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As a pregnancy Category D medication, Xgeva is generally not recommended for women who are expecting. When given to pregnant animals, this medication appeared to cause problems with bone and teeth development. Although this drug may cause problems when used during pregnancy, there may be times when the benefits outweigh the possible risks to the unborn child.

Can Pregnant Women Use Xgeva?

Xgeva® (denosumab) is a prescription medication used to prevent bone problems in people with cancer. This medicine may not be safe for use during pregnancy, although the full risks are currently unknown. Studies in pregnant animals have suggested that the drug may cause problems when used during pregnancy.

What Is 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. Xgeva is classified as a pregnancy Category D medication.
Pregnancy Category D is a classification given to medicines that have been shown to present a risk to the fetus in studies of pregnant women but may still offer benefits that outweigh the risks the drug presents. 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.
Xgeva was initially given a pregnancy Category C rating (a less serious rating), but the rating was changed to Category D after the results of animal studies suggested the drug wasn't safe for use during pregnancy.
Genetically modifying mice in such a way as to mimic the action of Xgeva appeared to cause problems in the lymph nodes of the offspring that resulted in bone and teeth formation problems. This suggests that Xgeva might cause problems with bone and teeth development if used during pregnancy. Studies of Xgeva in pregnant monkeys suggest that the drug can cause a wide variety of problems, such as:
  • Increased risk of miscarriage, stillbirth, and newborn death
  • Absent lymph nodes
  • Abnormal bone growth
  • Decreased newborn growth.
However, it is important to note that animals do not always respond to medicines in the same way that humans do. It is also important to understand that the benefits of this drug to the mother may sometimes outweigh the potential risks to the fetus.
Written by/reviewed by:
Last reviewed by: Kristi Monson, PharmD;
Last updated/reviewed:
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