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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.
We conducted a comprehensive investigation following recent reports raising concerns about the level of awareness and clarity regarding management of multiple spinal fractures following discontinuation or delay of the medicine.
The investigation involved seeking independent advice from the Advisory Committee on Medicines. In line with their advice, the Product Information and Consumer Medicine Information documents have been strengthened regarding the risk of multiple spinal fractures following discontinuation or delay of denosumab treatment.
For more detailed information written for health professionals, see this Medicine Safety Update article.