Today the FDA announced that at their request Bayer Pharmaceuticals Corp. has agreed to immediately cease all marketing associated with Trasylol. This comes as a follow up to a report from October 26 that suggested that their may be an increased risk of death connected to the drug used to control bleeding during heart surgery. The preliminary results of a Canadians study on Trasylol suggest this increased risk but the FDA says their needs to be more analysis preformed before anything can be concluded for certain.
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.
The study was terminated after preliminary result began to show this increased risk of death and until the FDA has a chance to review all of the data from the terminated study it will be very difficult to know whether the benefits outweigh the risks of the drug. There are very few options for people at risk from excessive bleeding during surgery so the FDA is attempting to still allow limited access to the drug.
For more information on this subject, please refer to the section on Drugs, Medical Devices, and Implants.