FDA Adds Boxed Warning to Aranesp, Procrit and Epogen

Patients taking erythropoiesis-stimulating agents need to take lowest dose to avoid transfusion

FRIDAY, March 9 (HealthDay News) -- The U.S. Food and Drug Administration has added a boxed warning to erythropoiesis-stimulating agents, including Aranesp (darbepoetin alfa), Epogen and Procrit (both epoetin alfa). Physicians should weigh the risks and benefits of the drugs, and if they use them, they should monitor and adjust patient dosage to ensure the lowest level of hemoglobin is maintained to avoid transfusion.

Several new studies have suggested that patients with chronic kidney failure may have a greater risk of mortality, stroke, blood clots and myocardial infarctions when treated with higher-than-recommended doses of the drugs. In addition, the drugs at normal or higher-than-normal doses have been linked to an increased risk of more rapid tumor growth in head and neck cancer patients; blood clots in orthopedic surgery patients; and mortality in cancer patients not currently undergoing chemotherapy.

"The new studies provide significant new information for both prescribers and patients, and the new information applies to all erythropoiesis-stimulating agents, which share the same mechanism of action," said Steven Galson, M.D. director of FDA's Center for Drug Evaluation and Research, in a statement. "The safety of these products will be discussed when the Oncologic Drugs Advisory Committee meets in May and further revisions to the labeling may occur after that meeting."

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Physician's Briefing

FRIDAY, March 9 (HealthDay News) -- The U.S. Food and Drug Administration has added a boxed warning to erythropoiesis-stimulating agents, including Aranesp (darbepoetin alfa), Epogen and Procrit (both epoetin alfa). Physicians should weigh the risks and benefits of the drugs, and if they use them, they should monitor and adjust patient dosage to ensure the lowest level of hemoglobin is maintained to avoid transfusion.

Several new studies have suggested that patients with chronic kidney failure may have a greater risk of mortality, stroke, blood clots and myocardial infarctions when treated with higher-than-recommended doses of the drugs. In addition, the drugs at normal or higher-than-normal doses have been linked to an increased risk of more rapid tumor growth in head and neck cancer patients; blood clots in orthopedic surgery patients; and mortality in cancer patients not currently undergoing chemotherapy.

"The new studies provide significant new information for both prescribers and patients, and the new information applies to all erythropoiesis-stimulating agents, which share the same mechanism of action," said Steven Galson, M.D. director of FDA's Center for Drug Evaluation and Research, in a statement. "The safety of these products will be discussed when the Oncologic Drugs Advisory Committee meets in May and further revisions to the labeling may occur after that meeting."

More Information

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