Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 27-30 November 2017

December 1, 2017 – PRAC starts two safety referrals and reaches conclusion on re-examination. PRAC issues warning about use of prostate cancer medicine Radium-223 dichloride in combination with Abiraterone acetate and prednisone or prednisolone. The PRAC has started an investigation on the increased risk of death and fractures reported in an ongoing clinical trial with radium-223 dichloride. The clinical trial is comparing radium-223 dichloride with placebo, both given … (leggi tutto)