TRASYLOL INFORMATION

If you or someone you know has experienced kidney failure, heart attack, myocardial infarction, stroke, encephalopathy or other serious side effects from receiving Trasylol in surgery, please contact our offices for a free case evaluation.

Since most patients are unaware of the medications used during their surgery, we recommend that you contact our offices if you have suffered from serious side effects after any surgery.

TRASYLOL ISSUES

• Drug administered during surgery to reduce blood loss
• Linked to an increased risk of serious kidney damage, heart attacks, strokes and death
• Marketing of Trasylol suspended in November 2007 due to risk of death
• Trasylol permanently removed from regular U.S. market in May 2008

If you or someone you know has experienced kidney failure, heart attack, myocardial infarction, stroke, encephalopathy or other serious side effects from receiving Trasylol in surgery, please contact our offices for a free case evaluation.

Trasylol, approved by the FDA in 1993, came under scrutiny beginning in January 2006 when studies showed dangerous risks associated with the drug. The FDA issued periodic warnings as they conducted ongoing safety reviews. Warnings were added to the Trasylol label in December 2006. When further research showed an apparent increased risk of death from Trasylol use, Bayer agreed to temporarily suspend marketing of the drug pending further review. In May of 2008, the FDA announced that Trasylol will no longer be available for regular use in the United States.

THE PRODUCT

Trasylol (also known by its generic name 'aprotinin') is manufactured by Bayer Pharmaceuticals Corporation and was approved by the Food and Drug Administration (FDA) in 1993. It is currently approved for use in more than 60 countries. Trasylol is the only product approved by the FDA for the prevention of blood loss during coronary artery bypass grafting (CABG) surgeries.

Patients undergoing CABG using cardiopulmonary bypass may be at risk for bleeding complications due to prior use of anticoagulants (blood thinning medications) or clinical conditions that predispose them to bleeding. Trasylol is used to decrease this bleeding risk. Trasylol inhibits certain enzymes that increase the risk for bleeding, thereby aiding the body's ability to prevent bleeding. Two other drugs, aminocaproic acid and tranexamic acid, although not approved by the FDA specifically for this purpose, are also used to reduce bleeding during CABG surgeries.

Although the FDA has only approved Trasylol for use in certain cardiac surgical procedures, it is often used in other types of procedures, such as orthopedic surgeries. Bayer currently has an application pending with the FDA for approval to use Trasylol in hip and spinal surgeries.

TRASYLOL INJURIES AND WARNINGS

In January of 2006, two Trasylol studies were published in the medical journals Transfusion and the New England Journal of Medicine. One study reported an increased risk of kidney failure, heart attack and stroke in patients treated with Trasylol as opposed to those treated with other drugs. The other study showed an increased risk of kidney damage compared to other drugs, but not an increased risk of heart attack or stroke. These studies triggered an FDA safety review of the risks of Trasylol.

On February 8, 2006, the FDA issued a Public Health Advisory to warn the public about the possible risks associated with Trasylol. Bayer Healthcare Pharmaceuticals issued a “Dear Health Care Provider” letter to inform doctors. The letter discusses the study results, but also challenges the accuracy of the results. The letter concludes by stating that "Bayer believes that Trasylol is a safe and effective treatment when used in accordance with the product labeling."

In September 2006, Bayer informed the FDA of alarming results from additional studies. The preliminary results suggested that in addition to serious kidney damage, Trasylol may increase the chance for death, congestive heart failure (a weakening of the heart), and strokes. The FDA issued another Public Health Advisory and continued their safety review.

On December 15, 2006, the FDA revised the labeling for Trasylol to strengthen its safety warning and limit its approved usage to patients at an increased risk for blood loss and blood transfusion during coronary bypass graft surgery. See FDA Press Release.

In October 2007, the FDA was notified that a Canadian study had to be stopped because Trasylol appeared to increase the risk of death, compared to the other drugs being studied. The FDA issued a preliminary statement to inform the public that, in light of the halted study, they would be re-evaluating the risks and benefits of Trasylol.

On November 5, 2007, the marketing of Trasylol was suspended pending a detailed review of the preliminary results of the Canadian study. See FDA Press Release and Bayer's "Dear Doctor letter".

In a May 14, 2008 Press Release, the FDA announced that Trasylol will no longer be available for regular use in the United States. It will now be limited to investigational use only. All remaining Trasylol stock is being removed from the U.S. market. This comes following the release of the Canadian (BART) study results (251Kb) which are to be published in The New England Journal of Medicine on May 29, 2008. The study suggests that Trasylol is linked to an increased risk of death compared with the two other drugs in the study.

SAFE ALTERNATIVES AVAILABLE

Based on the available studies, aminocaproic acid and tranexamic acid reduce blood loss during cardiac surgeries as effectively as Trasylol. Neither of these drugs have been shown to have the serious side effects associated with Trasylol. Additionally, there is a huge cost difference between these drugs and Trasylol as set out below:

• Trasylol (aprotinin) $1,300 per dose
• Amicar (aminocaproic acid) $11 per dose
• Cyklokapron (tranexamic acid) $44 per dose

Studies estimate that using a generic drug instead of Trasylol could save 9-11,000 people from kidney dialysis every year.

LEGAL RECOURSE

If Trasylol has been administered to you during surgery and you have suffered illness or injury as a result, you may be entitled to compensation. The Law Offices of Howard L. Nations represents people who have been injured by Trasylol. Contact our offices for a free consultation with one of our pharmaceutical attorneys.

Pharmaceutical companies owe a moral and legal responsibility to the public to ensure that the medications they manufacture and market are not unreasonably dangerous and to ensure that the consumer is made aware of the risks associated with the medication. The business of pharmaceuticals in the United States is highly competitive and is worth billions of dollars. Unfortunately, some pharmaceutical companies are hastily introducing and marketing new drugs prematurely and without adequate warnings, resulting in tragic losses that could have been avoided.

The Law Offices of Howard L. Nations has the commitment, the resources, and the experience necessary to stand up to the pharmaceutical giants and defend the rights of those people who have been wrongly and unjustly harmed.