Researcher: FDA Was Too Slow On Trasylol.Tells 60 Minutes He Estimates 22,000 Lives Could Have Been Saved, cbsnews.com. Feb. 17, 2008. A renowned researcher calculates that 22,000 patients could have been saved if the Food and Drug Administration removed the heart surgery drug Trasylol two years ago, when his study revealed widespread death associated with it. The researcher, Dr. Dennis Mangano, also tells 60 Minutes correspondent Scott Pelley that Bayer, the drug’s maker, failed to tell the FDA about negative results of their own Trasylol study and that the company’s failure placed the drug’s success before patient well-being. [ See ]. See previous related new: No more. Watch FDA video in Read More.

Marketing of Trasylol Suspended.Bayer Pharmaceuticals has suspended the marketing of Trasylol (aprotinin) which is used to reduce perioperative blood loss during cardiac surgery with cardiopulmonary bypass. Preliminary results of a Canadian study indicate that while patients given Trasylol experience fewer serious bleeding events, they may also have a greater risk of death than patients taking either of two other antifibrinolytic drugs.
Sales of Trasylol will be suspended until FDA can conduct a thorough analysis of the study and gain a better understanding of the risks and benefits of the drug. Because there are few treatment options for patients at risk for excessive bleeding during cardiac surgery, FDA is working with Bayer to gradually phase Trasylol out of the marketplace so that it doesn’t cause shortages of other drugs used for this purpose.FDA is also exploring ways that physicians may continue to have access to Trasylol in specific cases where the benefits of the drug outweigh the risks. FDA Patient Safety News: January 2008