TRASYLOL TIMELINE
January 2006: Two studies published showing increased risk of kidney failure, kidney damage, heart attack and stroke associated with Trasylol.
February 8, 2006: FDA issues Public Health Advisory (PHA).
September 2006: Bayer told FDA about more study results showing increased risk of death, congestive heart failure and stroke.
December 15, 2006: Labels revised to add warning and to limit approved Trasylol use to patients at high risk for blood loss and blood transfusion during coronary bypass graft surgery.
October 2007: A Canadian study (BART study) was stopped because of deaths possibly associated with Trasylol. FDA issued Preliminary Statement saying that because of the terminated study, they would re-evaluate the risks and benefits of Trasylol.
November 5, 2007: At FDA's request, Bayer temporarily suspended marketing of Trasylol pending a detailed review of the Canadian study.
May 14, 2008: Bayer announced that it is removing all remaining Trasylol stock from the U.S. market. Most of it is in warehouses, and hospital's and doctor's stock. Trasylol will no longer be available for regular use in the U.S. It will only be available for limited, investigational use. See the following excerpt from the FDA Press Release:
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.
FDA limits access to certain drugs to patients with serious or immediately life threatening disease or conditions who lack other therapeutic options and may benefit from such therapies. This type of access requires the submission of a protocol, which is reviewed and approved by the agency. Bayer has agreed to provide Trasylol through this mechanism for the limited use described above.
This comes following the publication of the Canadian study results (BART) - 250Kb in The New England Journal of Medicine on May 14, 2008. The results suggest that Trasylol causes an increased risk of death when compared to the other two drugs in the study.
