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Warning about use of prostate cancer medicine Xofigo in combination with Zytiga and prednisone or prednisolone

Ongoing clinical trial shows an increased risk of death and fractures

The European Medicines Agency (EMA) is investigating an increased risk of death and fractures reported in an ongoing clinical trial with the prostate cancer medicine Xofigo (radium-223 dichloride). The clinical trial is comparing Xofigo with placebo (a dummy treatment), both given in combination with Zytiga (abiraterone acetate) and prednisone/prednisolone. It includes prostate cancer patients with no symptoms or only mild symptoms, such as pain.

EMA will review the full results of this study as well as other available data to evaluate their impact on the authorised use of Xofigo. While a full investigation is ongoing, doctors are asked not to use Xofigo in combination with Zytiga and prednisone/prednisolone to treat metastatic castration-resistant prostate cancer patients. Patients who are currently being treated with Xofigo and have any questions about their treatment should contact their doctor.

For more information:

Warning about use of prostate cancer medicine Xofigo

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