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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' manufacturers add a "black box" warning to the medications last November. The warning indicates that the medications should be used at the lowest possible doses to avoid risks such as blood clots, heart attacks, stroke, congestive heart failure, increased tumor growth and an increased risk of death. The FDA also noted the trials generally indicated an increased risk when blood levels were raised above 12 grams per deciliter.

"This new information further underscores the safety concerns regarding the use of ESAs in patients with cancer, which [the] FDA addressed in previous communications," Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research, said in a statement last November.

Just last week, Amgen agreed to expand the "black box" warning on all three drugs to include information about tumor growth and death in patients with early-stage breast cancer and cervical cancer. Johnson & Johnson markets Procrit in an agreement with Amgen, the Wall Street Journal reported.

When Procrit was first approved in 1989, the drug was touted as a treatment to lessen fatigue and improve quality of life among cancer and HIV patients with anemia, but the revised label states there was no evidence to back that claim. The label change was the fifth such change since Procrit's approval, FDA officials said.

In statements released this week, both companies defended the safety of their drugs, when used according to recommended dosages, for the treatment of chemotherapy-induced anemia. However, FDA documents noted there is no evidence to suggest lower doses are any safer.

More information

For more on ESAs, go to the U.S. Food and Drug Administration.



SOURCES: March 11, 2008, briefing documents, U.S. Food and Drug Administration; March 12, 2008, statement, Johnson&Johnson; March 13, 2008, Wall Street Journal


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