This relatively new Prolia side effect, hypocalcemia, first came to our attention in late 2022 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)”.
From that November 2022 FDA Drug Safety Communication about the Prolia side effect hypocalcemia, 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.”
As of now, it appears the FDA is still in the process of evaluating the osteoporosis drug Prolia (denosumab) to determine the need for regulatory action as regards this Prolia side effect hypocalcemia safety signal. This is 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)” — which was labeled “Content current as of: 04/05/2023” when viewed earlier today, May 9, 2023.
We are waiting for the FDA’s determination on possible regulatory action as regards this Prolia side effect of hypocalcemia. Perhaps there will be stronger drug safety warnings in a revised Prolia drug label, for example.
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