The FDA will investigate the risk of severe hypocalcemia that results in hospitalization and death with Amgen's osteoporosis drug, Prolia (denosumab).
Ongoing safety research on Prolia suggests an increased risk of low calcium levels in the blood of patients with advanced kidney disease undergoing dialysis, the FDA said Nov. 22. The twice-a-year drug was approved in 2010 to treat postmenopausal women with osteoporosis at high risk for bone fracture and was later approved to treat men with osteoporosis and other conditions.
As the agency conducts its investigation, the FDA said providers should consider the potential risk for patients on dialysis, frequently monitor blood calcium levels and ensure patients are supplementing adequate amounts of vitamin D and calcium.