FDA Alert: 'Substantial' hypocalcemia risk with Prolia use in dialysis patients MedTwitter
In its alert, the FDA advised clinicians to make sure that people on dialysis who receive Prolia ingest adequate calcium andsupplementation and undergo frequent blood calcium monitoring,"possibly more often than is already being conducted," which"may help decrease the likelihood or severity of these risks."
The FDA had a similar message for people being treated with dialysis who are also receiving Prolia. The alert advised patients to watch for these symptoms and to tell their healthcare provider if they occur. The agency also advised patients who are undergoing dialysis and receiving Prolia to not stop the agent on their own, without first discussing this step with their care provider.
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 agencyfor 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.
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