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FDA Approves New Warning for Bayer Drug

Dec 15, 2006 | AP

Government health officials said Friday they have approved a new label for Bayer's Trasylol that highlights the possible risk of kidney damage associated with taking the drug.

More than 600,000 people worldwide were treated with the drug in 2005, according to Bayer, which collected $291 million in sales from Trasylol. Annual revenue for the company was $34.7 billion in 2005.

Trasylol is the only drug approved by the FDA to reduce blood loss during coronary artery bypass surgery. The new label states that the drug should only be used on patients who are at an increased risk for blood loss and blood transfusion during the surgical procedure.

FDA began reassessing the safety of the drug earlier this year, when two separate studies suggested the drug was linked to heart attack, stroke and kidney problems. In September, Bayer submitted new data to the FDA about risks of Trasylol, days after a public hearing was held to review the drug's labeling. The company said it should have disclosed the results earlier and suspended two senior staff members as a result of the incident.

A Bayer spokesman said the company is still investigating why the results were witheld.

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