FDA Approves Anemia Therapy: Drug Produces Red Blood Cells
Price, Joyce, The Washington Times (Washington, DC)
The Food and Drug Administration has approved a drug that stimulates production of red blood cells in anemic patients prior to surgery, countering blood loss during some procedures.
The drug, marketed by Ortho Biotech under the name Procrit "essentially allows the body to act as its own blood bank by building a reserve of red blood cells," said Dr. Thomas P. Sculco, director of orthopedic surgery at the Hospital for Special Surgery in New York.
"If patients have higher red blood cell counts before their surgery, clinical evidence demonstrates they are less likely to need transfusions," he added.
Procrit, marketed under the generic name Epoetin alfa, previously received FDA approval as a treatment for anemia related to cancer chemotherapy. It also is used for anemia triggered by the drug AZT in patients infected with the AIDS virus and for anemia related to chronic kidney failure.
But now it is the first drug to receive FDA clearance to increase red blood cell levels in anemic patients scheduled to undergo certain elective surgeries that typically require donor blood.
Procrit should not be used in patients awaiting cardiac or vascular surgeries or those with uncontrolled hypertension, or high blood pressure, says Ortho Biotech, a subsidiary of Johnson & Johnson.
Dr. Sculco says Procrit, manufactured by Amgen Inc., will particularly benefit patients awaiting complex orthopedic procedures, such as hip or knee replacements, which make a "major demand on the nation's blood supply."
Federal health officials estimate that more than 400,000 hip and knee replacements will be performed this year and say blood transfusions will be required in many of them. …