Black Box Warning Added to Anemia Drugs

Scott Kappes

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Last Friday the FDA added the strictest warning available to three anemia medications. The black box warning warns of an increased risk of death and tumor growth associated with the medications. Amgen's Aranesp and Epogen and Johnson & Johnson's Procrit have been shown to accelerate tumor growth in patients with several different types of cancer. The drugs had been linked to similar risks in November, but the new warnings include increased risks for cervical and breast cancer patients.

The medications are usually used to treat anemia in patients with renal failure or in patients undergoing chemotherapy. This Thursday a panel of outside experts is set to advise the FDA about additional warnings or restrictions that should be placed on the blockbuster medications.

In documents posted to the agency's Web site Tuesday, the FDA said there is " insufficient data" to rule out a risk of death and tumor progression in any cancer other than non-small cell lung cancer when the drugs are used according to doses recommended in the labels.

The FDA noted that currently ongoing studies to evaluate the drugs' impact on cancer patients undergoing chemotherapy, but the results will likely not be available for years.