• Defective Drug Side Effects

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A drug commonly administered during heart surgery to control bleeding is now causing reason for serious concern among patients and medical professionals. Trasylol (aprotinin), which was approved for use by the FDA in 1993, has shown to substantially increase the risk of adverse side effects such as death, renal failure, strokes, and most commonly, heart attacks.

The observational study, which was conducted by the Ischemia Research and Education Foundation, examined 4,300 patients who were undergoing coronary-artery bypass surgery. The study, which spanned throughout 69 various medical facilities, found alarming results of the risks associated with Trasylol.

Patients who were given the drug, in comparison with others who were given generic antifibrinolytic medications, experienced a significantly higher risk of renal failure, heart failure and most alarmingly, a 181 percent increased risk of strokes and encephalopathy. Over all, the risk of death was increased to 2.8 % with the usage of Trasylol in comparison with 1.3 % with other generic antifibrinolytic drugs.

Dr. Mangano of the Ischemia Research and Education Foundation claims that the FDA safety trials for the drug were simply not adequate at detecting the risk factor. “Some surgeons and anesthesiologists who use the drug have been concerned about its potential risks since it was first approved for clinical use; yet until the report by Mangana et al., sufficient data have not been available for an analysis of the risks and benefits of aprotinin,” comment Dr. Gus Vlahakes of Harvard Medical School and Massachusetts General Hospital.

Efforts to determine safe usage of Trasylol are underway, however, until then, “findings indicate that reconsideration of the safety of aprotinin among patients undergoing cardiac surgery is warranted and indicate replacement of aprotinin with either aminocaproic acid or tranexamic acid,” the researchers concluded.