Amgen’s Prolia Boxed Warning On Hypocalcemia Risk Backed By Medicare Data

 
• By Sue Sutter

Newly expanded warning language on denosumab for advanced CKD emphasizes appropriate patient selection and need to closely monitor calcium levels. Boxed warning follows FDA drug safety communication in 2022 about hypocalcemia and two observational studies using CMS data.

Calcium test
A new boxed warning on Prolia labeling focuses on the risk of hypocalcemia in patients with kidney disease. • Source: Shutterstock

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