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The Food and Drug Administration has issued a formal Public Health Advisory to doctors regarding the serious side effects associated with the heart surgery medication Trasylol. Trasylol is used by heart surgeons for the prevention of excessive blood loss in patients undergoing artery bypass surgery and other cardiovascular procedures. Recent studies however have shown that taking Trasylol during heart surgery bears a substantially heightened risk for heart attack, renal failure, and strokes, in comparison with other antifibrinolytic medications.

In a statement from the FDA, director of the FDA''s Center for Drug Evaluation and Research center, Dr. Steven Galson commented, “We''re working to evaluate the potential risks and determine whether there is need for further action. In the meantime, we advise providers to carefully assess the benefits and risks of the drug for their patients.”

The FDA however, is recommending several precautions to take until further research can be achieved.

•  Doctors should be wary of signs suggesting toxic effects of the drug. For instance, watching patients closely for adverse side effects to the kidneys, heart or central nervous system.

•  Trasylol should be limited to use in patients where the benefit outweighs the risks.

•  Doctors should discuss all serious risks as well as alternative medications with the patient prior to administering Trasylol.

Trasylol is thus far the only FDA approved medication to control blood loss in surgery, however, there are generic options available such as aminocaproic acid and tranexamic acid that do not present the same risks or cost and are comparably effective. A recent study published in the New England Journal of Medicine showed that patients taking Trasylol, in comparison with those taking other medications or no medication, exhibited a significantly higher risk for kidney problems, heart complications, and strokes. However, the study may have small discrepancies since doctors and patients involved used their own discretion to determine which patients should take the medication. Doctors may have prescribed Trasylol to patients who were in a more critical condition in the first place.

The FDA is considering the creation of an advisory committee this coming year to evaluate the risks and benefits associated with Trasylol. This committee would determine if additional safety measures should be taken and if so, what they will be.