Trasylol: The Side Effects could Kill You

San Bruno, CANo one would argue the benefits of Trasylol for heart surgery. Effective for helping to minimize blood loss during surgical procedures, Trasylol nonetheless presents the potential for extreme side effects to internal organs: specifically the kidney, the brain and the heart.

With the American Heart Association reporting more than six million cardio vascular procedures every year, Trasylol's dark side has the capacity to impact a great many Americans.

Two studies on Trasylol - which has been available and in widespread use since 1993 - expand on that possibility. The Ischemia Research and Education Foundation, based in California, examined 4,374 heart surgery patients globally and discovered Trasylol posed some alarming risks in patients that were administered Trasylol.

The risk for heart failure was more than double those not given Trasylol. Risk of kidney failure doubled, with a corresponding rise in dialysis use. The potential for stroke was found to be 181 per cent higher. Trasylol is suspected in some patient deaths.

The U.S. Food and Drug Administration (FDA) issued a public health warning in September of 2006, and suggested that Bayer had dropped the ball by not alerting the public to the results of a study that concluded in the risks posed by Trasylol.

Bayer, while acknowledging the existence of the study, replied that it was hesitant to release the findings, as they were preliminary.

According to the FDA in an update to the product labelling in December of last year, Trasylol is restricted for use only with patients undergoing coronary bypass graft surgery, which is part of the cardiopulmonary bypass procedure. Of those patients, only those at risk for blood loss and transfusion should be administered the drug. Trasylol works by disabling the enzymes that dissolve blood clots.

The numbers would be less sever had Trasylol only been used where it should. But once again, in an environment that is becoming increasingly commonplace in the healthcare and drug industry, the off-label use of Trasylol, administered to patients for whom it was never intended, has exploded the risk. For example, Trasylol was not approved for heart valve replacement surgery. However the FDA's own Adverse Event Reporting System shows that 75 per cent of reported incidents were linked to patients administered Trasylol off-label for an unapproved use, with heart valve surgery the biggest culprit.

Even so, Bayer had been lobbying the FDA for expanded approvals for Trasylol use in spinal fusion and hip replacement surgeries, until the release of study data sounded the alarm and put an end to those plans for the time being.

Some have called for the removal of Trasylol from the market. However, the FDA has chosen instead to initiate a re-assessment of risks associated with the drug. Bayer has since submitted new data based on their own findings.

That hasn't satisfied the nay Sayers, among them Dr. Dennis Mangano. He was the lead author on a study that appeared in the Journal of the American Medical Association on February 7th of this year. In his report, Dr. Mangano suggests that the anti-clotting agent may have been responsible for some 10,000 deaths over the past five years.

Some health care centres have stopped using Trasylol: Among them, Lakeland Regional Medical Centre in Florida, which discontinued use of the drug after the latest negative findings were published.

It sure wouldn't hurt the bottom line. Alternatives that are known to be reliable and effective, such as aminocaproic acid and tranexamic acid, are also far less expensive than Trasylol aprotinin - at $11, and $44 per patient, says Dr. Mangano.

The cost of Trasylol: $1300 per patient.

The potential cost to human lives: Incalculable.