Generic selectors
Exact matches only
Search in title
Search in content
Post Type Selectors
Filter by Categories
BioBlast®
Biosimilars Deals 2023
Biosimilars Deals 2024
Chris Vindurampulle
Diversity
Masterclasses
Other Podcasts
Other Updates
Our Awards
Patent Case Summaries
Patent Litigation
Patents
Paul Johns
PipCast®
PTE
Trade Marks
Webinars

FDA adds boxed warning for Amgen’s Prolia® (denosumab)

Jan 19, 2024

The US Food and Drug Administration (FDA) announced that it is adding a Boxed Warning to the prescribing information for Amgen’s Prolia® (denosumab) about the significant risk of developing severe hypocalcemia (very low blood calcium levels) in patients with advanced chronic kidney disease, particularly patients on dialysis.

The FDA announced its investigation into this risk in November 2022.  Prolia® is approved in the US for the treatment of osteoporosis in men and women, and to increase bone mass in patients receiving certain therapies for prostate cancer and breast cancer.