A January 2024 Prolia drug label change that added a “Black-Box” warning for the “new” Prolia hypocalcemia side effect was announced through this Drug Safety Communication “FDA adds Boxed Warning for increased risk of severe hypocalcemia in patients with advanced chronic kidney disease taking osteoporosis medicine Prolia (denosumab).”
This Prolia drug label change followed the publication of a January 2024 JAMA Original Investigation article, “Severe Hypocalcemia With Denosumab Among Older Female Dialysis-Dependent Patients”. In summary, it presents evidence of a Prolia increased risk of hypocalcemia in patients with chronic kidney disease (CKD) that can be 20 times higher than bisphosphonate pills.
To make clear the significance of these Prolia hypocalcemia side effect findings, and why the FDA mandated a Prolia “Black-Box” warning, we turn to this January 19, 2024, MedPage Today news report, “Calcium Levels Quickly Become Critical for Many Denosumab-Treated Women on Dialysis”:
Many women on dialysis quickly developed severe hypocalcemia after starting denosumab (Prolia) for osteoporosis, Medicare data showed.
During the first 12 weeks of treatment, 41.1% of women on [Prolia (denosumab)] developed severe hypocalcemia compared with 2.0% of those taking oral bisphosphonates, reported a group of largely FDA researchers led by Steven Bird, PhD, PharmD, of the agency offices in Silver Spring, Maryland.
This translated to more than a 20-times higher risk for incident severe hypocalcemia with [Prolia (denosumab)] (weighted risk ratio 20.7, 95% CI 13.2-41.2), according to the retrospective cohort study in JAMA.
We will continue to monitor this still-developing Prolia drug safety issue involving severe hypocalcemia in Porlia patients with advanced chronic kidney disease (CKD).
Lastly, we have started to investigate possible drug injury lawsuits for patients with advanced chronic kidney disease (CKD) taking Prolia who developed this severe hypocalcemia side effect.
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