2024-01-19 11:52:40 ET
The U.S. Food and Drug Administration has issued a boxed warning on the prescribing information for Amgen's ( NASDAQ: AMGN ) osteoporosis drug, Prolia (denosumab), Reuters reported on Friday.
Boxed warnings are the most serious warnings issued by the U.S. health regulator regarding the potential serious side effect from the use a drug.
Prolia was approved in 2010 to treat postmenopausal women with osteoporosis at high risk for bone fracture. The drug was later approved to treat men and women at high risk of fracture.
The boxed warning comes after the FDA in 2022 started investigating the risk of severe hypocalcemia in patients with advanced kidney disease on dialysis treated with Prolia.
FDA's review of interim results from an ongoing safety study of Prolia suggested an increased risk of hypocalcemia in patients with advanced kidney disease.
Preliminary results from a separate internal FDA study further investigating hypocalcemia in dialysis patients treated with Prolia show a substantial risk with serious outcomes, including hospitalization and death.
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FDA issues boxed warning for Amgen's osteoporosis drug