The FDA has added a serious warning to the prescribing information for Amgen Inc’s (NASDAQ:AMGN) drug Prolia (denosumab), emphasizing an increased risk of severely low calcium levels in specific patient groups.
Amgen’s Prolia, initially approved in 2010 for treating bone loss in postmenopausal women and later sanctioned for use in men and women at high risk of fracture, has generated substantial sales, amounting to $986 million in the third quarter.
Reuters noted that the boxed warning, the strictest cautionary measure issued by the FDA, was implemented following a 2022 review ...