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About Erythropoiesis Stimulating Agents
Contents
*About Erythropoiesis Stimulating Agents
*FDA Strengthens Safety Information For Erythropoiesis-Stimulating Agents (ESAs)
About Erythropoiesis Stimulating Agents
FDA Strengthens Safety Information For Erythropoiesis-Stimulating Agents (ESAs)
20 Mar 2007
UroToday.com- On March 9, 2007, the Food and Drug Administration issued a safety warning for all erythropoiesis-stimulating agents after a review of 4 new studies revealing a higher incidence of life-threatening events and death in cancer patients using these drugs.
Specifically, when these agents were used to reach a target hemoglobin of 12 g/dl they were found to:
1 - Increase the incidence of deep vein thrombosis when used preoperatively with the objective to decrease the need for blood transfusions (if prophylactic anticoagulation was not administered).
2 - Increase the risk of death in cancer patients with active malignant disease especially due to serious cardiovascular events.
3 - Shorten overall survival and time-to-progression in breast cancer patients receiving chemotherapy.
4 - Shorten the time-to-progression in head and neck cancer patients receiving radiation therapy.
With full cooperation from the pharmaceutical industry, the FDA plans to review the safety of these drugs in an upcoming meeting scheduled for 5/10/2007. Until then, physicians are advised to "use the lowest dose" necessary to increase the patient's hemoglobin to the "lowest level sufficient" to avoid a transfusion without "exceeding 12 g/dL".
Physicians using ESAs in the preoperative setting to avoid the need for transfusions must combine them with low-molecular weight heparin or subcutaneous heparin to offset the increased risk of deep vein thrombosis. Most importantly, they should not be used in patients with serum hemoglobins above 12 g/dL.
Reviewed by
UroToday.com Contributing Editor Ricardo F. S?nchez-Ortiz, MD
http://www.medilexicon.com/medicalnews.php?newsid=65628∞
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