Experts are sounding the alarm that patients who received the drug Trasylol (generic aprotinin), during a surgical procedure may have suffered kidney failure, a heart attack, heart failure, or a stroke as an adverse event caused by the drug.
The results of a study, published last month in the New England Journal of Medicine, by the independent, non-commercial, Ischemia Research and Education Foundation (IREF), found Trasylol associated with a 2-fold increase in renal failure requiring dialysis in patients undergoing major surgery.
The study data was gathered from patients who had surgery between 1996 and 2000, at more than 69 medical centers around the world, and received either Trasylol, aminocaproic acid, tranexamic acid, or no drug treatment.
The study's control group of 1,374 patients, received a placebo, while 1,295 patients received Trasylol, 883 others received aminocaproic, and 822 patients received tranexamic.
The study found that the use of Trasylol increased the risk of stroke by 181%, myocardial infarction by 48%, and heart failure by 109%, when compared to people who received the 2 alternate drugs.
The researcher's determined that patients treated with Trasylol, had a risk of kidney failure 259% greater than patients who received no drugs.
German based drug maker, Bayer Pharmaceuticals, has said the results of the IREF study are inconsistent with its own clinical data. In fact, prior to the release of the study, the company had filed a request for FDA approval for the use of Trasylol during spinal and hip surgery. Experts say that approval is unlikely now.
The new study was conducted by a consortium of surgeons called the Multicenter Study of Perioperative Ischemia Research Group, in San Bruno, California.
Surgeons and anesthesiologists had suspected problems with the drug for years, but the number of side effects was lost among the huge number of patients given the drug. "We didn't have good, hard data to prove it," said Dr. O. Wayne Isom, chairman of the department of cardiac and thoracic surgery at New York Presbyterian Hospital/Weil Cornell Medical College, to the Baltimore Sun on January 26, 2006.
The new results are "pretty much undebatable," Dr Isom added.
Dennis Mangano, PhD, MD, the founder of the IREF, and the study's lead researcher said that the study's findings -- "coming on the heels of the Vioxx experience -- indicate that the problem of drug safety is not only ubiquitous, but also much more elusive than previously thought," according to Consumer Affairs.com. In fact, Mangano said, the findings raise even more concerns than Vioxx because:
(1) aprotinin has been on the market for three times as long as Vioxx, yet few comprehensive safety studies have been conducted since approval;
(2) the life-threatening complications with aprotinin occurred far more frequently than those with Vioxx; and
(3) far less expensive generic alternatives to aprotinin which are equally effective in limiting bleeding have been available, but have been underused, Consumer wrote.
Although Trasylol use is approved in more than 60 countries worldwide, in the US, it gained FDA approval in 1993, but only for use to control bleeding in patients undergoing coronary artery bypass graft surgery (CABG), to reduce the need for blood transfusions. The drug is said to work by blocking enzymes that dissolve blood clots.
CABG is the most commonly performed major surgery in the US, with approximately half a million patients undergoing the procedures each year, according to Heart Disease and Stroke Statistics - 2005 Update.
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