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FDA Adds Stern New Warnings to Popular Anemia Drugs

Procrit, Epogen, Aranesp Can Cause Heart Attacks, Strokes, Blood Clots

March 10, 2007
The Food and Drug Administration (FDA) is warning doctors to be more careful when they prescribe certain widely used anemia drugs. The agency said the drugs -- sold under the names Procrit, Epogen and Aranesp -- can increase the risk of death and other serious problems in patients with cancer and kidney disease.

The drugs are genetically engineered versions of a natural protein, erythropoietin, that increases the number of red blood cells. They are huge sellers, with combined 2006 U.S. sales of $10 billion, according to industry sources.

The drugs, known as ESAs, are commonly prescribed for patients with kidney disease and chemotherapy patients, since both conditions tend to cause anemia.

The FDA said that recently completed studies found an increased risk of death, blood clots, strokes, and heart attacks in patients with chronic kidney failure when the drugs were given at higher than recommended doses. In other studies, more rapid tumor growth occurred in patients with head and neck cancer who received these higher doses.

In studies where ESAs were given at recommended doses, an increased risk of death was reported in patients with cancer who were not receiving chemotherapy and an increased risk of blood clots was observed in patients following orthopedic surgery.

"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," said Steven Galson, MD, MPH, director of FDA's Center for Drug Evaluation and Research.

"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 (ODAC) meets in May and further revisions to the labeling may occur after that meeting," he said.

Safety concerns from earlier ESA studies were discussed during a 2004 meeting of the committee. Product labeling was previously revised in 1997, 2004, and 2005 to reflect new safety information.

All three drugs are manufactured by Amgen Inc. of Thousand Oaks, California. Procrit is marketed and distributed by Ortho Biotech LP, a subsidiary of Johnson & Johnson.

The FDA's new "black box" warnings urge that:

• doctors monitor patients' levels of red blood cells and use the lowest possible dose to avoid the need for blood transfusions.

• doctors and patients carefully weigh the risks of using anemia drugs vs. the risk of a transfusion if anemia gets too bad.

The companies said they would cooperate.

"Amgen is committed to providing timely and appropriate communications to physicians and patients whenever we become aware of new safety information that could affect clinical practice," the company said in a statement.

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