Below is the FDA's approval for Trasylol

The Food and Drug Administration today announced approval of aprotinin (Trasylol), a drug that can reduce the need for blood transfusions in patients undergoing heart bypass surgery.

In l991, 265,000 coronary bypass graft operations were performed to replace diseased blood vessels. Excessive bleeding is a frequent complication of this surgery.

Two placebo controlled clinical trials conducted in the United States demonstrated that aprotinin effectively reduced blood loss and decreased the need for transfusions. In one study, 42 percent of patients treated with aprotinin needed at least one unit of blood, compared to 77 percent who did not receive the drug. The second study showed similar results.

Aprotinin was studied for use mainly in heart surgery because the circulation of the blood outside the body in this surgery increases the likelihood of excessive bleeding during and after surgery. Its use should be reserved for high risk patients, however, because severe allergic reactions can result from using it more than once in a patient. Kidney toxicity was also a problem in some patients in the trials.

"Aprotinin can reduce the risks of bypass surgery for some patients," said FDA Commissioner David A. Kessler, M.D. "Fewer transfusions mean a much lower risk of infection or possible adverse reactions to the blood."

Aprotinin will be most useful in patients at high risk of bleeding -- particularly patients undergoing repeat bypass surgery or patients with clotting defects, for example. The drug may also be used in patients with rare blood types or in other cases when access to blood is limited.

Miles Inc. of West Haven, Conn., will market aprotinin under the name Trasylol Injection. The company has agreed to conduct further studies to evaluate the drug in other types of surgery associated with a high risk of bleeding, such as organ transplants and aortic reconstruction.

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see also:

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