Strengthened Warnings For Fracture Risk After Discontinuation Of Denosumab (prolia And Biosimilars)
Summary Denosumab (Prolia and biosimilar versions) used to treat osteoporosis now has strengthened warnings about an increased risk of multiple spinal fractures if treatment is stopped or delayed. This safety update affects people across Australia who are taking or considering this medication for osteoporosis. The updated warning emphasizes information that was previously included but is now being highlighted more prominently.
- Reason
- 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.
- Classification
- Class II
- Category
- drug recall
- Country
- Australia
- Agency
- Therapeutic Goods Administration
- Recall date
- 2025-11-21
- Status
- Ongoing
- Distribution
- Australia-wide
Official recall notice from Therapeutic Goods Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/5e6079ef-66f5-480b-aeb2-fe83648024b3