Use of Anemia Drugs for Kidney Failure Supported by FDA Panel

Despite a potential risk of stroke associated with the use of Aranesp, Procrit and Epogen, an FDA advisory panel has indicated that the anemia drugs are safe to use to treat early stages of kidney failure.

An independent panel of experts voted 15 to 1 on Monday to recommend that the FDA maintain approval for the drugs to be used as chronic kidney disease treatments. The vote comes in spite of a recent study that found that Aranesp, Procrit and Epogen could raise the risk of cardiovascular problems and death in some patients with kidney disease.

The FDA was seeking the panel’s advice on whether stronger warnings or additional restrictions were needed for the anemia drugs in the wake of the study, which was published in September in the New England Medical Journal and other previous studies which suggested an increased risk of stroke. The FDA usually follows the recommendations of their advisory committees, but it is not required to do so.

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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 prior 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.

In February, the FDA announced that it was restricting the prescription of the anemia drugs under a 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.  Cancer patients using the drugs are of special concern, because some studies indicate that ESAs can stimulate tumor growth. Amgen is required to oversee hospitals and doctors using the drugs as part of a cancer treatment program to ensure they are compliant with all aspects of the REMS.


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