Trasylol Injury Attorneys
Serving Oklahoma City, Oklahoma and surrounding areas
Trasylol (aprotonin), a clotting drug used to stem bleeding during open heart surgery, and given to millions of heart bypass patients in the United States, has been linked to an elevated risk of kidney failure leading to death. Trasylol was withdrawn at the request of the FDA in November, 2007, but the link between the drug and fatalities was first published in January, 2006.
Trasylol was approved by the FDA in 1993 to control bleeding during heart surgery and to minimize the need for blood transfusions. It works by blocking enzymes that dissolve blood clots. In 2006, Dr. Dennis Mangano published a study in the New England Journal of Medicine that showed the drug doubled the risk of kidney failure, and tripled the risk of stroke. He found that the five-year death rate for patients who received Trasylol was 20.8%. Those who received another drug, aminocaproic acid, had a death rate of 15.8%, and those who were given tranexamic acid had a death rate of 14.7%.
Trasylol’s worldwide sales reached $210 million in 2005, and the Associated Press reported Bayer’s Chief Executive, Werner Wenning, believed sales would reach $600 million in 2006. However, shares of the company fell more than 3% when Dr. Mangano’s study came out.
In response to Dr. Mangano’s article, Bayer AG, the maker of Trasylol, commissioned a study of its own, led by Harvard professor Alexander Walker. Looking over the records of 70,000 patients who were given Trasylol, Prof. Walker backed the claims made by Dr. Mangano. Bayer suppressed these findings when they met with the FDA in September. When Prof. Walker found his study was suppressed, and that the FDA had reapproved the drug, he went public.
On a 60 Minutes segment about this story, which aired February 24, 2008, Dr. Mangano claimed that if Trasylol was removed from the market when his study was published, 22,000 lives could have been saved. After the story aired on 60 Minutes, Bayer issued a statement on its website stressing its continued support for “a favorable risk-benefit profile for Trasylol when used according to labeling.” The company also stated that Trasylol’s suspension is only temporary.
If you or a loved one has taken Trasylol and suffered kidney damage, heart failure or a stroke, you could have a Trasylol side effects claim. Please contact Stipe Injury Law in Oklahoma City, Oklahoma today.
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