Trasylol use has been linked to KIDNEY DAMAGE, HEART FAILURE, STROKES and DEATH.

Trasylol was used in one third of all open heart surgeries in the United States between 1993 and 2007. But while multiple studies showed that Trasylol was associated with greatly increased risk of death in heart surgery patients, the drug remained on the market.

In 2006, a scientist presented the Food and Drug Administration with a study that found that Trasylol increased the risk of kidney failure requiring dialysis. It also found that Trasylol increased the risk of death by approximately 50 percent for some patients. Executives from the drug's manufacturer, Bayer AG, attended Mangano’s presentation and defended Trasylol; the defective drug was allowed to remain on the market.

But Bayer did not tell the FDA was that their own studies not only confirmed Mangano’s findings, but found that Trasylol could also increase the likelihood of congestive heart failure and strokes—and that the risk of death after surgery was 64 percent higher among patients taking Trasylol. Bayer claimed that this omission was an oversight, and that company management was not informed of these internal findings until after the FDA safety review.

Following the 2006 meeting, the FDA updated the Trasylol label to include a black box warning stating that the drug placed patients at a high risk of kidney failure and death. The black box warning also cautioned that the use of Trasylol should be reserved only for patients who were at risk for significant blood loss during bypass surgeries. But the drug stayed on the market.

As late as September 2007, an FDA advisory panel agreed that Trasylol presented an increased risk of serious side effects, and recommended that the drug undergo further testing. But it stopped short of recommending that Trasylol be pulled from the market.

In November of 2007 the drug was finally removed from the market in the US, Canada and Germany after subjects taking Trasylol in a Canadian clinical study were found to be dying at a higher rate than others in the study.

A study released in early 2008 reviewed more than 10,000 heart bypass patients and found that 6.4 percent of those who had been given Trasylol died within one month—nearly 250 percent the rate of patients who received another drug or no treatment for excessive bleeding. And by one year after surgery, almost 16 percent of Trasylol patients had died — again, nearly 250 percent the rate of the other two patient groups.

Dr. Mangano, the author whose 2006 Trasylol study was ignored by the FDA, told CBS's "60 Minutes" that he believes Trasylol should have been pulled from the market in 2006. “There were approximately 431,000 patients who received the drug" between the time of his report and when Trasylol was finally taken off the shelves, said Mangano. “22,000 lives could have been saved.”