St. Louis, MOTrasylol is an injectable drug made by Bayer. It is used to prevent excessive blood loss during heart surgery, mainly for patients undergoing coronary artery bypass grafting (CABG).
Trasylol has been in the news lately - it has now been linked to increased risk of death, kidney or renal failure, heart attacks, strokes and encephalopathy. One explanation is that Trasylol is used to promote clot formation to prevent bleeding, the exact opposite effect of medical treatment for some heart disease, that attempts to dissolve clots and prevent clot formation. Kidney failure may be due to Trasylol being taken up by tubules in the kidneys and interfering with normal kidney function.
Anaheim, CA: My kidneys went into failure immediately after my heart surgery," said Tom Hutchins (not his real name pending a lawsuit). "I have been on dialysis for a year now and I am now diagnosed with chronic kidney disease (CKD). I never had any kidney problems prior to my surgery. My medical records show that I was injected with Trasylol." Tom hasn't worked since his surgery in 2004 and is currently disabled. "I am taking a lot of medication for my heart and kidneys that render me tired just about all the time; I can't do any work and can barely help with the house chores—even my family is suffering because of my illness."
Portland, OR: October of 2005, Christine Tackler's husband had triple bypass surgery at Legacy Emmanuel hospital. "He seemed to be okay when he came out of surgery but his condition just deteriorated," said Christine. "A few days later complications set in and he lost a leg and toe. The doctors said it was due to his bad kidney - one of them wasn't functioning at all. We were in shock - my husband never had a kidney problem."
Eau Claire, WI: "In December 2006 my uncle went into hospital to have heart bypass surgery. He spent two days in ICU and by Wednesday he was up and walking around. On Thursday he was looking forward to going home. Right after his walk he went into shock. They rushed him into surgery where he suffered kidney failure. He died that afternoon," said Rick Mason (not his real name pending a lawsuit).
A Chronological Account of Trasylol Troubles
January 25, 2006: A study was published in the New England Journal of Medicine stating that Trasylol (aprotinin), doubles the risk of kidney failure and stroke and increases the risk of heart failure or heart attack by 55 percent - alarming statistics. The study also concluded that substituting one of two safe generic drugs would prevent as many as 11,050 dialysis complications per year.
February 2006: The FDA reassessed the safety of Trasylol in response to two separate studies (the one above and another study conducted by Bayer which also found that the drug was linked to kidney problems and other serious side effects.) The agency issued a Public Health Advisory regarding these new findings with Trasylol.
September 21, 2006: FDA held a public meeting of the Cardiovascular and Renal Drugs Advisory Committee to discuss the safety and overall risk-benefit profile for Trasylol. The committee discussed the findings from the two published observational studies, a Bayer worldwide safety review, and the FDA review of its own post-marketing database, and made recommendations for labeling changes.
At that meeting, Bayer representatives withheld critical information from FDA health officials to address health concerns over Trasylol.
September 29, 2006: the FDA announced that Bayer informed the agency of another safety study conducted on September 27, 2006. Preliminary results indicated that, in addition to serious kidney damage, Trasylol may increase the chance for death, congestive heart failure, and strokes.
December 15, 2006: In light of an FDA-conducted review of safety information, the agency approved revised labeling for Trasylol to strengthen its safety warnings and to limit its approved usage to specific situations. "The purpose of the label change is to inform physicians and patients about the risks associated with Trasylol and to ensure they understand the new warnings and use the product as directed by the label," said Dr. Steven Galson, Director of FDA's Center for Drug Evaluation and Research.
The new labeling specifies that Trasylol should only be given to patients who are at an increased risk for blood loss and blood transfusion in the setting of coronary bypass graft surgery when patients undergo cardiopulmonary bypass. The changes also include a warning that Trasylol increases the possible risk for kidney damage, and suggest ways to manage and reduce the patient's risk for hypersensitivity reactions.
Meanwhile, Bayer has disputed the findings in the New England Journal of Medicine and continues to manufacture and distribute Trasylol. It is estimated that the injectable drug may have been given to as many as 1 million patients since its approval by the FDA 13 years ago.
Statute of Limitations
Be aware that the statute of limitations can apply for a Trasylol lawsuit. There is a maximum amount of time allowed after an event and each state has different time frames specific to the legal issues involved. If you are considering legal action, it is advisable that you act now rather than wait for the statute of limitations to possibly expire. Discuss your case with a Trasylol lawyer to find out if you are eligible for recourse.
If you or a loved one has experienced kidney or heart failure after heart surgery, and have been administered Trasylol, please contact a [Trasylol] lawyer who will evaluate your claim at no charge.