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Bayer Lawsuit - Trasylol, Kidney Failure and Death

URGENT WARNING REGARDING TRASYLOL AND BAYER LAWSUIT INFORMATION: Due to possible increased risk for death and serious adverse events, Bayer has pulled Trasylol, a drug used to control bleeding during heart surgery, from the U.S. market. The information below on Bayer and Trasylol is provided by Pritzker | Ruohonen, a nationally-recognized 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, Rich Ruohonen and Elliot Olsen 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 Bayer lawsuit, please call toll-free at 1-888-377-8900, e-mail our attorneys (Fred Pritzker is managing attorney for the Trasylol cases), or submit the firm's free case consultation form.


Bayer Agrees to Marketing Suspension
of Trasylol (Trasylol "Recall")

On Nov. 5, 2007, the U.S. Food and Drug Administration announced that Bayer Pharmaceuticals Corp. agreed to an FDA-requested marketing suspension of Trasylol. Trasylol is an antifibrinolytic drug approved to reduce blood loss during surgery and the need for blood transfusion in certain patient undergoing cardiopulmonary bypass in the course of coronary artery bypass graft surgery. Antifibrinolyitc drugs help slow the breakdown of blood clots and subsequent excessive bleeding.

At the time of the marketing suspension, preliminary results from a Canadian study suggested an increased risk for kidney failure and death compared to two other drugs used to control bleeding.

Bayer Removes Trasylol from U.S. Market

On May 16, 2008, the FDA announced that Bayer HealthCare Pharmaceuticals Inc. had notified the FDA that the company would begin removing the remaining Trasylol stock from the U.S. market, most of which was in warehouses and hospital or physician’s stock at the time of the announcement.

Bayer and the FDA worked out a limited use agreement regarding Trasylol, under which 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 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. This type of access requires the submission of a protocol, which is reviewed and approved by the agency. Bayer has agreed to provide Trasylol through this mechanism for the limited use described above.

If you or a loved one has had a serious adverse event (including kidney failure or death) associated with the administration of Trasylol, please contact our law firm for Bayer lawsuit information.  To contact the firm, please call 1-888-377-8900 (toll-free), e-mail our lawyers or submit the firm’s free, online case consultation form.

Keywords: Bayer Lawsuit, Bayer Class Action, Lawsuit against Bayer, Trasylol

 


 


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