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Bayer Defending Trasylol Despite Study Findings

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Los Angeles, CAAs more reports about the dangers of Trasylol are made public, Bayer A.G. defending itself and its drug more often. In the past year, two studies have shown that use of Trasylol can increase the risk of death in heart surgery patients.

Furthermore, the U.S. Food and Drug Administration (FDA) announced that Bayer withheld information about the risks associated with taking Trasylol.

Most recently, a study published in the Journal of the American Medical Association (JAMA, February 7, 2007), has shown that taking Trasylol can actually increase the risk of death in the five years following coronary artery bypass graft surgery. According to the study, 20 percent of patients treated with Trasylol died in the five years following their surgery compared with 12.7 percent of patients that did not receive Trasylol following surgery.

The study found that other drugs, aminocaproic acid and tranexamic acid, are safer to use than Trasylol. Aminocaproic acid, also known by its brand name Amicar, is used to treat severe bleeding in patients who experience blood clots that dissolve faster than normal. Tranexamic acid, known by its brand name Cyklokapron, is used for up to a week in order to prevent excessive bleeding and to reduce the need for transfusions. Both drugs work by preventing the breakdown of blood clots.

In addition to being safer, use of the other two drugs is far less costly than use of Trasylol. Trasylol costs over $1,000 per patient whereas the other drugs cost between $10 and $50 per patient.

Bayer, maker of Trasylol, has dismissed the research as 'unreliable' and 'limited'. However, a study completed just over a year ago found that Trasylol increased the risk of kidney failure, heart attacks, and strokes. The authors of the study also stated that there are other drugs that patients can take which are more effective than and not as costly as Trasylol. The study was published in the New England Journal of Medicine (January 26, 2006).

The FDA warned doctors in September, 2006, that patients who are given Trasylol should be monitored for brain, kidney, and heart toxicity. The warning was issued after the FDA was alerted to a Bayer study that showed Trasylol could increase the risk of serious occurrences including kidney damage, heart failure, strokes, and in extreme cases, death. The FDA also recommended that Trasylol should only be used in situations in which the risk of blood loss outweighs the risks of using the drugs.

The FDA learned of the study from an anonymous researcher who was involved in Bayer's Trasylol studies. Bayer itself did not inform the FDA that the study was being conducted. In fact, scientists from Bayer attended a public meeting on September 21 to discuss the serious risks associated with Trasylol and did not mention the study or the results of the study at that meeting.

Trasylol, known generically as aprotinin, is given before surgery to reduce blood loss and the need for blood transfusions for patients who have had certain heart surgeries. Trasylol can also cause serious allergic reactions including tightness in the chest, swelling in the face, a drop in blood pressure, and loss of consciousness.

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If you have suffered kidney failure, heart problems, or other complications after surgery, please contact a [Trasylol] lawyer who will evaluate your claim at no charge.

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