The FDA ( Food and Drug Administration ) has approved revised labeling for Trasylol ( Aprotinin injection ) to strengthen its safety warnings and to limit its approved usage to specific situations.

Trasylol is given to patients before heart surgery to reduce bleeding and the need for blood transfusions.

The new labeling specifies that Trasylol should only be given to patients who are at an increased risk for blood loss and blood transfusion in the setting of coronary bypass graft surgery when patients undergo cardiopulmonary bypass. The changes also include a warning that Trasylol increases the possible risk for kidney damage, and suggest ways to manage and reduce the patient's risk for hypersensitivity reactions.

The labeling changes follow an FDA-conducted review of safety information that FDA became aware of after the product was introduced to the market.
FDA began this safety review of Trasylol in January 2006.
The review was triggered by the results of two published research studies.

One study reported an increase in the possibility of kidney failure, myocardial infarction and stroke in patients treated with Trasylol compared to those treated with other drugs. The other study reported an increase in the possibility of kidney damage compared to other drugs, but did not show an increased risk of heart attack or stroke.

On February 8, 2006, FDA issued a Public Health Advisory regarding these new findings with Trasylol.
On September 21, 2006, FDA held a public meeting of the Cardiovascular and Renal Drugs Advisory Committee to discuss the safety and overall risk-benefit profile for Trasylol. At that meeting, the committee discussed the findings from the two published observational studies, a Bayer worldwide safety review, and the FDA review of its own post-marketing database, and made recommendations for labeling changes.
The labeling changes for Trasylol are based upon the recommendations of that advisory committee.

FDA announced on September 29, 2006, that Bayer informed the agency of an additional safety study on September 27, 2006. The preliminary results from that study suggest that in addition to serous kidney damage, Trasylol may increase the chance for death, congestive heart failure, and strokes. The FDA review of this additional Trasylol safety information is continuing and it may result in other actions, including additional changes to the labeling.

Source: FDA, 2006


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