The FDA is investigating the risk of severe hypocalcemia with serious outcomes, including hospitalization and death, in patients with advanced kidney disease on dialysis treated with the osteoporosis medicine Prolia (denosumab). FDA's review of interim results from an ongoing safety study of Prolia suggests an increased risk of hypocalcemia, or low calcium levels in the blood, in patients with advanced kidney disease. Preliminary results from a separate internal FDA study further investigating hypocalcemia in dialysis patients treated with Prolia show a substantial risk with serious outcomes, including hospitalization and death.
Because of the frequency and seriousness of these risks, the FDA is alerting health care professionals and patients about them and is continuing to evaluate this potential safety issue with Prolia use in patients with advanced kidney disease, particularly those on dialysis. The FDA will communicate the final conclusions and recommendations when the review is completed and there is more information to share.
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