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As many as one third of all heart bypass patients in the US were given a drug called Trasylol. This drug has been found to be dangerous and you may be entitled to compensation if you or a family member were administered this drug and experienced adverse effects.

A Bayer AG clotting drug used to stem bleeding during open heart surgery, Trasylol, is in the news again (and the television show “60 Minutes”) amid new allegations that 22,000 patients could have been saved if United States regulators had been quicker to remove the drug from the market. Trasylol was withdrawn in November 2007 at the request of the FDA after a study linked the drug to kidney failure requiring dialysis and increased death of those patients.

Trasylol had been given up to as many as a third of all heart bypass patients in the US at the height of its use over a period of many years. The study’s researcher, Dr. Dennis Mangano, said that if the dangerous drug had been taken off the market when he first published his study in January 2006, over 22,000 lives could have been saved.

On the popular news show, “60 Minutes,” Dr. Mangano said that Bayer AG failed to disclose to the FDA that a German drugmaker conducted its own research on Trasylol and confirmed the same dangers that Mangano found in his own research. Dr. Mangano is the Director of the Ischemia Research and Education Foundation, a California-based non-profit group.

Mangano’s study tracked the long-term survival of almost 3,900 heart patients who underwent coronary artery bypass surgery at 62 medical centers worldwide and found that the five-year death rate for patients given Trasylol was 20.8 percent, compared to 15.8 percent for those given another drug, aminocaproic acid, and 14.7 percent for those given tranexamic acid.

In a company statement on its website the day after “60 Minutes” aired, Bayer stressed that the suspension of Trasylol was temporary. “Bayer believes that the totality of the available data continue to support a favorable risk-benefit profile for Trasylol when used according to labeling,” according to the Bayer statement.

Trasylol is one of Bayer's top selling drugs with worldwide sales of $210 million in 2005, according to Bayer in a January 26, 2006 article by Associated Press. On December 9, 2006, the Associated Press reported that Bayer's Chief Executive, Werner Wenning, predicted that sales for Trasylol in 2006 would reach $600 million. However, on January 26, 2006, Reuters reported that shares in Bayer fell more than 3% "after a study showed that its Trasylol drug doubled the risk of kidney failure."

The FDA approved Trasylol in 1993 to control bleeding in patients during heart surgery and minimize the need for blood transfusions. The drug works by blocking enzymes that dissolve blood clots. Trasylol is indicated for patients undergoing cardiopulmonary bypass (CPB) in the course of coronary artery bypass graft (CABG) surgery. A full dose of Trasylol costs approximately $1,300.

The authors of the study on Trasylol predict that halting the use of this drug could prevent as many as 11,000 cases of kidney failure a year and save more than $1 billion per year in dialysis costs.

If you or a loved one had open heart surgery and then suffered a stroke, heart failure, or severe kidney failure, you could have a Trasylol side effects claim. Please visit the website for Colling Gilbert Wright & Carter in Orlando, Florida today.