Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

originally used to reduce bleeding during complicated surgery, trasylol was recalled by manufacturer Bayer in 2007 and permanently withdrawn in 2008

On January 26, 2006, The New England Journal of Medicine (NEJM) published an article by Mangano et al. reporting an association of Trasylol (aprotinin injection) with serious renal toxicity, myocardial infarction and stroke in patients undergoing coronary artery bypass grafting surgery.

On February 8, 2006, the Food & Drug Administration (FDA) issued a Public Health Advisory noting that it was evaluating the NEJM study, along with other studies and adverse affect reports submitted through its MedWatch voluntary reporting program. Physicians were advised to 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. Physicians also were advised to limit Trasylol use.

On September 21, 2006, FDA held a public meeting of the Cardiovascular and Renal Drugs Advisory Committee to discuss the safety and overall risk-benefit profile for Trasylol.  At that meeting, the committee discussed the findings from the two published observational studies, a Bayer worldwide safety review, and the FDA review of its own post-marketing database, and made recommendations for labeling changes.

FDA announced on September 29, 2006, that Bayer informed the agency of an additional safety study on September 27, 2006.  The preliminary results from that study suggest that in addition to serous kidney damage, Trasylol may increase the chance for death, congestive heart failure (a weakening of the heart), and strokes.

In a Public Health Advisory Update dated October 3, 2006, the FDA recommended that “physicians consider limiting Trasylol use to those situations in which the clinical benefit of reduced blood loss is necessary to medical management and outweighs the potential risks” and carefully monitor patients.

On October 29, 2006 the Food and Drug Administration issued a warning that aprotinin may have serious kidney and cardiovascular toxicity. The producer, Bayer, reported to the FDA that additional observation studies showed that it may increase the chance for death, serious kidney damage, congestive heart failure and strokes.

December 15, 2006, the FDA approved revised labeling for Trasylol (aprotinin injection) to strengthen its safety warnings and to limit its approved usage to specific situations. The labeling changes for Trasylol are based on the recommendations of the September 2006 advisory committee.

On November 5, 2007, the U.S. Food and Drug Administration announced that Bayer Pharmaceuticals Corp. agreed to an FDA-requested marketing suspension of Trasylol. At that time, preliminary results from a Canadian study suggested an increased risk for death compared to two other drugs used to control bleeding.

On May 14, 2008, the FDA announced Bayer had removed all remaining stocks of Trasylol from distribution in the U.S., and would limit access to the product to investigational use. The limited use agreement protocol allows treatment for certain patients who are at increased risk of blood loss and transfusions during coronary artery bypass graft surgery and who have no acceptable alternative therapy. Physicians using Trasylol in this situation must also verify that the benefits of the drug clearly outweigh the risks for their patients.

Do you have a trasylol claim?

If you or your loved one has suffered a serious injury or death as a result of trasylol, you may be entitled to compensation for medical expenses, loss of wages, and pain and suffering.

Please contact our trasylol lawyers today by filling out the brief questionnaire, or by calling our toll free number (1-800-898-2034) for a free, no-cost, no-obligation legal evaluation of your case.

Trasylol is a medication administered by injection to reduce bleeding during complex surgery, such as heart and liver surgery

Trasylol (aprotinin), manufactured by Bayer, is a protein that is used as medication administered by injection to reduce bleeding during complex surgery, such as heart and liver surgery. Its main effect is the slowing down of fibrinolysis, the process that leads to the breakdown of blood clots. The purpose of Trasylol is to decrease the need for blood transfusions during surgery, as well as end-organ damage due to hypotension (low blood pressure) as a result of marked blood loss.

Bayer withholds critical information

In September 2006, Bayer Pharmaceuticals was faulted by the FDA for not revealing during testimony the existence of a commissioned study of Trasylol that concluded Trasylol carried greater risks. The FDA was alerted to the study by one of the researchers involved.

Trasylol recall

The drug was temporarily withdrawn worldwide in 2007 after studies suggested that its use increased the risk of complications or death; after this was confirmed by follow-up studies, Trasylol was entirely and permanently recalled in May 2008, except - at least for the time being - for very restricted research use.

Do you have a trasylol claim?

If you or your loved one has suffered a serious injury or death as a result of trasylol, you may be entitled to compensation for medical expenses, loss of wages, and pain and suffering.

Please contact our trasylol lawyers today by filling out the brief questionnaire, or by calling our toll free number (1-800-898-2034) for a free, no-cost, no-obligation legal evaluation of your case.

Beasley Allen law firm is actively pursuing Trasylol recall and Trasylol death claims in all 50 states

Our defective drug and product liability lawyers work solely on behalf of individual plaintiffs that were injured by defective products, such as heparin.

Over the past 29 years, we have successfully handled these types of claims, having recovered more than $20 billion in verdicts and settlements for our clients.

Frank Woodson is the Trasylol lawyer investigating claims on behalf of the firm.

Do you have a trasylol claim?

If you or your loved one has suffered a serious injury or death as a result of trasylol, you may be entitled to compensation for medical expenses, loss of wages, and pain and suffering.

Please contact our trasylol lawyers today by filling out the brief questionnaire, or by calling our toll free number (1-800-898-2034) for a free, no-cost, no-obligation legal evaluation of your case.

The FDA in conjunction with Bayer Pharmaceuticals, has recalled Trasylol, after results showed an increased risk of death

On May 14, 2008, Bayer HealthCare Pharmaceuticals Inc. has notified the FDA that the company will begin removing the remaining Trasylol stock from the U.S. market, most of which is in warehouses and hospital or physician’s stock. The FDA has agreed to work with Bayer to ensure a smooth and complete process.

FDA limits access to certain drugs to patients with serious or immediately life-threatening disease or conditions who lack other therapeutic options and may benefit from such therapies.

The Trasylol recall comes after a randomized Canadian study that prompted last November’s marketing suspension of Trasylol are expected to be published this week. The data contained in this article suggest that Trasylol appears to increase the risk for death compared to two other antifibrinolytic drugs used in the study.

Do you have a trasylol claim?

If you or your loved one has suffered a serious injury or death as a result of trasylol, you may be entitled to compensation for medical expenses, loss of wages, and pain and suffering.

Please contact our trasylol lawyers today by filling out the brief questionnaire, or by calling our toll free number (1-800-898-2034) for a free, no-cost, no-obligation legal evaluation of your case.