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news.An FDA advisory panel has endorsed the use of Bayer AG's Trasylol, a drug for controlling bleeding during surgery, following fears that it could be linked to heart attacks, strokes, kidney damage and allergic reactions.
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The US advisory committee said that Trasylol was safe and effective. Trasylol is used in coronary artery bypass graft surgery patients.
Earlier in the year, the FDA had advised limited use of Trasydol whilst the agency evaluated two studies linking the drug to kidney problems and heart conditions. The studies also claimed 51 people had allergic reactions as a result of taking Trasylol.
Many FDA members raised questions about the research and said they didn't consider the kidney-failure risk as high as one of the studies suggested.
Additionally Bayer has begun discussions with the FDA regarding possible updates to the US Trasylol label. Changes could include a specific indication that Trasylol should be used in patients at increased risk for blood loss and revised guides to indicate some that he drug temporarily raises creatinine levels in some patients.
Bayer said the company would continue to work closely with the FDA and other regulatory authorities regarding changes to the Trasylol label.