Amgen (AMGN) Announces Update To U.S. Prescribing Information for Aranesp and EPOGEN
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Amgen (NASDAQ: AMGN) announced the U.S. Food and Drug Administration (FDA) has approved updated safety information, including a boxed warning in the prescribing information for the class of drugs known as Erythropoiesis-stimulating Agents (ESAs), including Aranesp and EPOGEN.
Updated information for patients in the revised label notes that "patients should be informed of the increased risks of mortality, serious cardiovascular events, thromboembolic events, and tumor progression when used in off-label dose regimens or populations."
The new boxed warning notes that ESAs, when administered to target a hemoglobin of greater than 12 g/dL:
Increased the risk for death and for serious cardiovascular events; Shortened the time to tumor progression in patients with advanced head and neck cancer receiving radiation therapy; and Shortened overall survival and increased deaths attributed to disease progression at four months in patients with metastatic breast cancer receiving chemotherapy.
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