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Aranesp and Pregnancy
In studies on Aranesp and pregnancy, the medicine increased the risk of very early miscarriages and low birth weight when it was given to pregnant rats. Although animals do not always respond to drugs the same way that humans do, healthcare providers prescribe Aranesp to pregnant women only if the benefits outweigh the possible risks.
Aranesp® (darbepoetin alfa) is a medication used to treat anemia cauesd by chemotherapy or chronic kidney failure. In animal studies that looked at the effects of Aranesp during pregnancy, the drug increased the risk of certain problems.
The U.S. Food and Drug Administration (FDA) uses a pregnancy 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 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.
Aranesp was given a pregnancy Category C classification because of problems in animal studies. When given to pregnant rats, Aranesp increased the risk of very early miscarriages and low birth weight. It did not appear to increase the risk of birth defects.
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 pregnant woman outweigh any possible risks to the unborn child.
If you are pregnant or thinking of becoming pregnant while taking Aranesp, 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
Last reviewed by: Kristi Monson, PharmD