FDA News

FDA Advisory Committee Recommends New Restrictions For Anemia Medications

(May 15, 2007)-- An FDA advisory committee recommended that the agency place new restrictions on anemia medications manufactured by Amgen and Johnson & Johnson because of safety concerns for cancer patients in chemotherapy, the Los Angeles Times reports. The Oncologic Drugs Advisory Committee voted 15-2 to recommend new restrictions on the use of the drugs -- known collectively as erythropoietin drugs -- in cancer patients and voted 17-0 to recommend new studies on the safety of the treatments. The committee said that the labels of EPO medications should establish a minimum recommended hemoglobin level for cancer patients in chemotherapy who begin to take the treatments.

In addition, the committee recommended that FDA consider other revisions to the labels of EPO medications. The committee said that treatment with EPO medications should end when chemotherapy ends to allow physicians time to determine whether treatment with the medications needs to continue. The committee voted 12-5 to recommend against use of EPO medications in patients with certain forms of cancer until additional safety data is collected. The committee also voted against a decrease in the current recommendation that physicians use EPO medications to target hemoglobin levels at no higher than 12 grams per deciliter of blood.

During a meeting before the votes, FDA medical officer Vinni Juneja told the committee that EPO medications "do not increase survival and may promote tumor growth." Juneja added that no completed or ongoing studies have addressed the safety of EPO medications at recommended doses in cancer patients with anemia caused by chemotherapy . In addition, Richard Pazdur, director of the Office of Oncology Drug Products at FDA, said J&J has aired advertisements for the EPO medication Procrit that indicate the treatment increases energy levels in elderly patients, although the company has provided inadequate data to support such a claim. Pazdur said, "The American public is owed an explanation of why these advertisements were allowed to go on".

Committee Chair Gail Eckhardt, an oncologist at the University of Colorado-Aurora, said, "Many of us are concerned on the committee and have a lot of questions" on the design of studies of EPO medications, limited access to studies conducted by companies that manufacture the treatments and the lack of enforcement against inappropriate ads for the medications (Bloomberg/Boston Globe, 5/11). Silvana Martino, a California oncologist, said, "Yes, we have a burning question. Do these things kill people?" Otis Brawley of Emory University said, "What data do you have to assure me that this is not Miracle-Gro for cancer?". Amgen Vice President Roy Baynes told the committee that the label for the EPO medication Aranesp currently is "very conservative."

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