The FDA has ordered that “black box” warnings be placed on the labels of Amgen Inc’s Aranesp and other anemia drugs to note the drugs have been shown to impair survival in certain cancer patients. The strongest-possible warning states the drugs shortened overall survival, or caused more rapid tumor growth, in clinical studies in patients with breast, non-small cell lung, head and neck, lymphoid and cervical cancers, when given at high doses. The so-called erythropoiesis-stimulating agents (ESAs) are approved to treat anemia in patients with chronic kidney failure and in cancer patients undergoing chemotherapy.

About a year ago, the FDA first required a warning to the labels of Aranesp, as well as Amgen’s Epogen and Johnson & Johnson’s Procrit. This came after studies showed an increased risk of death for some patients. Over the past year, there has been a great deal of negative news about the drugs, which are genetically-engineered versions of a protein that boosts production of oxygen-carrying red blood cells. Sales of Aranesp, Amgen’s top-selling product, fell 12% last year to $3.6 billion, while sales of Procrit, which is less important to J&J’s bottom line, fell 9.4% to $2.9 billion.

In a related matter, federal advisers said anemia drugs sold by Amgen Inc. and Johnson & Johnson should be sharply restricted to a segment of cancer patients – a recommendation that could cost the companies millions of dollars. The limits, proposed on March 13th by an FDA panel, were the latest blow to the three blockbuster medications already plagued by concerns over increased risks of death and tumor growth. The cancer experts overwhelmingly voted to keep the drugs on the market for chemotherapy patients, but said use should be limited to those with incurable forms of cancer. The experts also voted to withdraw the drug’s use in patients with breast or head-and-neck cancers, such as those affecting the sinuses, throat, and lymph nodes. The FDA often follows its panelists’ advice, although it is not required to do so. It will be interesting to see what the FDA does with the recommendations.

Source: Reuters and Associated Press

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