Trasylol Recall
On November 5, 2007 the Food and Drug Administration (FDA) announced that Bayer Pharmaceuticals Corp. has suspended the sale of Trasylol. Recall of this controversial drug at the request of the FDA was based on preliminary data from a Canadian study that compared heart surgery drugs used to prevent excessive bleeding.
The Blood conservation using antifibrinolytics: A randomized trial in a cardiac surgery population (BART) study was halted on October 19, 2007 due to the increased mortality in patients in the aprotinin (Trasylol) treatment group. The other anti-bleeding drugs in the study, aminocaproicacid and tranexamic acid, did not have the same increased risk of death compared to aprotinin. The study had planned to enroll around 3,000 adult Canadian patients who were going to have various types of cardiac surgery that put them in a high risk category for bleeding.
The FDA began taking a closer look at the safety of Trasylol in January 2006 after the publication of studies that linked the drug to dangerous side effects including heart attacks, kidney problems and strokes. In light of the initial BART study information, the FDA anticipates re-evaluating the risks and benefits of Trasylol. The FDA is working with Bayer to carefully phase Trasyol out of the marketplace in an attempt to prevent shortages of other drugs used prevent excessive bleeding during cardiac surgery.
