Amgen osteoporosis therapy linked to low blood calcium – FDA (update)
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Updated to add Amgenâs (NASDAQ:AMGN) response.

The FDA warned Tuesday that blockbuster osteoporosis therapy Prolia developed by Amgen (AMGN), is associated with the risk of hypocalcemia that can even lead to hospitalization and death in kidney disease patients on dialysis.

The agency said it was investigating Prolia for severe hypocalcemia risk following a review of interim results from an ongoing safety study conducted by Amgen (AMGN).
Early results from a separate FDA study also indicated that dialysis patients who received Prolia injections showed a significant risk of hypocalcemia with adverse outcomes, including hospitalization and death, the agency said.
However, the FDA advised patients not to stop Prolia therapy without consulting their healthcare providers.
Commenting on the findings, Amgen (AMGN) said that the company is aware of the drug safety communication and would collaborate with the FDA and other healthcare authorities as investigations continue. 
The FDA first approved Prolia, also known as denosumab, in 2010 for osteoporosis in postmenopausal women who are at high risk for bone fracture.
In 2021, Amgen (AMGN) generated $2.2B in sales from Prolia in the U.S. with ~17% YoY growth.