Summary Safety Review - Denosumab (Prolia and Xgeva) - Hearing loss and deafness (English, HTML)

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Publisher-reported update

2024-05-08

A safety review was carried out after Health Canada received a report from the European Medicines Agency, which linked hearing loss and deafness to the use of Prolia and Xgeva. After review of the report, Health Canada determined that there is not enough information to make such a link. The risk of hearing loss or deafness is already listed in the prescribing information for Xgeva (less common side effect for people with advanced bone cancer), but not for Prolia.

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