The Trasylol injury lawyers at Davis & Crump, P.C. are currently investigating instances where heart surgery patients died after being treated with Trasylol. Since the Bayer AG drug was brought to market in 1993, it has been used in a third of all open heart surgeries in the US. However, numerous studies have indicated that Trasylol puts such patients at a higher risk of death. In November 2007, Trasylol was finally removed from the market after a portion of a Canadian clinical trial was halted because Trasylol subjects were dying at a higher rate than others in the study. Our Trasylol injury lawyers have concluded that Bayer attempted to cover up Trasylol’s deadly side effects, allowing many patients to die needlessly. The Trasylol injury lawyers at Davis & Crump, P.C. will work hard to help the families of Trasylol victims receive the compensation they deserve for their tragic losses.

In November 2007, 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 significant”. Following the revelations over the Canadian Trasylol study, Bayer suspended sales of the drug in the US, Canada and Germany. The Trasylol injury lawyers at Davis & Crump believe that this dangerous drug should have been removed from the market long ago, and it is our intention to hold Bayer accountable for the deaths caused by Trasylol.

FDA, Bayer Slow to Act on Trasylol Death Reports

In September 2006, Dr. Dennis Mangano presented a study he authored to the Food & Drug Administration (FDA) which found that Trasylol increased the risk of kidney failure requiring dialysis. His study, published in the Journal of American Medical Association, also found that Trasylol increased the risk of death by about 50% for some patients. Bayer executives attended Mangano’s presentation in order to defend Trasylol, and the defective drug was allowed to remain on the market.

What the Bayer executives did not tell the FDA was that their own Trasylol study, known as the 13 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 omission was an oversight, as the company’s management was not informed of the report until after the safety review. 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.

Following the September 2006 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. However, in November – just a few months after the decision – the FDA asked Bayer to suspend Trasylol sales after learning of the Canadian study had been halted.

Even after Trasylol sales were halted, other studies continued to show that the drug put patients at a needlessly high risk of death. A Trasylol study released in February 2008 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 thirty (30) days of the surgery, a rate nearly 2 ½ 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 2 ½ times higher than the other two patient groups.

The lawyers at the law firm of Davis & Crump believe that the vast majority of the deaths were avoidable. Dr. Mangano, the author of the 2006 Trasylol study ignored by the FDA, agrees. In February of 2008, Dr. 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,” said Mangano. “As I calculated, 22,000 lives could have been saved. It’s about 1,000 lives per month.” More Trasylol Studies – One Previously Withheld by Bayer – Confirm Death Risks

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 and 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 were 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 were 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% 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 2 ½ 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 2 ½ times higher than the other two patient groups.

A spokesperson for the consumer advocacy group, Public Citizen, told the Associated Press that the latest Trasylol 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 the federal health officials should pursue criminal charges against Bayer for withholding information from its own study from the FDA panel in 2006.

Contact Us
Davis & Crump is now handling claims for individuals who have suffered renal failure or death after administration of Trasylol. Davis & Crump is experienced in pharmaceutical product liability cases and settlements. If you or a loved one has suffered renal failure or death after being administered Trasylol, contact us at 1-800-277-0300 or send us an email at info@daviscrump.com.