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Minnesota Trasylol Kidney Failure and Stroke Center
Minnesota Trasylol Heart Surgery Risks
Aprotinin was approved by the U.S. Food and Drug Administration in 1993 and is manufactured by Bayer under the brand name Trasylol. Over the past several years Trasylol sales have accelerated, with 2006 sales projected in excess of $600 million.
It is estimated that as many as 10,000 patients may be unnecessarily on kidney dialysis today due to aprotinin use. Many patients undergoing heart surgery in Minnesota were given Trasylol to help reduce blood loss during coronary artery bypass (CABG) surgery.
Most Minnesota patients undergoing heart surgery are unaware if they were given Trasyol during their surgery. The decision to use aprotinin (Trasylol) was made by their treating physician.
Trasylol Linked to Heart Attacks and Kidney Failure
A 2006 study published in the New England Journal of Medicine (NEJM), reported an association of Trasylol with increased risk of developing renal (kidney) failure, myocardial infarction, heart failure or stroke in patients undergoing heart surgery.
What is Aprotinin Injection?
Aprotinin (Trasylol) affects the way in which blood clots. It is administered to patients who are undergoing open heart surgery. Excessive bleeding during and after heart surgery is a serious complication exposing patients to multiple risks. Aprotinin is mainly used during repeat coronary artery bypass surgery to reduce the amount of bleeding both during and after surgery. This reduces the amount of blood transfusion required.
Alternative Drugs Available – Safer & Less Expensive
The (NEJM) study concluded that 2 other generic drugs are available that are safer and less expensive than Trasylol. The Trasylol cost per dose is $1,300, the generic Amicar is $11 per dose and the generic drug, Cyklokapron is $44 per dose. Neither of the generic drugs was associated with increased risk of kidney, cardiac or cerebral events.
Trasylol Kidney Failure and Heart Failure Warnings
On September 21, 2006, the FDA’s Cardiovascular and Renal Drug Advisory Committee met to review recent data regarding the safety of aprotinin. On September 29, 2006, the FDA issued a public health advisory stating that it had learned Bayer Pharmaceuticals failed to disclose a study that it had conducted involving 67,000 patients undergoing heart surgery. Preliminary analysis of this study suggested that aprotinin use was linked with risk for congestive heart failure, stroke, kidney dysfunction, and death. This study was not reported during the September 21, 2006 Advisory Committee meeting. |
