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Trasylol Recall - FDA Suspends Marketing of Trasylol (Aprotinin)

The following information on the Trasylol recall is provided by the law firm of Pritzker | Olsen, P.A. & Associates, a leading personal injury law firm with extensive experience representing people with kidney damage. The firm is actively investigating cases involving kidney damage and the use of Trasylol. The firm has a national reputation, and attorneys at the firm have been interviewed by The New York Times, The Wall Street Journal, Lawyers USA and other publications. Fred Pritzker, Elliot Olsen and Eric Hageman have been named "Super Lawyers" by Law & Politics magazine. To contact a lawyer at the firm about the Trasylol recall, Trasylol kidney damage and a Trasylol lawsuit, please call toll-free at 1-888-377-8900, email Fred Pritzker (lead attorney for the Trasylol cases), or submit the firm's free case consultation form.

Bayer Removes Trasylol from U.S. Market

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 will work with Bayer to ensure a smooth and complete process.
Under a limited use agreement, access to Trasylol is limited to investigational use of the drug according to the procedures described in a special treatment protocol. The 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.

FDA Requests Marketing Suspension
of Trasylol (Trasylol "Recall")

November 5, 2007 - The U.S. Food and Drug Administration (FDA) today 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. [This is essentially a Trasylol recall.]

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.

Two weeks ago, 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.

The FDA Trasylol "recall" discussed above and related issues was the subject of a recent piece that appeared on the CBS news program, 60 Minutes.

If you need a Trasylol lawyer for a Trasylol lawsuit, contact us.

 


 


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