Bayer halts Trasylol studies
Bayer discontinued three Trasylol clinical studies which were set up to look at expanding the use of the drug. Trasylol is currently approved to help reduce blood loss in bypass heart surgery patients who are at a high risk of excessive bleeding and blood transfusion.
The clinical trials for Trasylol were set up to explore the safety and efficacy of Trasylol in areas such as spinal-fusion surgery, pneumonectomy, esophagectomy for cancer, and total cystectomy for cancer.
Bayer stated they halted the studies following an FDA Trasylol labeling change that Trasylol should only be used in certain surgical procedures with patients who are at an increased risk for blood loss and blood transfusion and where cardiopulmonary bypass is available. Bayer maintains that the Trasylol studies were not terminated for safety reasons.
According to Dr. Steven Galson, the Director of FDA's Center for Drug Evaluation and Research, "The purpose of the label change is to inform physicians and patients about the risks associated with Trasylol and to ensure they understand the new warnings and use the product as directed by the label."
The clinical trials for Trasylol were set up to explore the safety and efficacy of Trasylol in areas such as spinal-fusion surgery, pneumonectomy, esophagectomy for cancer, and total cystectomy for cancer.
Bayer stated they halted the studies following an FDA Trasylol labeling change that Trasylol should only be used in certain surgical procedures with patients who are at an increased risk for blood loss and blood transfusion and where cardiopulmonary bypass is available. Bayer maintains that the Trasylol studies were not terminated for safety reasons.
According to Dr. Steven Galson, the Director of FDA's Center for Drug Evaluation and Research, "The purpose of the label change is to inform physicians and patients about the risks associated with Trasylol and to ensure they understand the new warnings and use the product as directed by the label."
