Bayer AG of Germany, agreed to temporarily suspend sales of Trasylol last November following requests from the Food and Drug Administration (FDA). The antibleeding drug may have received its final blow with a new study that shows it is associated with a greater risk of death compared to competing medications.
The results of that study, published by the New England Journal of Medicine, confirmed the earlier findings: a more than 50% increase in the relative risk of death. The study found that 6% of patients who received Trasylol, or aprotinin, died within 30 days of surgery compared to 4% of patients who received tranexamic acid or aminocaproic acid. All three drugs are used to prevent blood loss during heart surgery.
What was the best comment about the drug and the tests results? “This study could have been done by the company five to ten years ago,” Dr. Paul Hébert said, adding that Trasylol costs about $1,400 compared to about $4 for aminocaproic acid. Dr. Hebert was one of the studies lead investigators.
83 patients have filed lawsuits against Bayer over the use of the drug. And if President George Bush has his way…those lawsuits would be banned because the FDA initially approved the drug.
Doesn’t seem fair does it?