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Bayer Receives Final Blow To Recalled Trasylol

Posted by Jane Akre
Thursday, May 15, 2008 10:20 AM EST
Category: Major Medical, Protecting Your Family
Tags: FDA and Prescription Drugs, Heart Attacks, Trasylol, Dangerous Drugs, Drug Products, Wrongful Death, Defective Drugs

Trasylol removed as a Canadian study confirms it leads to more deaths.

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IMAGE SOURCE: ©iStockPhoto/ heart surgery/ miralex 

 

The maker of the recalled drug Trasylol, Bayer AG of Germany, had planned to bring the drug back to the market after the release of a major study. But instead the study is making that less likely.

Last November, Bayer temporarily suspended sales of Trasylol (aprotinin) pending the outcome of a large Canadian clinical trial known as BART.

In October, BART had to be suspended early when data began showing a higher risk of death among patients on Trasylol, given during high-risk heart surgery.  The Ottawa Health Research Institute stopped enrolling patients because of ethical concerns.

Now BART’s results have been compiled and released in Wednesday’s New England Journal of Medicine. 

It too confirms earlier findings that Trasylol led to an increase in the chance of death by 54 percent when compared to the other two drugs more commonly used during heart surgery to cut down on excessive bleeding.

Among patients given Trasylol, six percent died within 30 days compared to patients on the standard and less expensive treatments, tranexamic acid or aminocaproic acid.

Among those who died, the patients with complications including heart attacks after surgery was higher in the Trasylol group when compared to patients on the other two drugs.

The Canadian BART study involved 2,331 patients at 19 cardiac centers.  Researchers conclude that while Trasylol was marginally effective, the risks do not outweigh the benefits.  

Lead author, Paul Hébert, critical-care physician at the Ottawa Hospital in Ottawa, says the drug should not be used for high-risk cardiac surgery patients.

He tells the Wall Street Journal, "This study could have been done by the company five to ten years ago."  He adds that the cost of Trasylol at $1,400 doesn’t compare to $4 for aminocaproic acid.

It’s estimated 200,000 patients were given Trasylol in 2006, the peak year of sales, among them Joseph Randone of Long Island.

His story was featured on a 60 Minutes investigative report.  

In it, a renowned researcher calculates that 22,000 patients could have been saved if the Food and Drug Administration removed the heart surgery drug, Trasylol two years ago, when his study revealed patients on the drug double their risk of kidney failure, heart failure and had a 181 percent increase in the risk of stroke.  

Dr. Dennis Mangano, tells 60 Minutes correspondent Scott Pelley that Bayer, failed to tell the FDA about negative results of its own Trasylol study and that the company’s failure placed the drug’s success before patient well-being.

Mangano tells Pelley, "Good medicine demands that you protect the patient. That’s the issue here and not the drug and not the profit margin," he says.

On November 5, 2007, drug maker Bayer Pharmaceuticals Corporation pulled Trasylol from the international market. But Dr. Mangano's says that was two years after his initial warning during which time Dr Mangano says 1,000 lives a month could have been saved.

So far 83 U.S. lawsuits have been filed against Bayer over Trasylol, the company tells the WSJ.  

On Wednesday, the FDA announced that Bayer has agreed to remove Trasylol stockpiles from the U.S. market including warehouses, hospitals and doctor offices.

The drug can still be used in limited circumstances for patients who cannot withstand any acceptable alternative therapies.  #


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