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FDA Adds 'Black Box' Warning to Trasylol

Cardiovascular, kidney risks mean Trasylol should only be used in special circumstances

FRIDAY, Dec. 15 (HealthDay News) -- The U.S. Food and Drug Administration has added a stronger "black box" warning on labeling for Trasylol (aprotinin injection) because the drug has been associated with serious kidney damage and an increased risk for death, congestive heart failure and stroke. The FDA is also limiting Trasylol's approved use to specific situations.

The new labeling specifies that Trasylol should only be given to patients who are at an increased risk for blood loss and blood transfusion while undergoing coronary bypass graft surgery or when patients are put on a heart/lung machine during surgery. Use of the drug is contraindicated in patients with a known or suspected previous Trasylol exposure during the past 12 months.

Trasylol, which is derived from the lung tissue of cattle and marketed by Bayer Pharmaceuticals, was first approved by the FDA in 1993.

"Now the black box warning states that Trasylol should be administered only in an operative setting where cardiopulmonary bypass can be rapidly initiated," said Dwaine Rieves, M.D., FDA's deputy director of the Division of Medical Imaging and Hematology Products Center for Drug Evaluation and Research. "We are also narrowing the indicated patient population."

In addition, there is a new adverse reaction section on the label that is based on Bayer's review of its global database, Rieves noted. "There is also an alteration of the dosage and administration section to carry over the emphasis on the risk for renal dysfunction and to more clearly describe the dose-administration procedures," he said.

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