Dialysis patients receiving denosumab have increased risk of severe hypocalcemia, warns FDA

Interim findings from an ongoing safety trial of Denosumab (Prolia) in patients with severe renal disease revealed an elevated risk of hypocalcemia, or low calcium levels in the blood. These findings were published in the November issue of U.S Food and Drug Administration.

A prescription drug called Prolia was licensed in June 2010 to treat postmenopausal women with osteoporosis who are at a high risk of breaking a bone. Glucocorticoid-induced osteoporosis, bone loss in males getting androgen deprivation therapy for prostate cancer, and bone loss in women receiving aromatase inhibitor therapy for breast cancer were all conditions for which Prolia was eventually authorized for the treatment. By inhibiting a protein called RANK (receptor activator of nuclear factor kappa beta), Prolia aims to stop the body's osteoclasts from destroying bone and once every six months, Prolia is injected by a medical practitioner.

Recently, FDA is looking at the possibility of severe hypocalcemia in patients with advanced renal disease who are receiving treatment for osteoporosis with Prolia having significant consequences, such as hospitalization and death (denosumab). A second internal FDA research looking at hypocalcemia in dialysis patients taking Prolia has shown early evidence of a significant risk with serious consequences, such as hospitalization and death.

From this investigation it is stated that:

1. Patients should not stop taking Prolia without first talking to a doctor since doing so might make their bone condition worse.

2. Any worries might have, including potential alternative therapies, should be discussed with a health care expert.

3. If an individual is suffering with any low blood calcium symptoms, including strange tingling or numbness in your hands, arms, legs, or feet; severe muscle cramps or spasms; voice box or lung spasms that make breathing difficult; vomiting; seizures; or an erratic heartbeat, let a medical practitioner know.

4. When prescribing Prolia to dialysis patients, medical providers should take the possibility of hypocalcemia into account.

5. Adequate calcium and vitamin D supplements, along with regular blood calcium monitoring—possibly more frequently than is currently done—can all help lessen the likelihood or severity of these concerns when Prolia is administered to these individuals.

6. Encourage dialysis patients to get aid right away if they develop hypocalcemia symptoms.

Reference:

FDA investigating risk of severe hypocalcemia in patients on dialysis receiving osteoporosis medicine Prolia (denosumab). U.S. Food and Drug Administration; FDA. November 22, 2022.