Litigation

Dangerous Heart Surgery Drug Trasylol Now Under Special Use Agreement

By Angel L. Reyes, III

Following a study published in the May 14, 2008 issue of The New England Journal of Medicine, Bayer Pharmaceuticals informed the FDA (Food & Drug Administration) of their plan to remove all remaining supplies of Trasylol (aprotinin injection) from hospital pharmacies and warehouses.  Due to the potential risks of this dangerous drug, which is used to prevent bleeding and blood clotting in patients during heart surgery, a special use agreement now limits Trasylol to treatment of patients who have no acceptable alternative therapy. Read the specifics of this special treatment protocol in the following FDA Alert:

Bayer Pharmaceuticals notified the FDA of their intent to remove all remaining supplies of Trasylol from hospital pharmacies and warehouses
Audience: Cardiac surgeons and other healthcare professionals
May 14, 2008
FDA.gov
Original FDA Article

[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.

©2008 Angel Reyes
www.ReyesLaw.com

Full post as published by Angel Reyes Blog on May 15, 2008 (boomark / email).