FDA Trasylol Failure Could Have Killed Thousands, Researcher SaysFeb 15, 2008 | Parker Waichman LLP
Trasylol, a defective drug manufactured by Bayer AG, may have killed 22,000 people before it was pulled from the market last year. Trasylol was withdrawn in November at the request of the Food & Drug Administration (FDA) after an observational study linked the medicine to kidney failure requiring dialysis and increased death of those patients. But a researcher who presented a Trasylol study to the FDA in 2006 told the TV program “60 Minutes” that thousands of lives would have been saved if the FDA had acted sooner.
Trasylol is a drug used to prevent bleeding during heart bypass surgery, and before it was removed from the market, about a third of all bypass patients had received Trasylol. 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. 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.”
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.
The chairman of the FDA committee that held that meeting, Dr. William Hiatt, told “60 Minutes” that he would have voted to remove Trasylol from the market if he had known about Bayer’s study. He also took issue with Bayer's failure to disclose it. "I thought it was unusual. I thought it was truly inappropriate,"
But even after learning of the I3 drug report, the FDA allowed Trasylol to remain on the market. 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.
It wasn’t until November 2007, when 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”. While the patients in the Trasylol clinical trial did experience less serious bleeding, there were more deaths due to hemorrhage in the Trasylol group. Following the revelations over the Canadian Trasylol study, Bayer suspended sales of the drug in the US at the FDA’s request.
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.