Originally published August 13 2008
A Thousand Patients Killed Each Month by Cardiac Bypass Anti-Bleeding Drug
by David Gutierrez, staff writer
(NaturalNews) The FDA's delay in taking Trasylol off the market led to 1,000 deaths each month for a year and a half, according to the doctor who first alerted the agency to the dangers of the drug.
"Between my study and November 5, [2007] when it was taken off the market, there were approximately 431,000 patients who received the drug," said Dr. Dennis Mangano. "As I calculated, 22,000 lives could have been saved. It's about a 1,000 lives saved per month delay in taking that drug off the market."
Trasylol, made by Bayer, was approved by the FDA in 1993 as a drug to prevent bleeding in high-risk surgical patients. In 1998, this approval was extended to cover all heart bypass surgery patients. Due to aggressive marketing, the drug became a major moneymaker for Bayer, with sales of $300 million by 2005 and sales of $750 million projected for 2006.
Then in 2006, Mangano and colleagues found that patients being given Trasylol suffered significantly more kidney failure and death than patients being given alternate anti-bleeding drugs, or even those being given no drugs at all. Mangano alerted the FDA, which issued a warning to doctors and scheduled a meeting about the drug for eight months later.
The FDA decided to keep the drug on the market. Then Harvard researcher Alexander Walker told the agency that at Bayer's behest, he had conducted a study similar to Mangano's, with similar results. The company had never revealed those results to the FDA.
The agency responded by issuing another warning and scheduling a meeting about the drug for one year later.
In 2007, a large Canadian trial of the drug had to be halted early because so many patients were dying. Germany immediately banned Trasylol, while Canada and the FDA asked Bayer to voluntarily remove it from the market. Bayer complied.
To date, surgeons in the United States are still allowed to use Trasylol in special cases.
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