Aprotinin (Trasylol) withdrawn from US market
admin November 6th, 2007
News from the FDA:
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.
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.
The MHRA also state:
The UK Commission on Human Medicines will advise this week on any formal regulatory action and appropriate advice to UK prescribers. In the meantime, and as a precautionary approach, our advice is that aprotinin should only be used after careful consideration in individual cases where, for example, the risk of blood loss during surgery is considered to be particularly high (for example, redo CABG (coronary artery bypass graft surgery), where there is no suitable alternative, and only when the likely benefits outweigh any risks to individual patients.
Aprotinin is indicated for the prevention of major blood loss during coronary artery bypass graft surgery. Since 2006, the safety of aprotinin has been kept under review within Europe due to emerging evidence of adverse effects on the kidney as well as a possible increased risk of heart and cerebral disorders and death. On the basis of the evidence of kidney dysfunction, action was taken within Europe last year to restrict the usage of aprotinin only as a preventative to reduce blood loss in patients undergoing cardiopulmonary bypass in the course of coronary artery bypass graft surgery who are at increased risk of blood loss or blood transfusion. As the evidence of an increased risk of death and heart and cerebral disorders was inconclusive, no further action was taken until more data are available.