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XOFIGO® (radium Ra 223 dichloride) - Increased Incidence of Fractures and Trend for Increased Deaths with XOFIGO used in combination with abiraterone and prednisone/prednisolone

Issued November 8, 2018
Issue
An increased incidence of fractures and a trend for increased deaths was observed in a clinical trial assessing the concurrent initiation of XOFIGO in combination with abiraterone acetate and prednisone/prednisolone in the treatment of asymptomatic or mildly symptomatic chemotherapy-naïve patients with bone predominant metastatic castration-resistant prostate cancer.
Hazard description
Product safety