The US Food and Drug Administration (FDA) announced that, at the agency’s request, Bayer Pharmaceuticals Corporation agreed to a marketing suspension of Trasylol.
The drug is used to control bleeding during heart surgery. It was suspended pending detailed review of preliminary results from a Canadian study that suggested an increased risk for death.
The FDA has requested the suspension in the interest of patient safety based on the serious nature of the outcomes as suggested in the preliminary data.
The FDA has not yet received full study data, but says they expect 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.
Drug being phased out as no alternatives yet available
There are not many treatment options for patients at risk for excessive bleeding during cardiac surgery, which is why the FDA is working with Bayer to faze Trasylol out of the marketplace in a way that does not cause shortages of other drugs used for the same purpose.
Until the FDA has had a chance to 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 will explore ways for those doctors to have continued,albeit, limited access, to Trasylol.
Two weeks ago, the FDA was notified that researchers with the Ottawa Health Institute had 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.
Warning labels already revised
The preliminary data from this terminated study suggested that fewer patients receiving the drug experienced serious bleeding events.
In October the FDA issued a statement about an Ongoing Safety Review of Trasylol in response to the Canadian study’s termination.
Last year the FDA revised the labelling 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.
Heart-surgery drug not safe?