Bayer suspends sales of Trasylol at request of FDA and Health Canada.Bayer today (Nov. 5) agreed to requests by FDA FDA
Food and Drug Administration
n.pr See Food and Drug Administration.
n.pr the abbreviation for the Food and Drug Administration. to suspend the marketing 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.
Bayer also today suspended marketing of Trasylol in Canada at the request of Health Canada's equivalent of FDA.
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 The Ottawa Health Research Institute (OHRI) is a non-profit academic health research institute located in Canada’s capital city of Ottawa. The OHRI’s mission is to excel in research, education and innovative patient care. , and other regulatory agencies to undertake a thorough analysis of data to better understand the risks and benefits of Trasylol.
The BART study--Blood Conservation using Anti-fibrinolytics: A Randomized ran·dom·ize
tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es
To make random in arrangement, especially in order to control the variables in an experiment. Trial in High-Risk Cardiac Surgery Patients--is a multi-institutional, blinded, randomized controlled trial A randomized controlled trial (RCT) is a scientific procedure most commonly used in testing medicines or medical procedures. RCTs are considered the most reliable form of scientific evidence because it eliminates all forms of spurious causality. to compare the efficacy and safety of the use of Trasylol (aprotinin aprotinin /apro·ti·nin/ (ap?ro-ti´nin) an inhibitor of proteolytic enzymes used to reduce perioperative blood loss in patients undergoing cardiopulmonary bypass during coronary artery bypass graft. ), aminocaproic acid aminocaproic acid (mē´nōk and tranexamic acid tranexamic acid /tran·ex·am·ic ac·id/ (tran?ek-sam´ik) an antifibrinolytic that competitively inhibits activation of plasminogen; used as a hemostatic in the prophylaxis and treatment of severe hemorrhage associated with excessive in approximately 3000 high-risk cardiac surgical patients undergoing either re-operation for coronary heart bypass graft bypass graft Surgery A surrogate blood vessel used to reroute blood; BGs may be synthetic–Dacron, or autologous–vein from the Pt's own leg, to substitute for diseased vessel (CABG CABG coronary artery bypass graft.
coronary artery bypass graft
CABG Coronary artery bypass graft, see there ) or aortic valve replacement Aortic valve replacement is a cardiac surgery procedure in which a patient's aortic valve is replaced by a different valve. The aortic valve can be affected by a range of diseases; the valve can either become leaky (aortic insufficiency / regurgitation) or partially blocked (aortic , or combined valves or valve/CABG procedures.
The BART data safety monitoring board (DSMB DSMB Data & Safety Monitoring Board Clinical research A committee of independent clinical research experts who review data in ongoing clinical trials, ensuring that participants are not exposed to undue risk, and look for any differences in effectiveness ) notified the trials' executive committee two weeks ago that an interim analysis indicated that Trasylol treatment appeared to reduce bleeding, but an increase in all-cause mortality almost reached conventional statistical significance for 30-day mortality for patients in the Trasylol treatment arm compared to patients who received either aminocaproic acid or tranexamic acid.
Bayer immediately informed FDA, Health Canada and other health authorities around the world.
On Oct. 26, FDA issued an Early Communication about an Ongoing Safety Review of Trasylol in response to the Canadian study's termination. In 2006, FDA revised the labeling 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.
Data will now be collected from all centers throughout Canada and data analysis will be undertaken by those conducting the BART study--a process that is expected to take between four and eight weeks. No further evaluation either by regulatory authorities or the company can take place until additional information becomes available from the BART investigators.
Because treatment options for patients at risk for excessive bleeding during cardiac surgery are limited, 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," the agency said in a statement announcing the marketing suspension. Anti-fibrinolytic drugs help slow the breakdown of blood clots and subsequent excessive bleeding. "The preliminary data from this terminated study also suggested that fewer patients receiving the drug experienced serious bleeding events," FDA noted.
"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 agency added.
Bayer "believes Trasylol remains a safe and effective treatment option for physicians. Bayer will continue to work closely with medical experts, the FDA and health authorities in countries where Trasylol is marketed to reevaluate the overall risk-benefit of the product and will evaluate the need for a label change and/or other actions as additional data and analyses become available from the BART trial," the company announced in a statement.
Bayer has posted information regarding this issue on its websites www.trasylol.com, www.pharma.bayer.com, www.bayerhealthcare.com/trasylol/en.
For information on the BART study, visit: www.ohri.ca/programs/clinical_epidemiology/thrombosi s_group/studies/BART.asp