February 21, 2008
More Dangers Revealed in Discontinued Drug
New research has sparked more reaction over the dangerous anti-bleeding drug Trasylol.
Two U.S. studies were conducted after Bayer, the drug's manufacturer, discontinued the product last fall. Bayer, the drug's manufacturer funded one of the two new U.S. studies, and said in a statement this week that both of them were flawed, while Dr. Sidney Wolfe of Public Citizen's Health Research Group disagrees.
"I just don't know how much further evidence you need," he said.
After 14 years of being on the market, Bayer decided to discontinue Trasylol when a Canadian study was disrupted by the deaths of patients who were taking Trasylol.
In one study, researchers at Duke University Medical Center studied over 10,000 patients who had bypass surgeries between the years 1996 and 2005. They found that 6.4 percent of patients taking Trasylol died within 30 days of the surgery and within one year of surgery, almost 16 percent had died "“ both figures at a rate of two-and-a-half times more than patients who were given a different drug or received no treatment.
A second, broader study was funded by Bayer. It looked at about 78,000 patients in the U.S. from 2003 to 2006. The results found that the risk of death after surgery was 64 percent higher in the Trasylol group than in patients taking a different drug. Dr. Sebastian Schneeweiss of Harvard Medical School, the study's lead author, says Bayer was aware of these figures before entering an FDA meeting to discuss the drug.
At the time of the FDA meeting, Bayer chose not to discuss the national study because they said the results were preliminary. The panel found that about 2,000 patients a year had died from taking the drug, but after scientists said weren't ready to conclude that the drug was the cause of death, the FDA panel voted to keep the drug on the market.
Trasylol was approved by the FDA in 1993 for its use in heart bypass surgeries.
Results from the halted Canadian study were never released after the FDA chose to stop production of Trasylol last year.
Dr Wolfe said he thinks that the FDA should prosecute Bayer for withholding information in 2006, while Bayer officials insisted that the drug's benefits outweigh its risks.
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