Nearly a Third of Bypass Patients Given Trasylol

Seattle, WAIt has been found that Trasylol was given to as many as one-third of U.S. patients who had undergone heart bypass or comparable surgery before the November 2007 recall of the drug, according to researcher Dr. Dennis Mangano.

Approved by the FDA in 1993, Trasylol is used to reduce bleeding during heart bypass surgery by blocking the enzymes that dissolve the blood clots, but has been a hot topic in the news due to allegations that Trasylol causes kidney damage that has resulted in severe illness and even death. In January 2006, Dr. Mangano had published his study in the New England Journal of Medicine regarding the dangers of Trasylol and has further stated that if the drug had been taken off of the market at the time of his study, approximately 22,000 lives could have been saved.

However, it was the responsibility of the FDA to ensure that the drug be removed amid proof that it caused kidney problems in individuals who had received the drug. However, it wasn't removed until November 2007 when the FDA realized that many of the kidney problems came in the form of kidney failure that required dialysis and that the death of patients increased exponentially.

On Sunday February 17, the news show, "60 Minutes" interviewed Dr. Mangano who stated that the drug's manufacturer, Bayer AG, did not provide the FDA with information regarding its own research on Trasylol that yielded the same results as Mangano's findings. It was much later when Bayer blew the whistle on their own internal research.

Mangano's study studied 3,900 heart patients and their long-term survival after being given Trasylol during their heart surgery. The patients that were studied had undergone their surgeries at 62 medical facilities around the world and what the study found was quite alarming. Mangano found that the five-year death rate was 20.8% for those patients given Trasylol, whereas the death rate for those given another drug was 15.8%. The lowest was 14.7% for the drug tranexamic acid.

After the "60 Minutes" episode aired on Sunday, Bayer issued a statement on their website stating that the Trasylol suspension by the FDA is temporary and that when all the data is presented as a whole, the benefits outweigh the risks when used properly.

The purpose of the "60 Minutes" segment was to profile the liability case filed by Josephine Randone on behalf of her husband, Joseph Randone, who is believed to have passed away as a result of Trasylol being used during his valve replacement surgery in 2006. Their case is just one of approximately 20 cases filed against Bayer in what is considered to be a defective product lawsuit with claims that the company committed fraud and failed to warn the public of the risks associated with the drug.

Joseph Randone's recovery was supposed to take less than a week, but he went into kidney failure and a number of debilitating conditions followed. Such conditions involved low blood pressure, the amputation of his left hand and his legs, a pace maker, dialysis, and the requirement of breathing and feeding tubes. At the end of his life, he told his wife that he couldn't take it anymore.

Since the allegations that the drug causes kidney problems and kidney failure, Bayer AG shares fell more than 3% when news that the drug doubled the risk of kidney failure was released to the public. Being that Trasylol is one of Bayer's big sellers at $1,300 per dose, Bayer AG hopes that Trasylol will get past all of the scrutiny and the drug can once again be available for sale on the market.

By Ginger Gillenwater