Totality of Available Data Reaffirms PROCRIT(R) (Epoetin alfa) Is Safe and Effective When Used Appropriately as Labeled to Treat Chemotherapy-Indu...(continue to support direction to healthc...),Health

In addition to working closely with the FDA, Ortho Biotech, along with independent investigators and other ESA manufacturers, has provided data to the independent Cochrane Collaboration to facilitate a patient-level analysis of all data from appropriately designed and conducted controlled clinical studies. This project will create a database of more than 15,000 patients, making it the largest combined analysis of ESA safety data ever undertaken. The company also has proposed unrestricted funding to support independent research through the National Cancer Institute to evaluate potential mechanisms that may mediate adverse outcomes when ESAs are used to treat CIA.

About PROCRIT (Epoetin alfa)

PROCRIT is used for the treatment of anemia in patients with most types of cancer receiving chemotherapy, with chronic renal failure who are on dialysis and those who are not on dialysis, who are being treated with zidovudine for HIV infection, and to reduce the need for transfusion in anemic patients who are scheduled for elective noncardiac, nonvascular surgery. Depending on the country in which Epoetin alfa is marketed, these indications may differ.

Important U.S. Safety Information for PROCRIT

Boxed WARNINGS: INCREASED MORTALITY, SERIOUS CARDIOVASCULAR and THROMBOEMBOLIC EVENTS, and TUMOR PROGRESSION

Renal failure: Patients experienced greater risks for death and serious cardiovascular events when administered erythropoiesis-stimulating agents (ESAs) to target higher versus lower hemoglobin levels (13.5 vs. 11.3 g/dL; 14 vs. 10 g/dL) in two clinical studies. Individualize dosing to achieve and maintain hemoglobin levels within the range of 10 to 12 g/dL.

Cancer:

-- ESAs shortened overall surviv
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