Since 2015 and up to and including June 2020, 44 cases of vertebral fracture, including multiple fractures, have been reported in the UK in post-marketing settings in patients after stopping or delaying ongoing treatment with denosumab (Prolia). The figures were reported in a drug safety update from the Medicines and Healthcare products Regulatory Agency (MHRA).
The update said, where reported, these fractures occurred within 18 months of stopping or delaying denosumab treatment, with some in the first nine months. The fractures were described as life-changing in some cases.
The MHRA has issued the following advice to health care professionals:
- An increased risk of multiple vertebral fractures has been reported within 18 months of stopping or delaying denosumab 60 mg.
- Patients with a previous vertebral fracture may be at the highest risk.
- Evaluate a patient’s individual factors for benefits and risks before initiating treatment with denosumab, particularly in patients at increased risk of vertebral fractures, for example, those with previous vertebral fracture.
- Patients should not stop denosumab without specialist review.
- The optimal duration of denosumab treatment has not been established; re-evaluate the need for continued treatment periodically based on the expected benefits and potential risks on an individual basis, particularly after five or more years of use.
- Risks of long-term treatment with denosumab include osteonecrosis of the jaw and atypical femoral fractures. Osteonecrosis of the external auditory canal has also been reported.
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