Law360, New York (November 9, 2007, 12:00 AM EST) -- The Food and Drug Administration has toughened its black-box warnings on three Amgen Inc. anemia drugs, warning patients that not only could high doses of the drug increase their risk of death but also that relatively low doses were not necessarily safe either.
The target drugs, erythropoiesis-stimulating agents Aransep, Epogen and Procrit, were first slapped with the black-box warning—the FDA's strongest—in March.
All three drugs are taken by anemic patients with chronic kidney failure as well as cancer patients whose chemotherapy triggered anemia, although the latter...
Anemia Drugs May Not Be Safe At Low Levels: FDA
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