View Entire Collection
By Clinical Topic
By State Requirement
Diabetes – Summer 2012
Future of Nursing Initiative
Heart Failure - Fall 2011
Influenza - Winter 2011
Nursing Ethics - Fall 2011
Trauma - Fall 2010
Traumatic Brain Injury - Fall 2010
Fluids & Electrolytes
Exercising its new power to order drug companies to make label changes, the FDA is requiring manufacturers to revise prescribing information for two major erythropoiesis-stimulating agents (ESAs). The drugs, epoetin alfa (Procrit, Epogen) and darbepoetin alfa (Aranesp), are approved to treat anemia in patients with renal failure and in patients with certain types of cancer being treated with chemotherapy. Epoetin alfa is also approved for several other indications.
The new labeling addresses concerns that the risks of ESA therapy may outweigh the benefits in some patients with cancer. Research shows that at certain dosages, ESAs cause tumor growth and shortened survival in patients with advanced breast, head and neck, lymphoid, and non-small-cell lung cancer. The labeling will emphasize that ESAs should be used for cancer patients only if their anemia is caused by chemotherapy, not another cause, and shouldn't be given to patients who are aiming for cure. In addition, ESAs should be used to maintain a hemoglobin level between 10 and 12 grams/dL, no higher. Research hasn't shown that higher levels are beneficial, and in patients with chronic renal failure, higher levels raise the risk of serious complications or death.
For more information on ESAs, visit http://www.fda.gov/cder/drug/infopage/RHE/default.htm.
Sign up for our free enewsletters to stay up-to-date in your area of practice - or take a look at an archive of prior issues
Join our CESaver program to earn up to 100 contact hours for only $34.95
Explore a world of online resources
Back to Top