Bayer pulls Trasylol off the market at request of FDA

Trasylol manufactured by Bayer AG. Source: KEPR TV

Following a request by the FDA, Bayer on Monday suspended international sales of its anti-bleeding drug, Trasylol, after a clinical trial led by Canadian researchers found the drug was linked to a higher risk of death than alternative medications.

Bayer said that suspension of sales is temporary until the final results from the Blood conservation using Antifibrinolytics in a Randomized Trial (BART) “can be compiled, received and evaluated.”

In its release, the FDA said it “requested the suspension in the interest of patient safety based on the serious nature of the outcomes suggested in the preliminary data.” The agency also said they were waiting to make a final judgment on Trasylol until they received the completed data from the BART trial.

BART was designed to test the efficacy of aprotinin, the generic name for Trasylol, and two related drugs, tranexamic acid and aminocaproic acid. They are used to reduce blood loss during bypass surgery with the aim of minimizing the need for blood transfusions. The Ottawa Health Research Institute conducted the study of approximately 3,000 high-risk cardiac patients undergoing either re-operation for coronary heart bypass graft (CABG), aortic valve replacement or combined valves or valve/CABG procedures.

The FDA recognized that there “are not many treatment options for patients at risk for excessive bleeding during cardiac surgery.” Therefore, the agency said it is working with Bayer to phase Trasylol out of the market in a way that does not cause shortages of other drugs used for the same purpose.

On Oct. 25, 2007, Bayer posted warnings to physicians and healthcare providers regarding the use of Trasylol, in conjunction with the FDA and other international regulatory authorities posting health alerts in their respective markets.

The FDA has said that until officials “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.”

Bayer announced that the year-to-date estimated global revenue for Trasylol was $136 million, including approximately $92 million in the United States.