"Risk of severe hypocalcemia" in Patients on Dialysis Receiving Osteoporosis Drug Prolia (denosumab)
The FDA is in the process of evaluating the osteoporosis drug Prolia (denosumab) to determine the need for regulatory action as regards a Prolia - hypocalcemia side effect safety signal according to this recent FDA information, "October - December 2022 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)".
This relatively new Prolia - hypocalcemia side effect issue first came to our attention late last year with the release of this November 22, 2022 document, "FDA Drug Safety Communication: FDA investigating risk of severe hypocalcemia in patients on dialysis receiving osteoporosis medicine Prolia (denosumab)".
For some background and context, we refer you to this November 2022 Medscape article, "FDA Alert: 'Substantial' Hypocalcemia Risk with Prolia Use in Dialysis Patients":
The FDA explained it issued the alert because of "the frequency and seriousness" of the risk for hypocalcemia and resulting complications. The agency noted that the risk seems most acute for people on dialysis who also receive Prolia, but the risk may also extend to people with advanced kidney disease who are not being treated with hemodialysis.
The alert stemmed from "interim results" in an ongoing safety study of Prolia that the FDA required the agent's manufacturer, Amgen, to run when the agency first approved denosumab for US marketing in 2010. The FDA said its review of these interim results suggested an increased risk of hypocalcemia with Prolia in patients with advanced kidney disease.
In addition, adverse event reports submitted to the FDA suggested in a separate, internal study that patients on dialysis treated with Prolia are at "substantial risk for severe and symptomatic hypocalcemia, including hospitalization and death."
Returning to the November 2022 FDA Drug Safety Communication about the Prolia - hypocalcemia side effect safety signal, we point out this FDA statement: "We will communicate our final conclusions and recommendations when we have completed our review or have more information to share."
Of course, we will watch for the FDA's determination on possible regulatory action as regards this Prolia - hypocalcemia side effect -- for example, stronger drug safety warnings in a revised Prolia drug label -- and report on any such developments here on Drug Injury Watch.
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