Trasylol already carries a "black box" on its labeling, which warns doctors that it can cause kidney problems.

FORBES: Bayer's Big Mistake

Or at Bayer, which will face another FDA panel about the risks of it heart surgery drug Trasylol Wednesday.

FORBES: Magazine Article

In a prepared statement, Bayer said that it remains committed to patient safety and to evaluating the safety and efficacy of Trasylol.

FORBES: Magazine Article

On Sept. 21, the FDA's panel of medical experts met to consider that data and voted 18 to 0 that Trasylol did not need new safety labeling.

FORBES: Bayer's Big Mistake

According to a Public Health Advisory from the FDA, the new study linked Trasylol to increased risk of death, serious kidney damage, congestive heart failure and strokes.

FORBES: Bayer's Big Mistake

Or at Bayer (nyse: BAY - news - people ), which will face another FDA panel about the risks of it heart surgery drug Trasylol Wednesday.

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This year, the company has faced controversy over its drug Trasylol, used in heart surgery, which a study in The New England Journal of Medicine said may pose significant risks to patients.

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Bayer said in a statement that it "mistakenly" did not tell the FDA about the evaluation of 67, 000 hospital records regarding the drug Trasylol, which is used to prevent bleeding during open-heart surgery.

FORBES: Magazine Article

Bayer (nyse: BAY - news - people ) said in a statement that it "mistakenly" did not tell the FDA about the evaluation of 67, 000 hospital records regarding the drug Trasylol, which is used to prevent bleeding during open-heart surgery.

FORBES: Bayer's Big Mistake