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U.S. Food & Drug Administration
Continuing Education and Accreditation
Division of Learning and Organizational Development
Center for Drug Evaluation and Research

FDA Drug Safety Podcast: FDA adds Boxed Warning for increased risk of severe hypocalcemia in patients with advanced chronic kidney disease taking osteoporosis medicine Prolia (denosumab)

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Step Status
Educational Content ✘
Posttest ✘
Evaluation ✘
Starts On: Thu, 4/11/24: 12:00 AM EDT
Ends On: Sat, 4/10/27: 12:00 AM EDT
Type: Enduring Material
Credits: 0.5
Description: This enduring material discusses the newly added Black Box Warning of increased risk of severe hypocalcemia in patients with advanced chronic kidney disease for the osteoporosis medicine, Prolia (denosumab). It will cover common symptoms to watch out for in patients experiencing severe hypocalcemia and discuss the complex benefit-risk considerations for this patient population when taking Prolia.
Objectives:
  • Identify patients who may be at risk of severe hypocalcemia when using Prolia.
  • Describe the risks associated with using Prolia in patients with chronic kidney disease.
  • Outline strategies to mitigate the risk of severe hypocalcemia events in patients taking Prolia.
Additional Information: Review the Activity Announcement for additional details: Announcement Form