The scales are tipping against Trasylol. Patients given the Bayer anti-bleeding drug were more likely to die, according to two U.S. studies published in the New England Journal of Medicine, raising new questions about its safety. Bayer suspended sales in November after a big Canadian trial linked the drug to higher death rates, but the company says it still believes Trasylol has a "favorable risk-benefit profile" and considers the suspension temporary.
In one of the new studies, which included more than 10,000 patients, those given Trasylol during open-heart surgery were 27 percent more likely to die for a decade afterward. The other study--just published though it was presented to regulators last year--found a 78 percent higher risk of death a week after surgery.
You'll recall that an FDA advisory panel assembled in 2006 specifically to consider Trasylol's possible links to heart attack, stroke, kidney failure, and death. At that meeting, Bayer scientists didn't share data that showed the drug carried increased risk of death. After an internal investigation, Bayer concluded that the data was withheld due to human error.
When Bayer suspended sales of the drug, it had been on the market for 14 years. One of the researchers involved in the new studies said 22,000 people could have been saved had the FDA pulled Trasylol two years ago, after the advisory panel met. "The system is ridiculous," the researcher told the St. Petersburg Times. "It's all pro-industry. Who's protecting the patient?" For its part, however, Bayer says the research--both the data it didn't give the FDA in 2006 and the two newly published studies --is flawed.
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