FDA Warns About Prolia in Patients with Kidney Disease

The FDA is investigating the risk of severe hypocalcemia with serious outcomes, including hospitalization and death, in patients with advanced kidney disease on dialysis treated with Amgen’s osteoporosis therapy Prolia (denosumab).

The agency’s review of interim results from an ongoing safety study of Prolia suggests an increased risk of low calcium levels in the blood in patients with advanced kidney disease. Preliminary results from a separate internal FDA study further investigating hypocalcemia in dialysis patients treated with Prolia show a substantial risk with serious outcomes, including hospitalization and death. In addition, adverse event reports submitted to FDA showed severe and symptomatic hypocalcemia, including hospitalization and death, is occurring in patients with advanced kidney disease treated with Prolia

"Patient safety is of the utmost importance at Amgen. We are aware of the FDA’s drug safety communication and are committed to collaborating with the FDA and other health authorities," an Amgen spokesperson told Formulary Watch.

Prolia is a prescription medicine approved in June 2010 to treat postmenopausal women with osteoporosis at high risk for bone fracture. Prolia was later approved to treat men with osteoporosis, glucocorticoid induced osteoporosis, bone loss in men receiving androgen deprivation therapy for prostate cancer and in women receiving aromatase inhibitor therapy for breast cancer. Prolia works by blocking a protein called RANK (receptor activator of nuclear factor kappa beta) and helps prevent bone cells called osteoclasts from breaking down bone in the body. Prolia is administered by injection once every six months.