Trasylol® (aprotinin)
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If you have had heart surgery, then suffered from kidney failure and dialysis, you may have been treated with Trasylol®, a drug administered during heart surgeries which studies have shown to potentially cause post-surgical kidney failure requiring dialysis.
Trasylol Update- November 2007: The FDA has suspended marketing of Trasylol. Trasylol (aprotinin injection), an antifibrinolytic, is administered to patients during cardiac bypass and other complex heart surgeries to reduce blood loss. Preliminary results from a Canadian study suggested an increased risk of death for Trasylol users compared with two other antifibrinolytic drugs, prompting the FDA to suspend marketing of the drug. Reports have linked Trasylol with kidney problems, amputations, heart attacks and strokes. Trasylol is manufactured by Bayer Pharmaceutical.
Trasylol ® (aprotinin) is an injectable medication used to prevent excessive blood loss during heart surgery. A recent national study at Harvard University School of Public Health has found that the drug, which is manufactured by Bayer Pharmaceuticals, may be linked to serious complications including kidney failure and heart problems. The study found the drug increases the risk of heart failure and heart attack by nearly 55%. On September 29, 2006 the FDA announced that Bayer failed to reveal the results of a large study that implicated Trasylol ® with an increase of “STROKE & DEATH”
The sad truth is giant pharmaceutical companies and a handful of medical device manufacturers have put the public at risk by bringing dangerous or defective products to market. In the case of Bayer’s drug Trasylol®, studies have shown an increased risk of strokes, kidney failure, heart attack and even death.
In the study, 4,374 heart surgery patients worldwide were examined and found that those on Trasylol® were at twice the risk of suffering kidney failure, a heart attack, or heart failure. Trasylol® was approved in 1993 by the FDA and is the only Serpin¹ approved by the FDA for use to reduce blood loss during surgery and to reduce the need for blood transfusion for patients undergoing CABG with cardiopulmonary bypass.
Trasylol ® has been on the market for more than 13 years and is used to prevent bleeding during surgery and to reduce inflammation. A recent study of Trasylol demonstrated side effects including an increased risk of stroke, kidney failure, heart attacks and death.
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.
Trasylol® Side Effects:
- Difficulty breathing or shortness of breath
- Increased heart rate
- Nausea and vomiting
- Skin irritation and inflammation
- Sudden chest, leg, head, or groin pain
- Swelling of the face, lips, tongue, or neck
Unlike its generic competitors, Trasylol® is made from bovine lungs. As studies have now shown, Trasylol® is significantly more dangerous than similar drugs used to reduce blood loss. There were two generic drugs examined in the New England Journal of Medicine study, aminocaproic acid and tranexamic acid, they were found to be significantly more safe and just as effective as Trasylol®.
Have you or a friend or loved one had open heart surgery and subsequently have had kidney failure?
Unsure if You have a Case? Contact Bell & Bands Today.
Dangerous drug and defective medical device cases can be complicated. If you're not sure whether you have a reason to file a lawsuit, contact Charleston defective drug attorneys and medical device recall lawyers at Bell & Bands. We provide free consultations and will evaluate the facts of your case to determine the legal options available to you.
¹ Serpin is a serine protease inhibitor which is used to reduce blood loss during surgery and the need for blood transfusion.