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FDA 'May Take' Additional Action On Anemia Drugs

money.cnn.com

The U.S. Food and Drug Administration said Thursday it's reviewing additional information submitted by Amgen Inc. (AMGN) and Johnson & Johnson (JNJ) involving risks associated with the anti-anemia drugs Aranesp, Epogen and Procrit and Procrit and "may take" additional regulatory action.

The agency strengthened warnings on the widely used drugs twice last year and plans to hold another advisory panel meeting in the next few months to discuss the new studies, which the agency said were not included in the most recent label update of the drugs on Nov. 8.

The FDA said the studies "provide further evidence of the risks of anemia drugs" known as erythropoiesis-stimulating agents, or ESAs.

The studies show that patients with breast or advanced cervical cancers who received ESAs to treat anemia caused by chemotherapy died sooner or had more rapid tumor growth than similar patients who didn't receive the anemia drug.

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