March 16, 2006 at 13:53:59

Trasylol Patients and Clinical Trial Subjects Beware

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By Evelyn Pringle (about the author) Page 2 of 2 page(s)

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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."

For more information for injured parties go to Lawyers and Settlements at:

http://www.lawyersandsettlements.com/articles/trasylol_clinicaltrial.html

By Evelyn Pringle
evelyn.pringle@sbcglobal.net

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Evelyn Pringle is a columnist for OpEd News and investigative journalist focused on exposing corruption in government and corporate America.

The views expressed in this article are the sole responsibility of the author
and do not necessarily reflect those of this website or its editors.

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