Bayer suspends sales of Trasylol at request of FDA and Health Canada.

Bayer today (Nov. 5) agreed to requests by FDA 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, 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 Trial in High-Risk Cardiac Surgery Patients--is a multi-institutional, blinded, randomized controlled trial to compare the efficacy and safety of the use of Trasylol (aprotinin), aminocaproic acid and tranexamic acid in approximately 3000 high-risk cardiac surgical patients undergoing either re-operation for coronary heart bypass graft (CABG) or aortic valve replacement, or combined valves or valve/CABG procedures.

The BART data safety monitoring board (DSMB) 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