Alert issued for CABG blood loss drug

February 13, 2006

The FDA has issued a public health advisory for aprotinin injection (Trasylol, Bayer), a drug used to prevent blood loss during coronary artery bypass graft (CABG) surgery, after it was linked to a higher risk of serious side effects, including kidney problems, heart attacks, and strokes, in two different studies. The agency said it is evaluating the potential risks to determine whether there is a need for further action and plans to convene an advisory committee this year to discuss the existing data. In the meantime, the FDA recommends that healthcare providers carefully monitor patients receiving the drug for the occurrence of toxicity to the kidneys, heart, or central nervous system and report any findings to the drug manufacturer or the FDA Medwatch program.

Alert issued for CABG blood loss drug

The FDA has issued a public health advisory for aprotinin injection (Trasylol, Bayer), a drug used to prevent blood loss during coronary artery bypass graft (CABG) surgery, after it was linked to a higher risk of serious side effects, including kidney problems, heart attacks, and strokes, in two different studies. The agency said it is evaluating the potential risks to determine whether there is a need for further action and plans to convene an advisory committee this year to discuss the existing data. In the meantime, the FDA recommends that healthcare providers carefully monitor patients receiving the drug for the occurrence of toxicity to the kidneys, heart, or central nervous system and report any findings to the drug manufacturer or the FDA Medwatch program. Physicians should consider limiting the use of aprotinin to those situations where the benefit of reduced blood loss outweighs the risk, and patients should discuss the risks of the surgery with their physician, including ways to minimize the risk for bleeding.

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