FDA Panel Urges Stronger Warnings for Anemia Drugs

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"There has clearly been an issue raised about the efficacy, the effectiveness and safety of these drugs when used to treat anemia from cancer," said Dr. Len Lichtenfeld, deputy chief medical officer at the American Cancer Society, before the panel voted.

Another expert said he thinks the FDA needs to carefully define when and for whom these drugs should be used.

"The FDA needs to provide a strong message and guidelines about under what circumstances, and for what populations, patients need to be treated with these drugs," said Dr. Ajay Singh, clinical chief of the renal division and director of dialysis at Brigham and Women's Hospital in Boston.

"In addition, we need updated and independent guidelines that advise doctors how to use these drugs that support what the FDA is recommending," Singh said.

The drugs include darbepoetin (Aranesp) and epoetin alfa (Epogen and Procrit). They are genetically engineered versions of a natural protein, erythropoietin, that boosts red blood cell counts to combat anemia. Anemia is a common side effect with certain forms of kidney disease, especially for patients undergoing dialysis, and for cancer patients undergoing chemotherapy.

The three drugs are approved to treat anemia in patients with chronic kidney failure and in patients with cancer whose anemia is caused by chemotherapy. Epogen and Procrit are also approved for patients scheduled for major surgery to reduce potential blood transfusions and for the treatment of anemia due to zidovudine therapy in HIV patients, the FDA said.

Lichtenfeld noted that, when used properly, these medications are effective. They are really for patients undergoing chemotherapy or radiation, not for patients who have completed their treatment, he said.

"These drugs are valuable, and they do play a significant role in helping patients during chemotherapy," Lichtenfeld said. "These are drugs that help people get through treatment. These are drugs that help reduce the need for transfusion."

Singh thinks there have been financial incentives that promote the off-label use of these drugs, which, in this case, involves increasing the patient's hemoglobin level above that recommended on the label.