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FDA Panel Supports Anemia Drugs for Cancer Patients
Date:3/13/2008

But adds strong caveats on their use for some undergoing chemo

THURSDAY, March 13 (HealthDay News) -- A U.S. Food and Drug Administration advisory panel voted Thursday to recommend continued use of blood-boosting drugs for cancer patients on chemotherapy, with the caveat that certain cancer sufferers should steer clear of the medications.

According to the Wall Street Journal, the panel voted 13-1 for letting Amgen Inc. continue selling Epogen and Aranesp and Johnson & Johnson continue selling Procrit. But the panel voted 11-2 to recommend against the drugs' use for cancer patients who are likely to be cured. And, in a 9-5 vote, the panel also recommended the drugs not be used in patients with breast or head and neck cancer.

FDA briefing documents filed this week before the meeting showed there are eight clinical trials that now suggest these widely used medications 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."

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.

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 evidence led the FDA to have the drugs' manufactur
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