Aranesp, Epogen and Procrit Health Risks to be Reviewed Further by FDA

The FDA indicates that it will further examine the side effects of anemia drugs, including Aranesp, Epogen and Procrit, due to the potential increased risk of heart attacks, strokes and blood clots.

In an editorial in the New England Journal of Medicine, Ellis F. Unger, deputy director for clinical science at the FDA Center for Drug Evaluation and Research, said that it is time to re-evaluate the use of erythropoiesis-stimulating agents (ESAs), which are used to treat anemia in patients with kidney disease. The review comes after studies in recent months not only confirmed some Aranesp, Procrit and Epogen health risks, but also suggested that the drugs provide little health benefit.

Unger wrote that an FDA advisory committee will review use of the ESAs sometime later this year, but did not provide a date for a committee meeting. In his editorial, Unger said that recent studies tried to show that Aranesp, Epogen and Procrit could reduce the need for blood transfusions by raising hemoglobin concentrations and improving the clinical outcome for kidney disease patients. “Unfortunately and unexpected, all results have suggested the opposite,” Unger wrote.

Aranesp (darbepoetin alfa), Epogen (Epoetin alfa) and Procrit (Epoetin alfa) are prescribed to patients with kidney disease, anemia, HIV and cancer to stimulate bones to increase the production of red blood cells. They are also prescribed to patients preparing to undergo major non-heart surgery to reduce the number of transfusions such patients must receive. Amgen manufactures all three drugs, though Procrit is sold and marketed by Johnson and Johnson.

In 2008, Aranesp sales were $3.1 billion, and Procrit accounted for $2.46 billion in sales. Researchers estimate that by 2002, the drugs were being prescribed to nearly half of all cancer patients.

A number of studies have suggested that the drugs may increase the risks of heart attack, strokes, blood clots and death, causing sales to drop in recent years. In 2007, the FDA issued a public health advisory regarding the drugs, saying that side effects of the Anemia drugs could increase the risk of injury or death at high doses. The FDA required that the drugs add a “black box warning” alerting patients to the risk of blood clots, strokes, heart attacks and death. The black box warning is the strongest label warning the FDA can require of a medication.

Two studies released this fall raised even more questions about the drugs’ safety and effectiveness. One study, presented at the annual meeting of the American Society of Nephrology in San Diego, concluded that the use of Aranesp increased the risk of stroke and did not reduce the risk of either death or cardiovascular events among diabetes patients with chronic kidney problems and anemia.

Another study conducted by New York-Presbyterian Hospital and Columbia University Medical Center found that ESAs doubled the risk of blood clots by patients using the drugs and have resulted in no detectable decrease in the rate of blood transfusions among cancer patients.

“The alarming rates of serious cardiovascular events in the trials…suggest that even small reductions in the relative risk could translate into substantial reductions in cardiovascular-related morbidity and mortality,” Unger said in his editorial.