Anemia Drugs to Carry Warning

The Food and Drug Administration on Friday issued a health advisory for anemia drugs made by Amgen(AMGN) and Johnson & Johnson(JNJ), warning that certain patients could suffer a greater risk of death, blood clots, strokes and heart attacks if they receive a higher-than-recommended dose.

The FDA's warning affects Amgen's Aranesp and Epogen and J&J's Procrit. Each drug is an erythropoiesis-stimulating agent, or ESA, a genetically engineered version of a natural protein made by the kidney. The protein, erythropoietin, increases the number of red blood cells.

"The agency is in the process of re-evaluating the safety of Aranesp, Epogen and Procrit on the basis of the results of recent clinical studies," said Dr. Steven Galson, director of the FDA's Center for Drug Evaluation and Research. "The new studies provide significant new information for both prescribers and patients, and the new information applies to all ESAs, which share the same mechanism of action."

A panel of outside medical advisers will discuss these drugs in May. "Further revisions to the labeling may occur after that meeting," Galson said. Labels were revised in 1997, 2004 and 2005, the FDA said. The FDA also issued health advisories in November 2006 and last month.

The agency said the companies are placing a "black box" warning on the drugs -- the FDA's strongest alert -- telling doctors to monitor patients' red blood cell levels and to adjust the drug dosage to avoid the need for blood transfusions.