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March 14, 2008

Black Box warning to be added to anemia drugs

The Food and Drug Administration announced it has approved a Black Box warning to anemia drugs because of increased risk of death and tumor growth. The Black Box warning, which is the most extreme warning, will be added to Aranesp, Epogen, and Procrit. The drugs treat the blood-disorder in patients with kidney failure or who are undergoing chemotherapy. In November last year prior labeling was added to the drugs warning of similar risks in other types of cancers. Labeling approved by FDA said risks occurred when doctors treated patients with elevated levels of the drugs, which stimulate red blood cell levels. The announcement comes less than a week before government advisers are slated to meet to review the risks of the medications. Wall Street analysts expect sales to fall in 2008. The panel may recommend halting the use of the drugs for cancer patients.

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