CSHS WWW HOME | MS EXCHANGE LOG ON | PULSE ARCHIVES
Medical Staff Pulse is
a Publication of the Chief of Staff
Pharmacy Focus

Change in Boxed Warnings for Aranesp and EPOGEN/PROCRIT

Amgen and the FDA have notified healthcare professionals of changes to the Boxed Warnings for Aranesp and EPOGEN/PROCRIT. In the warnings, the Increased Mortality and/or Tumor Progression section of the Aranesp and EPOGEN/PROCRIT labeling was updated with information describing the results of two additional studies showing increased mortality and more rapid tumor progression in patients with cancer receiving ESAs.

Based on the results of these studies, the prescribing information has been revised as follows: ESAs shortened overall survival and/or time to tumor progression in clinical studies in patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers when dosed to target a hemoglobin of greater than/equal to 12 g/dL.

Read the complete 2008 MedWatch Safety Summary including a link to the manufacturer's Dear Healthcare Professional Letter regarding this issue at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#ESA