| Subject: | FDA Notifies Healthcare Professionals of Changes to Prescribing Information for Aranesp and Epogen/Procrit |
| Category: | Food and Drug Administration (FDA)
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| Published: | Thu, 13 Mar 2008 - 01:00 am |
| Amgen and the FDA are notifying healthcare professionals of changes to the Boxed Warnings/WARNINGS: Increased Mortality and/or Tumor Progression section of the Aranesp and EPOGEN/PROCRIT labeling to update 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... The full article is available to StayAlert subscribers. Click here for a free trial subscription. |
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