FDA Issues New Warnings for Anemia Drugs

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"In the current label revisions, we have endeavored to include as much information as possible so physicians and their patients can make informed treatment decisions," he added.

For cancer patients, the new warnings emphasize that the drugs can cause tumor growth and reduce survival among patients with advanced breast, head and neck, lymphoid and non-small cell lung tumors. This is especially true when the dose is designed to produce a hemoglobin level of 12 grams per deciliter of blood or more.

For hemoglobin levels less than 12 grams per deciliter, the label will say there is no evidence to determine if the drugs cause any of these problems, the FDA said.

"We recommend that prescribers talk to their patients about the risks that ESAs might cause cancer to grow or shorten survival before they prescribe these drugs or continue ESA therapy, Pazdur said. "The risks should be weighed against blood transfusions and their associated risks."

The new label will also make it clear that ESAs should be used in cancer patients only when their anemia is caused by chemotherapy and not from other causes. Also, ESAs should be stopped when the patient's chemotherapy has ended, the FDA said.

For patients with chronic kidney failure, the new black box warning says that ESAs should be used to keep hemoglobin levels between 10 grams per deciliter to 12 grams per deciliter. Higher hemoglobin levels in these patients can increase the risk for death, stroke, heart attack or heart failure, the FDA said.

The new labeling also gives instructions for dosage adjustments and hemoglobin monitoring for chronic kidney failure patients who do not respond to ESA treatment.

The new label also says there is no evidence that ESAs improve symptoms of anemia, quality of life, fatigue, or patient well-being in cancer patients or patients with HIV taking the drug AZT.

"There are no data from controlled trials demonstrating that ESAs improve symptoms of anemia, quality of life, fatigue or patient well-being," Pazdur said.