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News about Osteoporosis drug from FDA

Warning about Osteoporosis Drug for Hypocalcemia Risk. The information presented below is courtesy of Medscape.

FDA adds Boxed Warning for increased risk of severe hypocalcemia in patients with advanced chronic kidney disease taking osteoporosis medicine Prolia (denosumab). Patients on dialysis or with mineral and bone disorder at highest risk

"Denosumab is a monoclonal antibody, indicated for the treatment of postmenopausal women with osteoporosis who are at increased risk for fracture for whom other treatments aren't effective or can't be tolerated. It's also indicated to increase bone mass in men with osteoporosis at high risk for fracture, treat glucocorticoid-induced osteoporosis in men and women at high risk for fracture, increase bone mass in men at high risk for fracture receiving androgen-deprivation therapy for nonmetastatic prostate cancer, and increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer."

"The new warning advises healthcare professionals to assess patients' kidney function before prescribing denosumab, and for those with advanced CKD, 'consider the risk of severe hypocalcemia with Prolia in the context of other available treatments for osteoporosis'."


Be well


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