The Food and Drug Administration (FDA) recently added a boxed warning to the osteoporosis drug denosumab (Prolia) due to the heightened risk of severe hypocalcemia in patients with advanced chronic kidney disease (CKD). The agency’s decision, based on new evidence and a JAMA review, notes that denosumab increases the risk of severe hypocalcemia compared to bisphosphonates, particularly in CKD patients on dialysis. Severe hypocalcemia can manifest with symptoms like confusion, seizures, irregular heart rhythm, fainting, face twitching, muscle spasms, weakness, tingling, or numbness. Data showed a 20-times higher risk of severe hypocalcemia with denosumab compared to oral bisphosphonates. The FDA warns of potential serious harm, including hospitalization and death, and advises increased monitoring of blood calcium levels and potential use of supplements during denosumab treatment for advanced CKD patients.
Watch your step: Administered via injection every 6 months—usually for postmenopausal women with osteoporosis and risks for fractures—denosumab ranks in the top two drugs to treat osteoporosis with its use increasing steadily since its FDA approval in 2010. It works by blocking the protein receptor activator of nuclear factor kappa beta and preventing osteoclasts from breaking down bone in the body. About 10 million Americans have osteoporosis.