April 28, 2008 - Bayer's Trayslol Named in 78 Lawsuits
To date, 78 lawsuits have been filed against Bayer AG over the drug Trasylol, which is used to prevent bleeding during open heart surgery. Bayer suspended all sales of the drug in November after a Canadian study found that use of the drug resulted in a higher risk of death to surgery patients.
Since Trayslol's approval in 1993, roughly one-third of all heart surgery patients in the have been treated with the drug.
In December 2006 the FDA required a black box warning—the agency's strictest safety warning—on Trayslol's label advising that the drug posed a high risk of kidney failure and death. The label also cautioned that the use of Trasylol should be reserved only for patients at risk of substantial loss of blood during bypass surgeries.
In September 2007 the FDA also recommended that Trasylol undergo further clinical tests, but did not require that Trasylol be pulled from the market. In November, however, terminated a Trasylol trial—called the BART clinical study—after data indicated that the risk of mortality in the study's patients approached “statistical significance.” Soon after learning of the results of the Canadian trial, Bayer halted sales of the drug in the , , and .
Dr. Dennis Mangano, a Trayslol researcher told “60 Minutes” in an interview earlier this year that studies revealed Trasylol's hazards years before it was actually pulled from the market. Mangano himself had presented a study to the FDA in September 2006, which revealed that Trasylol increased the risk of kidney failure and death. Mangano said in the interview that he believes Trasylol should have been removed from the market in 2006. About 22,000 patients died after being administered Trayslol between the date that the study was published and the date that Bayer pulled the drug from the market, Mangano said.
In fact, Bayer's own study, the I3 drug report, confirmed Mangano's findings. That study indicated that Trasylol may increase the risk of serious kidney damage, congestive heart failure, and strokes. Bayer did not report the study's results to the FDA at a safety review for the drug, however. The company claims that the company's management was not informed of the report until after the safety review.
Bayer defended Trayslol in a letter to “60 Minutes” which claimed that “the available data continue to support a favorable risk-benefit profile for Trasylol when used according to labeling.” Bayer plans to evaluate whether Trasylol can be remarketed after additional research is conducted, according to “60 Minutes.” Bayer has also indicated its intent to “vigorously defend” against the Trasylol lawsuits.