HQ Team
November 25, 2022: The FDA is probing a drug, Prolia, used for the treatment of advanced kidney disease after initial investigations showed “a substantial risk with serious outcomes.”
The US health regulator is looking into the risk of severe hypocalcemia or low calcium levels in the blood of patients administered with Prolia, according to a statement.
The outcomes include hospitalisation and death in patients with advanced kidney disease on dialysis treated with the osteoporosis medicine Prolia or denosumab.
“Preliminary results from a separate internal FDA study further investigating hypocalcemia in dialysis patients treated with Prolia show a substantial risk with serious outcomes,” according to the FDA statement.
The regulator advised healthcare professionals to consider the risks of hypocalcemia with the use of Prolia in patients on dialysis.
“When Prolia is used in these patients, adequate calcium and vitamin D supplementation and frequent blood calcium monitoring, possibly more often than is already being conducted, may help decrease the likelihood or severity of these risks.”
Bone fracture
Prolia is a prescription medicine approved in June 2010 to treat postmenopausal women with osteoporosis at high risk for bone fracture.
It was later approved to treat men with osteoporosis, glucocorticoid-induced osteoporosis and bone loss in men receiving androgen deprivation therapy for prostate cancer. The drug treats women who are receiving aromatase inhibitor therapy for breast cancer.
Prolia blocks a protein and helps prevent bone cells called osteoclasts from breaking down bone in the body. It is administered by injection once every six months.
Advise patients on dialysis to immediately seek help if they experience symptoms of hypocalcemia.
“When FDA first approved Prolia, we required the manufacturer, Amgen, to conduct a long-term safety study in women with postmenopausal osteoporosis and men with osteoporosis.”
The safety study found an increased risk of hypocalcemia in patients with advanced kidney disease.
