Bayer HealthCare announced it is discontinuing three clinical trials for their drug, Trasylol, citing recent FDA-approved label changes. Bayer was hoping to expand the approved usage of the drug, which currently is only approved for use in the course of coronary artery bypass graft surgery.
The trials were set up to investigate the safety and efficacy of Trasylol (aprotinin injection) in adults undergoing spinal-fusion surgery, pneumonectomy (removal of lung) or esophagectomy (removal of esophagus) for cancer, and radical or total cystectomy (removal of bladder) for cancer. The drug is intended to help stop blood loss and reduce the need for blood transfusions.
According to the FDA, Ã¢â‚¬Å“The new labeling specifies that Trasylol should only be given to patients who are at an increased risk for blood loss and blood transfusion in the setting of coronary bypass graft surgery (a procedure used to improve blood flow to the heart) when patients undergo cardiopulmonary bypass (a procedure that allows a machine to take over the heart’s functions when it is stopped during surgery). The changes also include a warning that Trasylol increases the possible risk for kidney damage, and suggests ways to manage and reduce the patientÃ¢â‚¬â„¢s risk for hypersensitivity (exaggerated immune) reactions.Ã¢â‚¬Â
The changes to the labeling were based on recommendations from the FDAÃ¢â‚¬â„¢s Cardiovascular and Renal Drugs Advisory Committee. The agencyÃ¢â‚¬â„¢s safety review of Trasylol began in January 2006 after one published study reported an increase in the possibility of kidney failure, heart attack, and stroke in Trasylol patients compared to those treated with other drugs, while a second study reported an increase in the possibility of kidney damage compared to other drugs.
On September 27, 2006 a week after the FDA held a public meeting of the Cardiovascular and Renal Drugs Advisory Committee to discuss the safety and risk-benefit profile for Trasylol–Bayer admitted to having conducted an additional internal study, which found that, in addition to severe kidney damage, Trasylol may increase the chance for death, congestive heart failure, and strokes. After further FDA review, additional changes to the labeling may be forthcoming.
Bayer stresses that the recent clinical trials were not halted for safety reasons.