Quoted from http://www.nytimes.com/2010/01/07/business/07fda.html
F.D.A. Plans Safety Check of 3 Drugs for Anemia
- By ANDREW POLLACK
- Published: January 6, 2010
The Food and Drug Administration said Wednesday that it would review of the safety of the widely used anemia drugs sold by Amgen and Johnson & Johnson after another clinical trial suggested that high doses of one of the drugs might cause strokes.
In a commentary published online Wednesday by The New England Journal of Medicine, agency officials wrote that 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.
The officials said the agency would convene an outside advisory committee to re-evaluate the use of the drugs in patients with kidney disease and to consider new ways to control doses of the products.
Amgen, a large biotechnology company, was built on the sales of its anemia drugs, Epogen and Aranesp. Johnson & Johnson sells Procrit, which is manufactured by Amgen. The drugs raise the body’s level of red blood cells, which ferry oxygen to the body’s tissues.
But sales have been falling since 2007, when studies renewed concerns that the drugs might cause heart attacks and strokes and also might worsen the condition of patients with cancer. The drugs are also used to treat the anemia caused by chemotherapy.
Since 2007, the F.D.A. has held three advisory panel meetings on these drugs and has changed the labels of the drugs to warn of risks and lower the doses used.
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