Label Changes for:
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
- information about the new indication in men with osteoporosis and the risk of atypical fracture
8 USE IN SPECIAL POPULATIONS
- Category X to reflect the animal study findings of adverse neonatal outcomes in offspring exposed to denosumab in utero
“Who Should not Take Prolia”:
- addition: women who are or plan to become pregnant; hypersensitivity to denosumab.