From the Toronto Star:
A massive Canadian study that caused a popular heart surgery drug to be pulled from the shelves last November has shown it increased the risk of death by 50 per cent over two rival medications.
Pharmaceutical giant Bayer AG voluntarily removed the anti-bleeding drug aprotinin, the generic name for Trasylol, from circulation when early results from the University of Ottawa-led study began to reveal its relative risks.
"The ... study will change the way heart surgery is done around the world," said Dr. David Mazer, an anesthesiologist at Toronto's St. Michael's Hospital and a co-author of the paper, the final draft of which was published online yesterday by the New England Journal of Medicine.
"As a result of the ... research, patients and their doctors can have that much more confidence going forward," Mazer told a media briefing in Ottawa this week.
"It was a bit of a surprise in seeing this," said Dr. Paul Hebert, a critical care physician at the Ottawa Hospital and a principal study investigator.
"We've ... shown, we think reasonably definitively, that (aprotinin) increases the risk of death as compared to two alternatives." ..more
Showing posts with label Trasylol. Show all posts
Showing posts with label Trasylol. Show all posts
Tuesday, May 20, 2008
Tuesday, February 26, 2008
Bayer's Trasylol Boosts Death, Kidney Risks After Heart Surgery
From Bloomberg:
Bayer AG's Trasylol, a drug whose sales were halted last year, raises the risk of death and kidney damage when used to control bleeding in heart surgery, two studies in the New England Journal of Medicine found.
Trasylol patients were 27 percent more likely to die than those getting a rival drug a decade after open-heart surgery, according to a review of 10,275 consecutive patients at Duke University Medical Center. Another study of 78,199 patients, presented to regulators last year after Bayer initially withheld it, found a 78 percent higher death risk a week after surgery.
Trasylol was approved in the U.S. in 1993 to reduce transfusions and bleeding during open-heart surgery. It became a mainstay of care, generating about $333 million in 2005, until an international study the next year tied it to higher rates of heart attack, stroke, kidney failure and death. Leverkusen, Germany-based Bayer suspended sales in November after a pivotal Canadian trial linked it to higher death rates. ...more
Bayer AG's Trasylol, a drug whose sales were halted last year, raises the risk of death and kidney damage when used to control bleeding in heart surgery, two studies in the New England Journal of Medicine found.
Trasylol patients were 27 percent more likely to die than those getting a rival drug a decade after open-heart surgery, according to a review of 10,275 consecutive patients at Duke University Medical Center. Another study of 78,199 patients, presented to regulators last year after Bayer initially withheld it, found a 78 percent higher death risk a week after surgery.
Trasylol was approved in the U.S. in 1993 to reduce transfusions and bleeding during open-heart surgery. It became a mainstay of care, generating about $333 million in 2005, until an international study the next year tied it to higher rates of heart attack, stroke, kidney failure and death. Leverkusen, Germany-based Bayer suspended sales in November after a pivotal Canadian trial linked it to higher death rates. ...more
Tuesday, February 19, 2008
One Thousand Lives A Month, Researcher Estimates 22,000 Lives Could Have Been Saved Had Trasylol Been Pulled Earlier
From CBS News:
This is the story of a drug that was on the market for 14 years and may have contributed to the deaths of thousands of patients. Trasylol, made by Bayer, is given in the operating room to control bleeding. It was a big money maker.
As correspondent Scott Pelley reports, Bayer marketed Trasylol aggressively until it was used in about one third of all cardiac bypass operations in America.
But then, in 2006, a study showed widespread death associated with Trasylol, and as it turns out there was concern long before that.
How much did Bayer know? And why did it take Bayer and the U.S. Food and Drug Administration nearly two years to take the drug off the market after major studies revealed the danger? Two years - during which it's estimated Trasylol was contributing to the loss of one thousand lives a month. ...more
This is the story of a drug that was on the market for 14 years and may have contributed to the deaths of thousands of patients. Trasylol, made by Bayer, is given in the operating room to control bleeding. It was a big money maker.
As correspondent Scott Pelley reports, Bayer marketed Trasylol aggressively until it was used in about one third of all cardiac bypass operations in America.
But then, in 2006, a study showed widespread death associated with Trasylol, and as it turns out there was concern long before that.
How much did Bayer know? And why did it take Bayer and the U.S. Food and Drug Administration nearly two years to take the drug off the market after major studies revealed the danger? Two years - during which it's estimated Trasylol was contributing to the loss of one thousand lives a month. ...more
Tuesday, November 06, 2007
Bayer Stops Sales of Trasylol Globally
I think this article would be a good one to file in the memory banks. The next time American experts say there is no drug research being done in Canada, here's an example that contradicts that statement.
From the Associated Press:
Bayer AG halted worldwide sales Monday of its anti-bleeding drug Trasylol at the request of U.S. and foreign health officials pending further analysis of a Canadian study that suggests it's linked to a 50 percent higher risk of death than the other drugs in the clinical trial.
The Food and Drug Administration asked the company to stop selling the drug, used to prevent excessive bleeding during heart bypass surgery, until it could receive and review further results from the study. The study comparing the safety and efficacy of the drug with two others was recently halted.
"FDA cannot identify a specific patient population where we believe the benefits of using Trasylol outweighs the risk," said Dr. John Jenkins, director of the agency's Office of New Drugs, during a briefing Monday. ...more
Monday, October 29, 2007
FDA says safety board recommends halt to Canadian-led drug trial
From the Globe and Mail:
The U.S. Food and Drug Administration has revealed that the safety board overseeing a large Canadian-led trial has recommended the trial be stopped because of concerns the drug being tested increases the risk of death.
The FDA statement says that the Data Safety Monitoring Board has recommended no new patients be enrolled in the trial.
The study, which goes by the acronym BART, is led by Ottawa researcher Dr. Paul Hebert.
It was designed to test the drug aprotinin — marketed as Trasylol by Bayer Inc. — against other drugs used to reduce blood loss during heart bypass surgery. ...more
The U.S. Food and Drug Administration has revealed that the safety board overseeing a large Canadian-led trial has recommended the trial be stopped because of concerns the drug being tested increases the risk of death.
The FDA statement says that the Data Safety Monitoring Board has recommended no new patients be enrolled in the trial.
The study, which goes by the acronym BART, is led by Ottawa researcher Dr. Paul Hebert.
It was designed to test the drug aprotinin — marketed as Trasylol by Bayer Inc. — against other drugs used to reduce blood loss during heart bypass surgery. ...more
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