Trasylol Recall Follows Kidney Failure Problems
On November 5, 2007, the U.S. Food and Drug Administration (FDA) announced that Bayer Pharmaceuticals Corporation agreed to a “marketing suspension” of its Trasylol drug. Trasylol is a drug that was designed to control bleeding during heart surgery. Two weeks before the FDA’s announcement, researchers from the Ottawa Health Institute notified the FDA that they had stopped a study on Trasylol because it appeared to increase the risk of death for patients, compared to two other drugs used in the study.
Prior to the Trasylol recall, Dr. Dennis Mangano, a medical researcher, published a study in the New England Journal of Medicine in January 2006 that patients who had been given Trasylol had twice the rate of kidney failure and an increased risk of strokes, heart attacks and encephalopathy (a type of brain disease).
After the Trasylol recall, two studies published on February 28, 2008 in the New England Journal of Medicine confirmed that patients who were given Trasylol had an increased risk of death. The release of these studies follows an interview of Dr. Dennis Mangano on the TV show 60 Minutes. Dr. Mangano contended that the FDA should have pulled Trasylol from the market after his study was released in January 2006. It is estimated that approximately 413,000 patients received Trasylol between the time of his study and the time of the recall. According to Dr. Mangano, 22,000 lives could have been saved if the drug had been taken off the market in January 2006.
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Bayer Withheld Trasylol Study
On September 21, 2006 The Federal Drug Administration’s Cardiovascular and Renal Drug Advisory Committee met to evaluate the most recent Trasylol study results regarding serious Trasylol side effects such as kidney failure. The committee evaluated the published studies and the global safety and efficacy database submitted by Bayer. After assessing all the data that was made available, the FDA committee determined that there was not enough evidence to require an updated warning on Trasylol’s labeling and agreed that the published data supported an acceptable safety level for Trasylol.
On September 29, 2006, only days after the committee meeting, the FDA received new data from Bayer regarding an additional Trasylol study that it had failed to reveal prior to the committee meeting. It was discovered that Bayer had commissioned their own observational study involving 67,000 patients who were administered Trasylol (aprotinin). Preliminary review of the new study data shows a potential for increased risk of Trasylol side effects including heart failure, stroke, kidney failure, and death. There was conflicting information as to why Bayer failed to disclose this important Trasylol study during the FDA’s Committee meeting on September 21, 2006.
The FDA issued a public health advisory on September 29, 2006, stating that it had received updated information regarding a Trasylol study that Bayer failed to disclose prior to the committee meeting. Analysis of the Trasylol study data is ongoing at the FDA, however the initial review of the study shows aprotinin may be linked with “increased risk for death, kidney failure, congestive heart failure and stroke.”
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Bayer HealthCare Pharmaceuticals, Inc. has been facing an increasing number of patients who have filed a Trasylol lawsuit over its Aprotinin heart surgery drug. The lawsuits allege that Bayer is liable for manufacturing and failing to warn Trasylol users of its dangerous side effects. The Trasylol lawsuits allege that Bayer knew Trasylol increases patients’ risk [...]
Until recently, Bayer’s anti-bleeding drug was used on a regular basis during heart surgery. Trasylol (Aprotinin) is widely used to decrease bleeding risk during coronary artery bypass graft (CABG) surgery. There are some common side effects that persist or become bothersome following use, including: constipation, diarrhea, difficulty urinating, infection (fever, chills, sore throat), lightheadedness, sleeplessness [...]
We represent all Trasylol lawsuits clients on a contingency basis which means that there are never any legal fees unless we win compensation in your case. For a free no-obligation consultation please call toll free at 1-888-343-5375 or fill out our short online contact form and a Trasylol lawyer will contact you to answer any of [...]
Trasylol Aprotinin Side Effects Study
Another study reveals an increased risk of serious Trasylol side effects leading to a higher mortality rate in aprotinin bypass patients. A recent study published in The New England Journal of Medicine on February 21, 2008 shows an increased risk of death for patients receiving aprotinin (Trasylol) during coronary-artery bypass grafting [...]
Trasylol Heart Surgery Drug Information
What is aprotinin injection?
APROTININ (Trasylol) is a drug that affects the way blood clots. It was given to heart surgery patients during bypass procedures. Aprotinin was mainly used during repeat coronary artery bypass surgery to reduce the amount of bleeding before and after surgery. Trasylol and other clotting medications help to [...]
