Class-action suit filed over heart drug

From the Calgary Herald:
A Calgary law firm has launched a class-action suit against pharmaceutical giant Bayer Inc. for its drug Trasylol, alleging it causes kidney failure, stroke and other serious health problems.

Docken and Company said Thursday it filed the action on behalf of patients who received the medication during heart surgery, including Calgarian Bob Zerebecki.

The lawsuit alleges Zerebecki, now 62, suffered a serious stroke just hours after the 2006 surgery where doctors gave him Trasylol, leaving the former calculus and physics teacher unable to work. "It's caused a lot of pain and suffering for a lot of families," said lawyer Andrew Bone. ...more

Lawsuit filed against Bayer over drug risks

From CTV News:
Lawyers have filed a multi-million dollar lawsuit against drug giant Bayer Inc. and related companies because one of its drugs, which was given to patients to inhibit bleeding during cardiac surgery, has been linked to a higher risk of death.

Bayer voluntarily withdrew the drug, known as Trasylol, from the market a year ago after a clinical trial found that patients treated with the drug were 53 per cent more likely to die than those treated with older, less expensive anti-bleeding medications.

That study, known as the BART trial, was stopped early and Trasylol was pulled from the market in several countries, including Canada. However, the drug is still available in Canada to some doctors via special-access programs.

Trasylol was originally approved for patients who were at an increased risk of blood loss and blood transfusion while undergoing heart surgery, particularly cardiopulmonary bypass. It is estimated that 4.3 million patients worldwide were given the drug since it was approved in 1993. ...more

Anti-bleeding drug alternatives less risky, cheaper and nearly as effective: study

From the Canadian Press:
A new analysis of clinical trials of a controversial anti-bleeding drug used in heart surgery says that cheaper, safer alternatives work nearly as well and should be recommended.

The review was rushed to print Tuesday by the Canadian Medical Association Journal in advance of a hearing Wednesday of a panel of experts who have been asked to advise Health Canada on future use of the drug, aprotinin.

"For routine use there is no clear advantage of aprotinin that justifies the apparent increase in mortality and the undoubted increase in cost," said Dr. David Henry, lead author of the review and CEO of the Institute of Clinical Evaluative Sciences in Toronto.

"So that in routine clinical practice, there is not now a role for this drug as an adjunct to cardiac surgery."

Aprotinin - which is sold under the brand name Trasylol - was used to reduce bleeding and minimize the need for blood transfusions during coronary artery bypass surgery. Made by pharmaceutical giant Bayer Inc., the drug was thought to be more effective than older anti-bleeding therapies tranexamic acid and aminocaproic acid.

But a landmark clinical trial comparing aprotinin to the alternatives was stopped in October 2007 when it was found that the rate of deaths among people who were given the drug was higher than that of people who got the older, cheaper drugs. ...more

Heart drug's higher death risk detailed in study

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

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

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

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

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