24/11/2025
⚠️Safety alert - Strengthened warnings for fracture risk after discontinuation of denosumab (Prolia and biosimilars)⚠️
The safety information for denosumab products used to treat osteoporosis has been updated to strengthen the existing warning for multiple spinal fractures after discontinuation or delay of treatment.
Denosumab (Prolia and equivalent ‘biosimilar’ products) is administered as a six-monthly injection. New spinal fractures have occurred as early as 7 months after the last dose of denosumab.
People being treated with denosumab should not stop or delay treatment without speaking to their doctor.
Prescribers should consider switching patients to an alternative therapy if treatment is discontinued.
Read more: https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts/strengthened-warnings-fracture-risk-after-discontinuation-denosumab-prolia-and-biosimilars