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# Boxed Warning Added to Amgen’s Prolia
- URL: https://www.fdaweb.com/boxed-warning-added-to-amgens-prolia/
- Published: 2024-01-19T12:00:00.000Z
- Updated: 2026-09-14T14:20:45.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5156171

FDA is adding a Boxed Warning to Amgen’s osteoporosis drug Prolia (denosumab) about increased risk of severe hypocalcemia in patients with advanced chronic kidney disease (CKD), especially those on dialysis. “Severe hypocalcemia appears to be more common in patients with CKD who also have a condition known as mineral and bone disorder,” an agency [safety alert ](https://www.fda.gov/media/175509/download?attachment&ref=fdaweb.com)says. “In patients with advanced CKD taking Prolia, severe hypocalcemia resulted in serious harm, including hospitalization, life-threatening events, and death.” The warning is also being updated to the drug’s patient Medication Guide and Risk Evaluation and Mitigation Strategy.