Severe Hypocalcemia Risk in Dialysis Patients With Denosumab

A study published in JAMA found that using the osteoporosis drug denosumab (Prolia) in dialysis patients significantly increases the risk of life-threatening hypocalcemia compared to other treatments. The FDA is revising the prescribing information for the drug to include a boxed warning. Patients on dialysis have a high risk for fracture and difficulty absorbing calcium, leading to a high risk for hypocalcemia. Researchers studied nearly 3000 dialysis patients, finding that patients taking denosumab had a 20 times greater risk of severe hypocalcemia compared to those taking oral bisphosphonates. Patients taking denosumab were also at a higher risk of hospitalization, seizures, and death. The FDA noted that kidney specialists are best positioned to monitor and mitigate the risks of denosumab in dialysis patients, and recommends calcium and vitamin D supplementation and close monitoring of blood calcium levels. Despite the risks, clinicians may continue using FDA-approved osteoporosis drugs off-label in patients with chronic kidney disease until more effective treatments are available.

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