Trasylol Recall and Lawsuit

FDA Requests Marketing Suspension of Trasylol
Source: The FDA

The U.S. Food and Drug Administration (FDA) announced that, at the agency's request, Bayer Pharmaceuticals Corp. has agreed to a marketing suspension of Trasylol, a drug used to control bleeding during heart surgery, pending detailed review of preliminary results from a Canadian study that suggested an increased risk for death.

FDA requested the suspension in the interest of patient safety based on the serious nature of the outcomes suggested in the preliminary data. FDA has not yet received full study data but expects to act quickly with Bayer, the study's researchers at the Ottawa Health Research Institute, and other regulatory agencies to undertake a thorough analysis of data to better understand the risks and benefits of Trasylol.

There are not many treatment options for patients at risk for excessive bleeding during cardiac surgery. Thus, FDA is working with Bayer to phase Trasylol out of the marketplace in a way that does not cause shortages of other drugs used for this purpose. Until FDA can review the data from the terminated study it is not possible to determine and identify a population of patients undergoing cardiac surgery for which the benefits of Trasylol outweigh the risks. Understanding that individual doctors may identify specific cases where benefit outweighs risk, FDA is committed to exploring ways for those doctors to have continued, limited access to Trasylol.

FDA was notified that researchers with the Ottawa Health Institute stopped a study on Trasylol because the drug appeared to increase the risk for death compared to two other antifibrinolytic drugs used in the study. Antifibrinolytic drugs help slow the breakdown of blood clots and subsequent excessive bleeding. The preliminary data from this terminated study also suggested that fewer patients receiving the drug experienced serious bleeding events.

On Oct. 26, FDA issued an Early Communication about an Ongoing Safety Review of Trasylol in response to the Canadian study's termination. In 2006, 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.

Related Articles and News on Trasylol:
Frequently Asked Questions on Trasylol
FDA Public Health Advisory on Trasylol
Trasylol Pulled From Worldwide Market
Bayer Will Begin Pulling Remaining Stock of Trasylol
FDA Requests Marketing Suspension of Trasylol
Transcript of FDA Press Conference on Trasylol

What Is Trasylol?
Trasylol is a medicine given before heart surgery to reduce bleeding and the need for blood transfusions.  Trasylol is made from tissue taken from cows.

What Are The Risks?
The following are the major potential risks and side effects of Trasylol therapy. However, this list is not complete.
Serious Allergic Reaction (Anaphylactic Reaction) This is a rare but serious allergic reaction that happens suddenly and can be life threatening or cause death.Patients who have had Trasylol in the past have a higher chance for anaphylactic reactions with a new dose of Trasylol.

Have you had a severe reaction or side effects from Trasylol?

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