800-845-6913
Tuteur Law Networks | Knowledge is Power.
February 17, 2008
At least one critic of the US Food and Drug Administration (FDA) says the organization acted too slowly when it learned of the dangers of Trasylol. According to Dr. Dennis Mangano, approximately 22,000 lives could have been saved if the FDA had removed Trasylol from the market when it received evidence that the drug was linked to thousands of deaths. The FDA received that information two years ago from Dr. Mangano.
Managno was involved in a study of Trasylol, involving 5,065 patients in 17 countries. His study found a link between kidney failure requiring dialysis and increased death in patients given Trasylol. That study was published in January 2006 and in September 2006, was presented to the FDA at a meeting.
At the same meeting, Bayer officials defended their product, but failed to inform the FDA about their own study, which confirmed the negative findings associated with Trasylol. In fact, Bayer’s own study allegedly also indicated that Trasylol was associated with congestive heart failure and strokes. At least one FDA official has affirmed that, had he known about Bayer’s study, he would have voted to remove the drug from the market. He noted that it was unusual and inappropriate that Bayer would not alert the FDA to the study’s results.
According to Mangano, approximately 431,000 patients received Trasylol between the time his study was published and the time Bayer pulled the drug from the market. He believes that approximately 1,000 lives per month could have been saved if the drug had been pulled more quickly.
Continue reading, ‘Too Many Deaths Caused by Trasylol: 22,000 People.’