Trasylol for Surgery
Trasylol is the brand name used by Bayer to sell the drug Aprotinin. Also known as bovine pancreatic trypsin inhibitor or BPTI, Trasylol is a protein that is used in medication to reduce bleeding during a complicated surgery. It works by slowing down the process fibrinolysis, which leads to the breakdown of blood clots. Trasylol is used to keep down the number of blood transfusions need while also decrease end-organ damage due to low blood pressure that can result due to major blood loss. Initial studies showed that in the case of cardiac surgery that might cause a great loss of blood, Trasylol significantly reduced the bleeding.
However, during the fourteen years it was on the market, there was controversy surrounding the use of Trasylol. In September 2006, the Food and Drug Administration (FDA) found the Bayer did not reveal during testimony that one of their studies showed the use of Trasylol carried great risks. The study showed that the use of Trasylol could increase the risk of death due to heart attack, strokes, kidney or renal failure and encephalopathy. The FDA was tipped off to these findings by one of the study researchers. On October 3, 2006, the FDA issued a statement of concern and asked physicians consider limiting use of Trasylol, especially in cases where the associated risks would outweigh any benefits.
On October 25, 2006, the FDA said that the use of Trasylol may increase the risk of death and on October 29, 2006, the FDA issued a warning that Trasylol may have serious kidney or cardiovascular toxicity. Bayer reported to the FDA that additional studies showed that using Trasylol might increase the chances of death, serious kidney damage, congestive heart failure, and strokes. On November 5, 2007, Bayer decided to withdraw Trasylol from the market after a Canadian study showed that the use increased the risk of death during heart surgery. Studies published in early 2008 showed that the increased risk of death could be between 32% and 64% higher.
On February 17, 2008, “60 Minutes” aired an episode that showed that as far back as the early 1980s, there were concerns about the use of Trasylol. Dr. Nicholas Kouchoukos, a top heart surgeon, conducted his own study of 20 patients given Trasylol and found that of those, 13 patients experienced problems with their kidney function after being give the medication. It is believed that as many as 22,000 deaths may have occurred due to the use of Trasylol.
Approximately 4.5 million people worldwide were given Trasylol during the fourteen years the drug was on the market, with a third of those patients residing in the United States. The widow of open-heart surgery patient Joseph Randone filed suit against Bayer after her husband died from the effects of Trasylol only eight months after his surgery. It was after this first lawsuit that Bayer finally decided to pull Trasylol off the market. Since then, there have been many more lawsuits filed by people who have lost loved ones due to the use of Trasylol and also by people who survived being given Trasylol, but have suffered kidney or renal failure or had a heart attack or stroke.
If you have undergone heart surgery and were given Trasylol then later developed kidney or renal failure and now require dialysis treatment or suffered from a heart attack or stroke, you should contact a lawyer to see if you have a suit against Bayer. If a loved one passed away after being given Trasylol before heart surgery, you may want to talk to a lawyer about the specifics to see if you have a case against Bayer.