Evelyn Pringle January 2006
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.
Experts say the IREF study provides compelling evidence of serious risks caused by Trasylol, and calls for the discontinuation of the drug and replacement with one of the 2 alternative products.
Neither aminocaproic or tranexamic was associated with an increased risk of renal, cardiac or cerebral events and both are much cheaper, costing $11 and $44 per dose, respectively, compared to the $1,300 per dose price tag of Trasylol.
The researchers estimate that by switching from Trasylol to the alternatives, $250 million a year could be saved in health care costs, in addition to helping over 10,000 patients a year to avoid the dangers and cost of kidney dialysis.
The findings of the Trasylol study is the 4th major cost-saving discovery by Dr. Mangano and his IREF-McSPI colleagues over the past ten years.
In other studies, according to the Baltimore Sun, "the group has shown that giving inexpensive beta-blockers after major surgery could save 250,000 lives per year, that aspirin use after heart surgery reduces the risk of blood clots and that the painkiller Bextra is associated with stroke and impaired wound healing."
In 1996, the team found that generic beta-blockers reduced death after major surgery, saving 250,000 lives a year at a cost of a mere $15 per patient, according to the New England Journal of Medicine.
In 2002, Dr. Mangano recommended giving heart patients aspirin immediately after surgery to reduce the threat of thrombosis. This is now a standard practice and saves over 25,000 lives a year at a cost of pennies per patient.
In 2003, IREF- McSPI reported for the first time that Bextra, was associated with stroke and impaired wound healing, eventually leading to the drug's recall, according to J Thoracic and Cardiovascular Surgery.
For 2005, according to Bloomberg News, Bayer predicted Trasylol sales to bring in $614 million. However, on January 26, 2006, Bloomberg reported that shares of Bayer, "the German drugmaker that invented aspirin, fell 48 cents ... at the close of trading in Frankfurt after U.S. researchers published their findings in this week's New England Journal of Medicine."
If the IREF's findings result in the removal of Trasylol, the loss in sales could push Bayer stock-value into a free-fall during 2006.
The problem for surgery patients who may have been harmed by Trasylol, is that most people are never told what drugs they received during surgery. And while Trasylol is only approved for heart surgery, the drug has been used off-label during many other types of surgeries as well.
So who knows how many unsuspecting victims have been injured by this drug while under the knife.