The Data Safety Monitoring Board for a trial of 3,000 Canadian surgery patients recommended halting the study after early findings pointed to a greater chance of dying, according to the FDA, which maintains the data support findings from studies previously reviewed by the agency. The re-evaluation may result in the need to revise the labeling or other unspecified regulatory actions. But we can guess.
A year ago, an FDA panel met to review data showing Trasylol was linked to a higher risk of death, kidney failure, congestive heart failure and stroke. The panel declared Trasylol was safe and effective, and voted unanimously to keep the med on the market. But a few days later, the FDA was contacted by a Bayer consultant at Harvardâ€™s School of Public Health, who said Bayer hid evidence. He was hired by Bayer six months earlier to review a 67,000-patient database and compare Trasylol side effects with two other anti-bleeding drugs.
The disclosure caused a furor, especially after it became known that Bayer employees failed to notify the FDA of the study, which showed that Trasylol can increase risk of death, kidney damage, heart failure and stroke. To clear its name, Bayer hired an outside lawyer to investigate. And this summer, prior to the latest FDA panel meeting, the drugmaker insisted the cover-up was no cover-up, but merely a misunderstanding by two employees.
Meanwhile, the drugmaker e-mailed a statement saying that "data will now be collected from all centers throughout Canada and data analysis will be undertaken by those conducting the BART study - a process that is expected to take between four and eight weeks. Consequently no further evaluation either by Bayer or by regulatory authorities can take place until additional information becomes available from the BART investigators."