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Trasylol (aprotinin injection)
Audience: trasylol
[UPDATE 05/14/2008] Following publication of the Blood conservation using antifibrinolytics: A randomized trial in a cardiac surgery population (BART) study in the May 14, 2008 online issue of The New England Journal of Medicine, Bayer Pharmaceuticals notified the FDA of their intent to remove all remaining supplies of Trasylol from hospital pharmacies and warehouses. 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.

[Posted 11/05/2007] FDA announced that, at the agency’s request, Bayer Pharmaceuticals Corp. has agreed to a marketing suspension of Trasylol (aprotinin injection), 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.

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. However, 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. 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.

[May 14, 2008 - Drug Information Page - FDA]
[May 14, 2008 - FDA News - FDA]
[November 5, 2007 - FDA News - FDA]

Previous MedWatch Alert:

[October 25, 2007]

Trasylol Deaths & Injuries – Drug Side Effects and Recall

Thought to be the next billion-dollar drug for pharmaceutical giant Bayer, Trasylol was designed to control bleeding during heart surgery. As early as the 1980s, warnings from drug researchers indicated that the drug may cause deadly side effects. However, these reports did not derail Bayer’s tenacious pursuit of FDA approval and worldwide distribution of Trasylol. The negligent release of Trasylol despite health warnings has caused thousands of patients worldwide to suffer serious injury and/or death. The personal injury lawyers and wrongful death attorneys at Phillips & Associates are dedicated to helping injured victims and their families file lawsuits against Bayer in order to obtain justice and rightful financial compensation.

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May 26, 2008 - Posted by | 4LIFE, artikel, BARAH, indonesia, JANTUNG, kanser, KESIHATAN, malaysia | , , , , , , , , , , , , , , , , , , , ,

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