TRASYLOL (APROTININ) HEART SURGERY DRUG
Trasylol (aprotinin) heart surgery drug was removed from the U.S. market in May 2008 after 50% of patients were linked to serious side effects of: Trasylol was given to reduce blood loss in heart bypass surgery, but was taken off the market after Sixty Minutes exposed almost 50% of patients receiving the drug developed these serious life-threatening conditions after surgery. We are prosecuting these cases for our heart surgery clients who developed these serious effects after the operation. Click the blue links to watch the Sixty Minutes video and FDA warnings, click the arrow on the screen to watch the FDA video below: ⇒CBS '60 Minutes' report on Trasylol ⇒FDA Requests Marketing Suspension of Trasylol ⇒FDA Public Health Advisory for Trasylol ⇒New England Journal of Medicine article on Trasylol
Trasylol is manufactured by Bayer Pharmaceuticals Corporation and was approved by the Food and Drug Administration in 1993. Patients undergoing heart surgery and 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 heart surgeries. TRASYLOL INJURIES AND WARNINGS 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. 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". SAFER 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. 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 drugs in the United States is highly competitive and 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 Nations Law Firm has the commitment, the resources, the medical legal team 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. FREE CALL AND CASE REVIEW Contact us at 1-800-814-4540 or fill out the form below for a free case review by an experienced pharmaceutical lawyer.
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