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FDA Panel Weighs Safety of Anemia Drugs for Cancer Patients
Date:3/13/2008

Growing body of evidence suggests the medications speed tumor growth, shorten lives

THURSDAY, March 13 (HealthDay News) -- When a U.S. Food and Drug Administration advisory panel meets Thursday to weigh whether blood-boosting drugs are safe to use in cancer patients suffering from anemia, the question will not be an easy one to answer.

According to FDA briefing documents filed this week, there are now a total of eight clinical trials that suggest these widely used medications, sold as Epogen and Aranesp by Amgen Inc. and as Procrit by Johnson&Johnson, actually speed the growth of tumors and shorten the lives of cancer victims. Known as erythropoiesis-stimulating agents (ESAs), they work by stimulating red blood cell production.

"Whereas at the time of approval safety concerns were theoretical, there is now mounting evidence of documented effects on survival, tumor progression, and thrombotic events which require a re-assessment of the net benefits of this class of drugs," FDA officials stated. "Based on data provided to FDA, there is no evidence that ESAs improve quality of life or cancer outcomes."

Although Thursday's meeting is only the latest in a long string of FDA actions concerning the potential dangers of these drugs since their approval in the early 1990s, the panel will be considering the possibility of completely withdrawing approval of these medications for use in cancer patients. The panel will also look at less drastic options that include less severe restrictions for patients with certain cancers or no hope of a cure and a plan that would require cancer patients to sign consent forms before starting the anemia treatments.

This isn't the only group of patients using ESAs that concerns the FDA. In kidney patients, past research has found that if these drugs are used to raise hemoglobin levels above 12 grams per deciliter of blood, the risk of death increases.

The growing body of
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