PRAC Recommends Restricting Use of Xofigo

The EMA’s Pharmacovigilance Risk Assessment Committee suggested that the use of the cancer treatment Xofigo (radium-223 dichloride) be restricted because of a possible risk of earlier death and an increase in fractures.

The committee recommended that the use of the prostate cancer medication be restricted to patients who have already had two treatments for metastatic prostate cancer or who cannot take other treatments.

It also confirmed its previous recommendation made in March that the treatment should not be used with Zytiga (abiraterone acetate) and prednisone/prednisolone, which stemmed from 12 worldwide reports of serious inflammatory brain disorders following Zytiga use.