Bayer Stops Worldwide Sales of Trasylol Pending Safety Data
Bayer is suspending global marketing of its clotting drug Trasylol as the FDA waits for additional data suggesting the clotting drug was associated with an increased risk of death.
Enrollment in the Canadian Blood Conservation using Anti-fibrinolytics: A Randomized Trial in High-Risk Cardiac Surgery Patients (BART) study was halted after a safety monitoring board observed an increased risk of all-cause mortality in patients receiving Trasylol (aprotinin) compared with the control arms.
The FDA requested the marketing suspension once it learned additional information from the study might not reach the agency for six weeks or longer, Office of New Drugs Director John Jenkins said. The FDA will remove products from the marketplace gradually to avoid shortages of the few alternative drugs used to limit blood loss during coronary artery bypass surgery.
The German Federal Institute for Drugs and Medical Devices also requested Bayer temporarily suspend Trasylol marketing in Germany until the final BART data is available. Jenkins said the FDA made its request independent of the German agency and other regulatory agencies.
Bayer has defended the drug, saying the total available data support a favorable risk-benefit profile for Trasylol.
More information on the marketing suspension can be seen at www.fda.gov/bbs/topics/NEWS/2007/NEW