Bayer AG has been hit with 78 lawsuits over the drug Trasylol. In November, Bayer suspended Trasylol sales after a Canadian study linked it to a higher risk of death.
Trayslol was approved in 1993, and was used to prevent bleeding during open heart surgeries. Since its approval, about a third of all heart surgery patients in the US have been treated with Trasylol. Trayslol was the subject of several Food & Drug Administration (FDA) safety reviews before it was finally pulled from the market last year.
In December 2006, following an advisory panel meeting that September, the FDA updated the Trasylol label to include a black box warning – the agency’s strictest safety notice – 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.
Another FDA advisory panel that met in September 2007 agreed with the assessment that Trasylol had a high risk of causing serious side-effects, and it recommended that Trasylol undergo further clinical testing. However, the FDA panel also voted that Trasylol should stay on the market. Then in November, the Canadian Data Safety Monitoring Board had stopped a Trasylol trial – known as the BART clinical study – after a data analysis indicated that the 30-day mortality risk in the study’s Trasylol patients was nearing “statistical significance”. Following the revelations over the Canadian Trasylol study, Bayer suspended sales of the drug in the US, Canada and Germany.
Earlier this year, Trasylol researcher Dr. Dennis Mangano told the television show “60 Minutes” that studies had indicated Trasylol was dangerous years before it was removed from the market. In September 2006, Dr. Mangano presented a study he authored to the FDA which found that Trasylol increased the risk of kidney failure requiring dialysis, as well as death. Mangano told “60 Minutes” that he believes Trasylol should have been taken off the market when he published his study in 2006. Between the study’s publication and November 2007, when Bayer removed the drug, “There were approximately 431,000 patients who received the drug,” Dr. Mangano said. “As I calculated, 22,000 lives could have been saved. It’s about a 1,000 lives per month.”
Bayer executives attended Mangano’s presentation in order to defend Trasylol. What they did not tell the FDA was that their own Trasylol study, known as the I3 drug report, confirmed Mangano’s findings. That study, which analyzed a database of hospital patients treated with the drug, suggested that Trasylol could also increase the likelihood of serious kidney damage, congestive heart failure and strokes. Bayer claims that this was an oversight, as the company’s management was not informed of the report until after the safety review.
But even after learning of the I3 drug report, the FDA allowed Trasylol to remain on the market. It wasn’t until the BART study that the FDA and Bayer finally moved to protect patients from this dangerous drug. But Bayer still hasn’t given up on Trasylol. According to “60 Minutes”, the company is still defending Trasylol. Bayer sent a letter to “60 Minutes” claiming that “the available data continue to support a favorable risk-benefit profile for Trasylol when used according to labeling.” According to the program, Bayer plans to assess whether Trasylol can be remarketed after further research. Bayer also says it will “vigorously defend” itself against Trasylol lawsuits.
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