FDA says anemia drugs may increase risk of death

FDA says anemia drugs may increase risk of death
WASHINGTON - The U.S. Food and Drug Administration has recommended stronger warnings on three widely used anemia drugs saying that these medications can have serious health effects and even increase the likelihood of death in patients suffering from cancer and chronic kidney failure.

The drugs in question are Aranesp, Procrit, and Epogen, which are manufactured by Amgen Inc., and Procrit, but sold by Johnson & Johnson.

The FDA said in a public health advisory that these drugs must carry black box warnings and also advised doctors to prescribe the lowest effective dose. These drugs belong to a group called erythropoiesis-stimulating agents (ESAs) and are used to increase red cell counts in cancer patients.

"The FDA reminds physicians that erythropoiesis-stimulating agents are approved for the reduction in red cell transfusion. For oncology patients, these products have not been shown to improve or relieve symptoms of anemia or to improve quality of life," said a statement by Richard Pazdur, director of the office of oncology drug products at FDA.

ESAs are used to tank up red cell counts in order to prevent fatigue. However the FDA said that in renal failure this route was indicated, but not in cancer patients.

Aranesp is undoubtedly Amgen's best-selling drug, making $4.1 billion in sales last year. Amgen officials stressed that doctors already used low doses of the drug.

Meanwhile J&J was confident that Procrit was still useful. "We remain confident in the safety and efficacy of Procrit when used according to its label," said Craig Tendler, a vice president at J&J unit Ortho Biotech.