"The U.S. Food and Drug Administration today approved revised boxed warnings and other safety-related product labeling changes for erythropoiesis-stimulating agents (ESAs), which treat certain types of anemia. These new statements address the risks that the drugs Aranesp, Epogen and Procrit pose to patients with cancer and patients with chronic kidney failure."
For patients with cancer the box warning now includes that ESAs caused tumor growth and shortened survival time in patients with advance breast, head and neck, lumphoid and non-small cell lung cancer.
For patients with chronic kidney failure the new box warning states the ESAs should be used to maintain a hemoglobin level between 10 g/dl to 12 g/dl. Higher levels increase the risk for death and serious cardiovascular occurrences such as stroke, heart attack or heart failure.
ESAs are a bioengineered version of a natural protien made it he kidney that stimulates bone marrow to produce more red blood cells.
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» Drug Warnings and Withdrawls for 2007 from PharmaGazette
FiercePharma has compiled a list of the top 10 drugs to have who have had approval either withdrawn or been forced to add stronger warning labels, by the FDA, with respect to their pharmaceutical products. The list is based on 2006 worl... [Read More]
Tracked on: December 5, 2007 2:41 PM | Permalink to Trackback