Osteoporosis Home > Prolia and Pregnancy

In animal studies on Prolia (denosumab) and pregnancy, the medicine caused many problems in the offspring. As a result, this medication was classified as a pregnancy Category X drug, meaning it is not safe for use in pregnant women.

Can Pregnant Women Take Prolia?

Prolia® (denosumab) is a prescription osteoporosis medication. This medication may not be safe for use during pregnancy, although the full risks are not currently known. Studies in pregnant animals have suggested that the drug may cause problems when used during pregnancy.

What Is Pregnancy Category X?

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 X is given to medicines that show problems to the fetus in animal studies or in human use of the medication. With this category, the potential risks clearly outweigh the potential benefits.
Prolia was initially given a pregnancy Category C rating (a much less serious rating), but the rating was changed to a Category X 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 Prolia (by suppressing the RANKL gene) caused problems in the lymph nodes of the offspring that led to bone and teeth formation problems. This suggests that Prolia might cause problems with bone and teeth development if used during pregnancy. Studies of Prolia in pregnant monkeys caused a wide variety of problems, such as:
  • Increased risk of miscarriage, stillbirth, and newborn death
  • Absent lymph nodes
  • Abnormal bone growth
  • Decreased newborn growth.
Written by/reviewed by:
Last reviewed by: Kristi Monson, PharmD;
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