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Trasylol Gets Black Box Warning

The U.S. Food and Drug Administration on Friday slapped a stronger black box warning on labeling for Trasylol, an injection drug given to patients before undergoing heart surgery to limit bleeding and the need for transfusions.

Because use of the medication has been associated with serious kidney damage and an increased risk of death, congestive heart failure, and strokes, the FDA is also limiting its approved use.

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