Thirteen years ago, the FDA approved Trasylol (aprotinin) for use in patients undergoing heart bypass surgery. In January 2006, doctors, consumer advocates and a medical research group called for the removal of the drug from the market after a study found it to have deadly side effects.
Heart bypass surgery is performed to redirect blood around clogged arteries to increase blood flow and oxygen to the heart. A patient may undergo one, two, three or more bypasses depending on how many arteries are blocked. It is the most commonly performed major surgery in the US, with approximately 500,000 procedures conducted each year, according to Coronary Artery Bypass Graft Surgery at Heart Center Online.
The FDA approved Trasylol in 1993 to control bleeding in patients undergoing heart surgery by blocking enzymes that dissolve blood clots. Although it was only approved for heart surgery, the drug has been administered off-label to patients undergoing other types of surgery.
Because the majority of patients are unaware of the drugs they receive during surgery, and also because of Trasylol's off-label use, medical experts say patients need to check with their doctors to see whether they received the drug.
Since Trasylol was approved, an estimated 1 million people world-wide have received the drug. The new study published in the January 26, 2006 New England Journal of Medicine (NEJM), found patients who received Trasylol (aprotinin) have experienced potentially deadly side effects including:
• A twofold increase in kidney failure
• A 48-percent increase in risk of heart attack
• A 109-percent increase in heart failure
• A 181-percent increase in stroke
Researchers estimates that as many as 10,000 heart surgery patients have experienced kidney failure and are now on dialysis because they were given Trasylol.
The study was conducted by a consortium of surgeons called the Multicenter Study of Perioperative Ischemia Research Group, sponsored by the California-based Ischemia Research and Education Foundation (IREF), and led by IREF founder Dr Dennis Mangano, MD, Ph D.
"Our findings raise serious concerns regarding the safety of an approved drug intended to limit blood loss in at-risk patients undergoing surgery," wrote Dr Mangano in the NEJM.
Another study published in the January 20, 2006 online edition of the journal Transfusion reported a similar increase in renal problems among patients given Trasylol while undergoing cardiac surgery with cardiopulmonary bypass.
Trasylol was the second clotting medication in two weeks linked to serious complications. according to the Associated Press on January 26, 2006. Other researchers reported that the hemophilia drug Novoseven was linked to deaths, heart attacks and strokes in patients who took the drug to treat other types of excessive bleeding such as cerebral hemorrhagesm, it wrote.
Trasylol is manufactured by German-based Bayer Healthcare Pharmaceuticals. The FDA has so far refused to remove the drug from the market, but on February 8, 2006, it posted a public health advisory on its web site that said, while FDA is continuing its evaluation, we are providing the following recommendations to healthcare providers and patients:
Physicians who use Trasylol should carefully monitor patients for the occurrence of toxicity, particularly to the kidneys, heart, or central nervous system and promptly report adverse event information to Bayer, the drug manufacturer, or to the FDA MedWatch program, as described at the end of this advisory.
Physicians should consider limiting Trasylol use to those situations where the clinical benefit of reduced blood loss is essential to medical management of the patient and outweighs the potential risks.
The NEJM study comes at a time when Bayer is pushing to have the drug approved for other surgery. The company recently filed a request seeking FDA approval for the use of Trasylol for hip and spinal surgery.
On December 8, 2005, Bayer announced the initiation of a Phase III clinical trial to evaluate the safety and efficacy of Trasylol in reducing blood loss and the need for transfusion in adult patients undergoing elective spinal fusion surgery, in a press release.
According to the press release, over 450 adult patients will participate in the study in 40 investigational centers in North America. The company says Trasylol is currently approved for use in more than 60 countries.
In an editorial accompanying the study in the NEJM, Dr Gus Vlahakes, MD, of Harvard Medical School noted that efforts were underway to expand the indications for Trasylol and that the new indications may require a higher dose.
"Until the safety of higher doses is fully explored in a prospective study, the expansion of indications for aprotinin may be premature," he warned in the editorial.
According to IREF, each year nearly 1 million people worldwide undergo surgery following a heart attack and the majority of the patients receive one of 3 different drugs used to limit blood loss: aprotinin, aminocaproic acid, and tranexamic acid.
The IREF researchers studied 4,374 patients from around the world, comparing Trasylol with 2 alternative drugs or no drugs at all, and determined that the alternatives did not have the harmful side effects of Trasylol.
In light of these findings, IREF said that the other 2 drugs are "underused", although they are "equally effective in limiting bleeding," have been proven safe, and are readily available. In addition, the two alternatives drugs cost only a tenth of the cost of Trasylol.
Trasylol is a $600 million per year drug, Dr Mangano told Reuters News on January 25, 2006. "It would have been a blockbuster for them," he said.
The two alternative drugs are much cheaper. A full dose of Trasylol costs $1,300 per patient, while the other two are just $11 and $44, according to Dr Mangano.
The study contends that replacing Trasylol with one of the drugs could prevent as many as 11,050 dialysis complications each year and save at least $1 billion in health care costs and reduce drug costs by at least $250 million.
IREF says it provided all the funding for the study, totaling more than $35 million. The 69 participating cardiac centers also contributed through reduced research and data collection fees and that none of the study's authors received direct or indirect support from any of the manufacturers of the three drugs studied.
According to the January 26, 2006 Baltimore Sun, surgeons and anesthesiologists had suspected potential problems with Trasylol for many years, "but the number of adverse side effects was lost among the huge number of patients given the drug."
The "associations between aprotinin and serious end-organ damage indicates that continued use is not prudent," Dr Mangano wrote in the study. "In contrast, the less expensive generic medications aminocaproic acid and tranexamic acid are safe alternatives."
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Trasylol Patients and Clinical Trial Subjects Beware
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