Trasylol use linked to increased risk of death, kidney or renal failure, heart attacks, strokes and encephalopathy among heart surgery patients. There may have been approximately 22,000 deaths associated with the use of Trasylol.
How much did Bayer know? And why did it take Bayer and the U.S. Food and Drug Administration nearly two years to take the drug off the market after major studies revealed the danger? Two years – during which it’s estimated Trasylol was contributing to the loss of one thousand lives a month.
CBS 60 Minutes – Trasylol may have caused over 22,000 deaths
Feb. 17, 2008 — CBS 60 minutes video titled, “One Thousand Lives A Month” Researcher Estimates 22,000 Lives Could Have Been Saved Had Trasylol Been Pulled Earlier
U.S. Food & Drug Administration (FDA) Trasylol Recall Video
Trasylol Lawsuit Update: On May 14, 2008, Bayer Pharmaceuticals notified the U.S. Food & Drug Administration (FDA) that they would be initiating a nationwide Trasylol recall.
Read the Full Transcript: Marketing of Trasylol Suspended
Schmidt & Clark has been actively pursuing Trasylol side effect cases since 2006. The Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus exclusively on the representation of plaintiffs in Trasylol lawsuits. We are handling individual litigation nationwide and currently accepting new Trasylol cases in all 50 states.
FDA Announces Suspension of Trasylol
November 5, 2007 –The U.S. Food and Drug Administration (FDA) today announced that, at the agency’s request, Bayer Pharmaceuticals Corp. has agreed to a marketing suspension of Trasylol, a drug used to control bleeding during heart surgery, pending detailed review of preliminary results from a Canadian study that suggested an increased risk for death.
What is Trasylol?
Trasylol (Generic: aprotinin) is an injectable prescription drug which inhibits certain enzymes that increase the risk of bleeding during surgery and aids the body’s ability to prevent bleeding.
Normally, the drug is given to patients undergoing heart bypass surgery to control blood loss, but has also been used in other surgeries, such as hip replacement surgery.
Trasylol is manufactured by Bayer Pharmaceuticals Corporation and was approved by the Food and Drug Administration in December 1993 to reduce bleeding and the need for blood transfusion in patients undergoing heart surgery.
What is the problem?
Beaking News: Recently, CBS 60 minutes released a segment titled, “One Thousand Lives A Month” Researcher Estimates 22,000 Lives Could Have Been Saved Had Trasylol Been Pulled Earlier.
Previous to this, on November 5, 2007 Bayer Pharmaceuticals Corp. has agreed to a marketing suspension of Trasylol, a drug used to control bleeding during heart surgery, pending detailed review of preliminary results from a Canadian study that suggested an increased risk for death.
Previously, The New England Journal of Medicine recently found the use of Trasylol doubled the risk of kidney failure, increased the chance of heart attack or heart failure by 55% and resulted in a 181% increase in the risk of stroke. Another study confirmed the increased risk of kidney failure with the use of Trasylol.
The lead author of the New England Journal of Medicine study, and his colleagues estimated that over 11,000 patients a year may now be on dialysis as a result of Trasylol use.
In an interview the Author said, Trasylol is “Vioxx 2.” Vioxx was removed from the market in 2004 due to an increase of heart attacks. The author also said that the frequency of adverse events from Trasylol were “far greater” than was seen with Vioxx.
11/5/07: FDA Requests Marketing Suspension of Trasylol
12/15/06: FDA Trasylol Label Change and Warning
12/15/06: MedWatch Trasylol Adverse Event Report
Must Read: FDA Trasylol Resource Page
New England Journal of Medicine Study: “The Risk Associated with Aprotinin in Cardiac Surgery“