Aranesp, Procrit and Epogen Health Risks Call For Lower Doses: FDA

The increased risk of heart problems, strokes and death from Aranesp, Procrit and Epogen has led federal health regulators to urge doctors to be cautious with certain users of the anemia drugs. 

In a drug safety communication issued on June 24, the FDA recommended that doctors scale back the use of Aranesp, Epogen and Procrit, and use as little of the drugs as possible on patients suffering from anemia due to chronic kidney disease, which affects about 20 million Americans. The drugs are all members of a class known as Erythropoiesis-Stimulating Agents (ESAs).

The FDA has determined that the side effects of Aranesp, Epogen and Procrit are linked to an increased risk of heart attack, heart failure, stroke, blood clots and death. The FDA is altering the current black box warning to recommend that doctors treating patients with chronic kidney disease “use the lowest dose of ESA sufficient to reduce the need for red blood cell transfusions.”

The decision comes after a number of studies raised concerns about ESA health risks, but also after an FDA advisory committee meeting last year recommended the agency keep the drugs on the market in spite of those risks.  

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.

As more studies suggested that the drugs carried serious, sometimes deadly side effects, sales dropped in recent years. In 2007, the FDA issued a public health advisory regarding the drugs, saying that 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 cardiovascular health risks. The black box warning is the strongest label warning the FDA can require of a medication.

The drugs are already restricted under an FDA-required risk evaluation and mitigation strategy (REMS). Doctors and hospitals that wish to prescribe the drugs will now have to undergo special training to identify high risk users and negative side effects.