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Anemia Drugs Cause of Stroke?

January 7th, 2010
The New York Times (1/7, B3, Pollack) reports, “The Food and Drug Administration said Wednesday that it would review the safety of…widely used anemia drugs sold by Amgen and Johnson & Johnson after another clinical trial suggested that high doses of one of the drugs,” Aranesp (darbepoetin alfa), “might cause strokes.”
Agency officials published an article in The New England Journal of Medicine that said “the results of the new trial, as well as of previous trials, ‘raise major concerns’ about the use of the drugs to treat the anemia caused by chronic kidney disease.” In a commentary published in The Journal of the American Society of Nephrology, Dr. Ajay K. Singh, of Brigham & Women’s Hospital and Harvard Medical School, said “that avoiding the use of the drugs in kidney patients not undergoing dialysis ‘is now the soundest approach given’” in the recent study.

Bloomberg News (1/7, Waters) reports that the agency “will convene an advisory committee to re-evaluate the use of” Amgen’s Aranesp and Epogen and J&J’s Procrit following studies that showed “high amounts boost the risk of heart attacks, blood clots, and stroke.” Robert Temple, deputy director for clinical science at the FDA’s Center for Drug Evaluation and Research, noted that the trials were intended “to show that using” the drugs “to raise hemoglobin concentration…improves clinical outcomes,” but “all results have suggested the opposite.”

 

 Agency officials said lower doses of the drugs and monitoring blood hemoglobin more frequently may improve clinical outcomes, Dow Jones Newswire (1/7, Dooren) reports. According to a spokeswoman for the FDA, the advisory panel will address target levels for blood hemoglobin. Aranesp and Procrit are also currently approved for anemia in certain cancer patients who undergo chemotherapy. Reuters (1/7) also covered the story.

 

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