FDA To Review EPO Drugs On Sept. 11
Make a commentBy Ed Silverman // July 19th, 2007 // 11:07 am
Two FDA advisory committees - Cardiovascular and Renal Drugs and Drug Safety and Risk Management - will hold a joint meeting on Sept. 11 to review the risks and benefits of those controversial EPO drugs. These include Amgen’s Aranesp and Epogen, and Johnson & Johnson’s Procrit, which are used for anemia in chronic renal failure.
Two months ago, an FDA panel recommended tougher warnings, more safety studies and caution on usage. That followed a March public health advisory, which included the addition of Black Box warnings about the risk of serious side effects with aggressive dosing by docs who, in some cases, reportedly receive inducements by the manufacturers.