• Common Defective Drugs

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Under pressure from the Food and Drug Administration (FDA), manufacturers of anemia drugs implemented new, sterner black box warnings on bottle labels. The updated labels include a notice warning doctors to monitor patients' hemoglobin levels.

The drugs, commonly used to treat patients on chemotherapy and kidney transplant patients, are Erythropoiesis-Stimulating Agents (ESAs). They include darbepoetin alfa (Aranesp), and epoetin alfa (Epogen and Procrit). These drugs are synthesized versions of the human protein erythropoietin. Natural Erythropoietin is produced by the kidney and increases the number of blood cells produced.

Study Findings

Recent studies have found that these drugs increase the risk of death resulting from heart attacks, strokes, and blood clots when they are given in doses larger than recommended.

Other studies have linked the drugs with tumor growth in patients with cancer of the brain or neck.

Even when taken at the recommended dosage, the drugs were linked with an increased risk of blood clots in cancer patients not receiving chemotherapy, and in patients who have had orthopedic surgery.

Patients should discuss the risk of using these drugs and the risks involved with blood transfusions with their doctors.

Labeling had also been changed in 1997, 2004 and 2005 to include more safety information. The labels may also be changed later this year in May.

Steven Galson, Director of the FDA's Center for Drug Evaluation and research, said, “The agency is in the process of re-evaluating the safety of Aranesp, Epogen, and Procrit on the basis of the results of recent clinical studies. The new studies provide significant new information for both prescribers and patients, and the new information applies to all ESAs, which share the same mechanism of action. The safety of these products will be discussed when the Oncologic Drugs Advisory Committee meets in May and further revisions to the labeling may occur after that meeting.”

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