Bayer HealthCare has announced they are discontinuing three clinical trials of the drug Trasylol, citing recent FDA-approved label changes. Bayer was hoping to expand the approved usage of the drug, is currently approved for use in the course of coronary artery bypass graft surgery.
The trials were to investigate the safety and efficacy of Trasylol (aprotinin injection) in adults undergoing spinal-fushion surgery pneumonectomy (lung removal) or esophagectomy (esophagus removal) for cancer and radical total cystectomy (bladder removal) for cancer. The drug is used to help stop blood loss while reducing the need for blood transfusions.
According to the FDA, “The new label specifies Trasylol should not be given to patients that are at an increased risk for blood loss and transfusion in the setting of coronary bypass graft surgery (procedure used to improve blood flow to the heart) when patients undergo cardiopulmonary bypass (a procedure that allows a machine to take over the hearts functions if/when it should stop during surgery). Changes also include a warning that Trasylol increases possible risk for kidney damage, and suggests ways to manage and reduce risk for hypersensitivity reactions.”
The label changes were recommended by the FDA’s Cardiovascular and Renal Drugs Advisory Committee. The review of Trasylol started in January 2006 after a published study reported an increase in the possibility of kidney failure, heart attack and stroke in Trasylol patients compared to patients treated with other drugs, while another study reported increase in possible kidney damage in comparison 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.