FDA Strengthens Warnings On Amgen, J&J Anemia Drugs

Law360, New York (June 24, 2011, 7:55 PM EDT) -- The U.S. Food and Drug Administration on Friday recommended stricter dosing guidelines for three Amgen Inc. and Johnson & Johnson anemia drugs, warning that they could increase the risk of stroke, thrombosis and death in patients with kidney disease.

The FDA is adding the warnings to the boxed warning section and other areas of the package insert for the erythropoiesis-stimulating agents, which are approved to treat anemia caused by chronic kidney disease, chemotherapy and other conditions.

New warnings for the drugs, which J&J unit Janssen Products...
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