Bayer HealthCare Pharmaceuticals has notified the FDA that the company has begun removal of remaining Trasylol from the U.S. market, which includes mostly hospitals, warehouse or physician’s stock. Bayer and the FDA are working together to ensure a smooth transition.
Under a limited use agreement, Trayslol is limited to investigational use of the drug according to the procedures outlined in a special treatment protocol which allows for certain patients who are at increased risk of blood loss during coronary artery bypass graft surgery and have no other alternative therapy options. Doctors who use this option must also verify that the benefits clearly outweigh the risk to their patient.
The FDA limits access to certain drugs, such as Trasylol, to patients with serious or life threatening disease or conditions who lack other medical options who may benefit from such therapies. This type of access requires the submission of protocol which is then reviewed and approved by the agency. Bayer has agreed to provide Traysylol the limited use above.
Trasylol Background: On November 5, 2007 the U.S. Food and Drug Administration announced that Bayer agreed to an FDA-requested marketing suspension of Trasylol, a drug to control bleeding during heart procedures. At that time, preliminary results from a Canadian study suggested increased risk of death compared to two other drugs used for the same purpose included in the study.