman if the healthcare provider believes that the benefits to the woman outweigh any possible risks to the unborn child.
If you are pregnant or are thinking of becoming pregnant while taking Epogen, 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.