What are Amgen, Inc. and Ortho Biotech doing?
They have revised product labeling to include the new warnings and dosing recommendations and will issue the revised labeling with a Dear Health Care Provider letter. They have voluntarily agreed to suspend broadcast (radio and television) direct-to-consumer advertising for Aranesp, Procrit, and Epogen regarding uses in cancer, with the exception of safety information, under after the May 2007 ODAC meeting. Amgen and Ortho Biotech agreed to inform all investigators conducting company-sponsored or supported studies of these data, to revise investigational drug brochures, and to participate in the May 2007 ODAC meeting. 7. What should physicians and healthcare professionals do with this information? Physicians should discuss this information with patients in clinical studies and should ask patients to confirm their consent for continued participation. Institutional Review Boards should also be advised of these findings. Investigators should re-evaluate whether clinical investigations sho
