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 aprotinin |
| Trasylol |
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Pharmaceutical
company:
Bayer Pharmaceuticals
www.bayer.com |
NEW WARNING
The Food and Drug Administration (FDA) issued an alert regarding revised labeling for the systemic hemostatic drug aprotinin (Trasylol). The revised labeling comes from an FDA review of safety information related to the drug which indicated an increased risk of fatal kidney damage, stroke, and heart failure when the drug is used. The revised label limits the use of the drug and states that the drug should only be given to patients who are at increased risk for blood loss and blood transfusion during coronary artery bypass graft (or CABG) surgery when patients require cardiopulmonary bypass. Safety warnings include the risk of kidney damage and suggest ways to manage and reduce the patient’s risk of hypersensitivity reactions.
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