FDA Adds Warning to Osteoporosis Drug for Hypocalcemia Risk

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The FDA has updated the label of the osteoporosis drug denosumab to include a boxed warning about increased risk for severe hypocalcemia in patients with advanced chronic kidney disease (CKD). This new warning is based on evidence indicating a significant risk for hypocalcemia in patients with CKD-MBD. Healthcare professionals are advised to assess patients’ kidney function before prescribing denosumab and to consider the risk of severe hypocalcemia in the context of other available treatments for osteoporosis. Prior to prescribing denosumab in patients with advanced CKD, CKD-MBD should be properly managed, hypocalcemia corrected, and patients supplemented with calcium and activated vitamin D. Close monitoring of blood calcium levels and prompt hypocalcemia management is crucial to prevent complications.

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