FDA Reiterates Trasylol Warning

Armen Hareyan's picture
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Bayer Admits Drug Data Mistake

The Food and Drug Administration is evaluating new data on Trasylol from a study that maker Bayer AG (BAY) "mistakenly" failed to provide earlier.

The agency also reiterated a warning to doctors it issued in February.

In January, data from two publications indicated the drug, which is used to control bleeding, might increase the risk of kidney failure as well as heart attack and stroke in patients undergoing coronary artery bypass graft surgery.

Bayer said it "mistakenly" didn't inform the FDA about the study, describing the study's data as preliminary with questions about the study population, outcomes and methodology.

Despite the data being preliminary, Bayer added it should have shared the data before a Sept. 21 meeting meant to assess the drug's safety.

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"This was a mistake on the company's part," it said in a statement.

As in February, the FDA said Friday physicians should watch for signs of toxicity, particularly to the kidneys, heart, or central nervous system.

The agency also requested doctors report adverse events to Bayer or the FDA.

The FDA advised doctors to "limit Trasylol use to those patients in whom the clinical benefit of reduced blood outweighs these potential risks."

Trasylol, known generically as aprotinin, was approved by the FDA in 1993 for use during surgery to bypass clogged heart arteries.

The company is studying it for use in other settings such as spinal fusion surgery.

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