More Trasylol Studies -- One Previously Withheld by Bayer -- Confirm Death RisksFeb 21, 2008 | Parker Waichman LLP
Two more Trasylol studies have concluded that heart surgery patients are more likely to die if treated with the defective drug. Trasylol, manufactured by Bayer AG, was the subject of several Food & Drug Administration (FDA) safety reviews before it was finally pulled from the market last year. One of the newly released studies was completed prior to a September 2006 FDA advisory panel meeting on Trasylol, but was never submitted by Bayer to the FDA. Bayer suspended sales of Trasylol at the request of the FDA after Canadian health officials halted a portion of a clinical trial after it was determined that patients in the study treated with Trasylol where more likely to die.
Trasylol 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. In December 2006, following the September meeting, 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.
Now two more studies have added to fears that Trasylol is dangerous. Bayer funded one of the two new studies, and had the preliminary results ready before the September 2006 federal hearing on the drug’s safety, but did not present them at the meeting. Bayer has defended its actions by saying the study results at the time where only preliminary and the study itself was flawed. The Bayer study looked at more than 78,000 patients nationwide in a period from January 1, 2003 to March 31, 2006. After adjusting for other factors, the researchers found the risk of death after surgery was 64 percent higher in the Trasylol group than in those taking a comparison drug.
The second Trasylol study looked at more than 10,000 patients who had bypass surgeries at Duke University Medical Center from 1996 through 2005. It found that 6.4 percent of patients who were given Trasylol died within 30 days of the surgery, a rate nearly 2½ times higher than patients who got another drug or who received no treatment for excessive bleeding. At one year after surgery, almost 16 percent of Trasylol patients had died — again, roughly 2½ times higher than the other two patient groups.
A spokesperson for the consumer advocacy group Public Citizen told the Associated Press that the latest Trayslol studies are convincing confirmation of the drug’s dangers. “I just don’t know how much further evidence you need,” said Dr. Sidney Wolfe. Wolfe added that federal health officials should pursue criminal charges against Bayer for withholding information from its own study from the FDA panel in 2006.