The Canadian trial for the drug manufactured by Bayer AG had to be stopped early due to an increase in deaths for cardiac surgery patients placed on the drug. The trial was to include 3,000 patients.
Preliminary results from that trial also suggested Trasylol, which works by blocking enzymes that dissolve blood clots, increased the risk of death when compared with the other drugs.
Also known as aprotinin, Trasylol was first approved by the FDA in 1993 to limit blood loss in patients undergoing cardiac surgery.
Issuing a new guidance to doctors on Thursday, Bayer said "that physicians use Trasylol only in accordance with approved product labeling."
The German manufacturer of the drug said it believes the drug "remains a safe and effective treatment option for physicians," but it is working with the FDA and international health authorities to see if any labels are needed.
The FDA indicated such changes, including unspecified regulatory actions, may be possible. Earlier this month, FDA advisers recommended Trasylol remain on the market despite its links to an increased risk of death and other serious side effects, the AP reports.
The drug's safety was re-evaluated in January 2006 after two studies linked the drug's use to serious side effects, including kidney problems, heart attacks and strokes.
