(Reuters) -The U.S. Food and Drug Administration has added a serious warning on the prescribing information for Amgen’s drug to treat bone loss about the risk of severely low calcium level in certain patients.
The so-called boxed warning, issued on Friday, comes after the health regulator in 2022 started a review into the risk of very low blood calcium in patients with advance chronic kidney disease, particularly ones on dialysis, and Amgen’s drug Prolia.
The FDA reviewed 25 cases between July 2010 through May 2021 during the investigation.
Prolia was approved in 2010 to treat bone loss in postmenopausal women and later approved to treat men and women at high risk of fracture.
Boxed warnings are the strictest warning issued by the FDA regarding the potential serious side effect from the use a drug.
(Reporting by Khushi Mandowara in Bengaluru; Editing by Shilpi Majumdar and Sriraj Kalluvila)
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