FDA adds boxed warning of increased severe hypocalcemia risk for denosumab

The FDA has added a boxed warning to denosumab (Prolia, Amgen) due to an increased risk for severe hypocalcemia for people with advanced chronic kidney disease (CKD), particularly those on dialysis. A study published in JAMA found that women on dialysis who initiated treatment with denosumab had a higher risk for severe hypocalcemia compared to women who received oral bisphosphonates. The FDA recommends that patients with advanced CKD, especially those on dialysis, frequently monitor their calcium level, particularly in the 2 to 10 weeks after each denosumab injection. Providers should assess kidney function before prescribing denosumab for osteoporosis treatment and consider the risk of severe hypocalcemia in the context of other available treatments for osteoporosis in people with advanced CKD.

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