Trasylol, Bayer, the FDA and 22,000 Deaths
Trasylol, also known as aprotinin, has been produced and sold by Bayer for about 14 years. It’s been a very popular drug that was used in more than a third of the heart bypass surgeries in America. Some doctors now believe that this drug may have caused the death of 22,000 patients since the FDA first became aware of its serious health risks. How could the government allow this drug to remain on the market given all of the studies linking it to serious injury and death?
Bayer was told about problems with this drug as far back as the 1980’s. Dr. Juergen Fischer, director of the Institute of Experimental Medicine at the University of Cologne (Bayer’s home town), found severe kidney damage in animals given Trasylol. He told Bayer about the problem, but was surprised when Bayer “…wasn’t interested [in examining] these side effects.” In 1992, another doctor found similar problems in humans. Dr. Nicholas Kouchoukos, from the Missouri Baptist Medical Center, and one of this country’s top heart surgeons, conducted a small study in which Trasylol was given to 20 patients. His conclusions from the study? That Trasylol appeared to cause serious kidney problems --- renal failure --- after surgery. The patients went into surgery for, perhaps, coronary bypass, and developed serious kidney disease shortly thereafter. “[The] kidneys did not function properly after surgery, says Dr. Kouchoukos, of 13 of the 20 patients who were given Trasylol during the operation. He was convinced that it was the drug that caused the problems. Note that this study was not funded by Bayer.
Notwithstanding these problems, the FDA approved the drug for use in 1993.But in January 2006, a study was done that surely should have pushed the FDA and Bayer to suspend the use of this drug. More on this study and the consequences of delay in the next blog.#