Trasylol Gone for GoodMay 15, 2008 | Parker Waichman LLP
Trasylol is being removed from the market for good. Bayer AG had suspended marketing of Trasylol, a drug used to prevent bleeding during heart surgery, in November, after a clinical trial found patients treated with Trasylol were dying at higher rates than others. Now, the results of that trial are in, and the death risk has been confirmed. Yesterday, Bayer notified the Food & Drug Administration (FDA) that it was removing the remaining Trasylol stock from the market.
Trasylol was approved in 1993 and has been used in a third of all heart surgery patients in the US. However, Trasylol has been the subject of concern for years, and its safety has been reviewed several times. Last 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.
Now, an analysis of that Canadian trial is set to be published next week. According to media repots, the study found Trasylol increased chances of death by 54 percent, compared to two much-cheaper drugs. Six percent of the Trasylol patients died within 30 days of surgery, compared with 4 percent who got either Amicar or Cyklokapron, despite a slightly lower percentage of the Trasylol patients suffering from massive bleeding or needing transfusions. The researchers found those who died in the Trasylol group had a much higher proportion of heart complications after surgery, including heart attacks.
The Canadian study is just one of several that have illustrated the deadly consequences of Trasylol, and many health advocates believe it should have been removed from the market years ago. In September 2006, Dr. Dennis 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. Ealier this year, Mangano told “60 Minutes” the 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,” Mangano. “As I calculated, 22,000 lives could have been saved. It’s about a 1,000 lives per month.”
Even Bayer had evidence of Trasylol's death risk, but withheld it for a time. 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.
In December 2006, 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. Then in September 2007, even while agreeing with the assessment that Trasylol had a high risk of causing fatal side-effects, an FDA advisory panel voted that Trasylol should stay on the market.
Bayer faces nearly 80 lawsuits over Trasylol. As late as February, the company had maintained that it would eventually return Trasylol to the market. Yesterday, Bayer changed its tune, and said it was removing Trasylol supplies from all countries where it remained in the supply chain, except where local authorities wanted to keep it in the market for special access programs.