Trasylol is commonly used to control bleeding in heart surgeries. It was approved by the FDA in 1993, and is a colorless solution administered through an IV during heart surgeries. When it first appeared on the market, it included a warning about possible anaphylactic reactions, but declined to note the possible links to renal toxicity.

The lawsuit, filed October 20 by James Foster Mathis, alleges he experienced renal failure after he was administered Trasylol on June 28, 2004, before an aortic valve replacement and coronary artery bypass graft.

“Trasylol was indicated for prophylactic use to reduce perioperative blood loss and the need for blood transfusion in patients undergoing cardiopulmonary bypass surgery,” the suit states. “The effects of Trasylol use in cardiopulmonary bypass surgery involve a reduction in inflammatory response, which translates into a decreased need for allogenic blood transfusions and reduced bleeding.”

Since Trasylol’s approval by the FDA in 1993, 4.3 million patients have been subjected to the potentially lethal drug, Mathis claims. In 2005 alone, Trasylol generated about $293 million in sales, the complaint says.

Mathis says he suffered acute renal failure and permanent injuries as a result of his exposure to Trasylol. Numerous other lawsuits have been filed against Bayer for Trasylol use.

To read the entire article, view the West Virginia Record.

For more information on what you can do if you have been affected by Trasylol, please contact Drug Alert Updates.

A renowned researcher estimated that up to 22,000 patient’s lives could have been saved if the FDA had removed Trasylol back in 2006 when the studies began.

60 Minutes shares an insightful video about Joe Randone and his family’s journey to sue Bayer after Joe’s death. Joe was born with a heart murmur, but went on to lead a normal active life. In January 2006, Joe checked himself into the hospital for a routine heart valve replacement surgery. He was told that his surgery had only a 5 percent risk of complications, and he would be able to leave the hospital 5 days after surgery.

Trasylol was put into Joe’s IV and remained on a steady drip for 4 hours. After the surgery, his family was told that there had been complications, but the doctors failed to go into detail. Shortly thereafter, Joe suffered 2 heart attacks and kidney failure. Randone’s surgeon noted that he suffered from “Aprotinin-induced graft thrombosis”. Aprotinin is the generic name for Trasylol, and thrombosis means blood clotting.
Joe was able to return home after the surgery, only to have multiple other health problems. He became so swollen that he couldn’t even shut his eyes. Joe’s eyes were sewn shut to protect his corneas, his gallbladder had to be removed and his legs had to be amputated due to poor circulation. Over the course of 8 months, Joe underwent 19 surgeries.

To make matters worse, Joe could have been given two different drugs without the consequences. Both drugs were found to be effective in studies conducted, without the adverse side effects. Joe eventually died in August 2006.

I truly feel that Bayer and the FDA are more concerned about profits than about protecting and maintaining the health of their consumers. After reading Joe’s story, I almost felt physically sick thinking about the numerous surgeries that his body had to go through, and all for what? Joe and thousands of other people could be leading perfectly healthy lives now if they had not been given Trasylol during surgery. It completely astounds me to think that a drug can be put on the market before it is proven to be completely safe. Studies are conducted to prove the effectiveness of a drug and are tested on a small group of people. If the drug proves to be effective and safe within the small test group, it will then go on the market. My question is: who is protecting the consumer if it is not the FDA or the manufacturer of the drug? The answer remains to be seen.

I urge you to share this story with loved ones and friends, regardless if they have been directly affected by Trasylol or not. No one should have to suffer through life-threatening health complications after taking this drug. Please contact Drug Alert Updates for more information on Trasylol.

Recent studies have found that Trasylol significantly increases the risk of kidney failure, stroke and heart failure or heart attack by up to 55 percent. A recent study, published in The New England Journal of Medicine in February 2008, reported that Trasylol administered during a coronary-artery bypass grafting (CABG) resulted in a 64% higher risk of death than in a group of patients that were administered a different drug.

Another study found that the use of Trasylol in uncomplicated coronary-artery surgeries had up to 181 percent increase in the incidence of stroke or encephalopathy. Encephalopathy alters brain function/ and or structure. Depending on the type and severity of encephalopathy, common neurological symptoms are progressive loss of memory and cognitive ability, personality changes and progressive loss of consciousness.

To assess these risks more fully, the Food and Drug Administration (FDA) initiated hearings to reassess the drug’s safety and risk factors. The FDA concluded that no changes were necessary on the drug’s official labeling.

Finally, on November 5, 2007, the FDA requested Bayer Pharmaceuticals suspend their marketing of Trasylol. The suspension was requested in the interest of patient safety based on the serious outcomes of the drug. The FDA stated that it could not identify a patient population where the benefits of Trasylol outweighed the risks.

If you or a loved one has suffered sever side effects as a result of using Trasylol, please contact Drug Alert Updates.