TGA warning for fracture risk after discontinuation of denosumab
Australia’s Therapeutic Goods Administration (TGA) has issued a safety warning regarding the discontinuation of Prolia (denosumab), originated by US biotech major Amgen (Nasdaq: AMGN), and biosimilar versions of the drug.
The Product Information (PI) for denosumab products indicated for the treatment of osteoporosis have been updated to strengthen the existing warning for multiple vertebral fractures (MVF) following discontinuation or delay of treatment.
Denosumab is used for the treatment of osteoporosis in postmenopausal women, to increase bone mass in men with osteopenia receiving androgen deprivation therapy for non-metastatic prostate cancer, to increase bone mass in men with osteoporosis at increased risk of fracture, and to increase bone mass in women and men at increased risk of fracture due to long-term systemic glucocorticoid therapy.
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