Trasylol Kidney and Heart Failure Lawsuits
Since the FDA approved Trasylol in 1993, it has been used to prevent blood loss and lessen the use of transfusion in one third of all heart surgeries. In November 2007, Bayer pulled it from the market after several clinical trials showed it was causing kidney disease and patients to die at a higher rate than other patients.
If you or a loved one has suffered a Trasylol injury, contact a Trasylol lawyer to discuss your right to reimbursement for your harms and losses. For a FREE confidential evaluation of your Trasylol claim, call 855-552-2337.
Trasylol (Aprotonin) is the small protein bovine pancreatic trypsin inhibitor (BPTI) that is administered by injection to reduce bleeding during major surgery. Its purpose is to decrease the use of blood transfusions during surgery since its main effect is the slowing down of fibrinolysis, the process that leads to the breakdown of blood clots. In cardiac surgery with a high risk of significant blood loss, aprotinin was shown to significantly reduce bleeding, mortality and hospital stay.
Aprotonin, previously marketed by pharmaceutical company Bayer under the brand name Trasylol, was originally developed in the 1930’s to treat acute pancreatitis. In the 1960’s, its use in major surgery became common. More specifically, Trasylol has been used during coronary artery bypass grafting (CABG). In a study performed in 2004, the use of transfusions decreased by 39% in CABG surgery when Trasylol was administered.
It was reported that sales of Trasylol were $292 million in 2005 alone.
Trasylol FDA Warnings
Although Trasylol reduced bleeding during CABG surgery and minimized the amount of blood transfusions during surgery, patients began experiencing severe side effects. Severe allergic reactions, including rash, hives, and difficulty breathing, as well as kidney failure and heart attack leading to death were being reported as early as 2004.
Before Bayer officially removed Trasylol from the market in 2007, the FDA had been put on notice that use of the drug increased risk of kidney failure and death. In September 2006, Dr. Dennis Mangano published a study he authored on Trasylol in the Journal of the American Medical Association that showed higher incidents of dialysis due to kidney failure as well as a 50 percent higher risk of death. The study was directed to the FDA. However, Bayer was able to defend the drug and Trasylol remained on the market until subsequent clinical trials resulted in many patient deaths.
While Bayer was busy defending Trasylol, it failed to disclose to the FDA that their own trials corroborated Dr. Mangano’s findings. After studying over 78,000 patients, Bayer found the risk of death after surgery to be 64 percent higher in those who were treated with Trasylol compared to other similar drugs.
After the study was published in 2006, the FDA updated Trasylol’s label to include a warning of increased kidney failure and death. The warning also stated Trasylol should only be used in patients who were at risk for significant blood loss during heart surgery.
Does Trasylol Cause Kidney Failure and Death?
Although Trasylol was pulled from the market in 2007, subsequent studies continued to show a high risk of death in patients who received the drug. A study of Trasylol at Duke University Medical Center showed that from 1996 – 2005, close to 16 percent of Trasylol recipients had died at one year after surgery.
If you or a loved one has suffered from any of the following Trasylol injuries, you may be entitled to compensation:
- Severe or fatal allergic reactions – rash, hives, itching, difficulty breathing, tightness in the chest, swelling of the mouth, face, lips, or tongue, fast heartbeat, pale skin, severe low blood pressure, loss of consciousness possibly leading to a lack of heartbeat or breathing.
- Renal dysfunction – also known as kidney failure; can include postoperative kidney dialysis.
- Blood clot
- Low blood pressure
- Heart failure
- Heart attack
This is not intended to be a complete list of Trasylol side effects, and you should immediately contact your doctor if you are having any other problems.
What Should I Do If I Was Given Trasylol During Heart Surgery?
If you or a loved one has experienced a Trasylol injury, you have the right to file a lawsuit against the drug manufacturer – Bayer. Thousands of Trasylol lawsuits have been filed and hundreds have already been settled.
Our St. Louis Trasylol lawyers are currently evaluating cases across the entire United States. Hiring a Trasylol kidney disease and heart attack lawyer costs you absolutely nothing. If our lawyers find you have a valid Trasylol case, we take it on a percentage contingency basis. If you do not win your Trasylol lawsuit, we do not get paid or take a fee.
Trasylol Kidney and Heart Failure Lawyer
As of August 2010, Bayer had settled about 200 cases in which plaintiffs alleged that the use of Trasylol during their heart surgeries caused them to experience injuries such as kidney failure and fatal heart problems.
Bloomberg reported that Bayer had agreed to settle 150 of the cases for $60 million. Thousands of lawsuits are still pending.
Although Trasylol was taken off the US market in 2007, its use in hospitals was phased out through 2008. Patients treated with the drug are still experiencing serious side effects. Studies continue to be conducted; yet Bayer sold its rights to Trasylol to another drug company, The Nordic Group, in 2012. The Nordic Group plans to put Trasylol back on the market in the very near future. Drug companies will stop at nothing to make money off of sick individuals, even when studies indicate this drug is causing the deaths of thousands of people.
If you or a loved one were given Trasylol and suffered kidney or heart disease or other side effects, contact a St. Louis Trasylol lawyer to discuss your case at 855-552-2337. We are help to help Trasylol users across all 50 states. All consultations are free and there is no fee unless we win. Call 24 hours a day, 7 days a week to discuss your case with Top 100 Trial Lawyer.