Injured by Trasylol?

Trasylol (generic name aprotinin), Bayer's injectable drug used to prevent excessive blood loss during heart surgery has produced distrubing results in a recent New England Journal of Medicine (NEJM) Study.  According to a recent report by researcher and reported in the New England Journal of Medicine on January 25, 2006, patients who were given Trasylol, compared with controls, had nearly double the risk of death, renal failure, or stroke and a more than 50% increased risk of heart attack. 

According to this article at Med Page Today (link)

"Their observational study involved more than 4,300 patients undergoing coronary-artery bypass surgery with cardiopulmonary bypass at 69 medical institutions worldwide. About 1,300 patients received Trasylol, about 900 received the generic antifibrinolytic drug aminocaproic acid, about 800 received the generic antifibrinolytic drug tranexamic acid, and about 1,300 control patients received no drug to control bleeding.

Data were gathered throughout each patient's hospital stay. Compared with the control groups, patients receiving Trasylol had double the risk of renal failure requiring dialysis (odds ratio=2.34; 95% confidence interval=1.27-4.31). Similarly, Trasylol was associated with a 55% increase in the risk of myocardial infarction or heart failure (OR and 95% CI not given; P<0.001) and a 181% increase in the risk of stroke or encephalopathy (OR and 95% CI not given; P=0.001).

Overall, Trasylol was associated with an increased risk of all-cause death (2.8% versus 1.3% on the control group; P=0.02). Neither aminocaproic acid nor tranexamic acid was associated with an increased risk of renal, cardiac, or cerebral events, the researchers said.  All three agents reduced blood loss to similar extents"

Lower Cost and Safer Alternatives Recommended

Neither the aminocaproic acid or tranexamic acid had the increased risks according to the study.  These generic drugs were confirmed to be safe and effective.  Also there is a significant difference in pricing when comparing Trasylol versus aminocaproic acid (Amicar) or tranexamic acid (Cyklokapron).

Bayer Responds

Bayer put out a statment according to WebWire® regarding the findings saying "The study conclusions published today by Mangano et al. are not consistent with the more than 15 years of clinical trial data and experience Bayer has amassed on Trasylol."  But the study's authors including Dennis Mangano of the Ischemia Research and Education Foundation said in the study that their "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."

On November 5, 2007 Trasylol was removed from the market pending furhter clinical trials and test results.

Legal Help for Trasylol Victims

If you have had heart surgery and subsequently had to go on dialysis because of a kidney injury, this may be attributable to having received Aprotinin which is sold under the brand name Trasylol.  If so, you may have a cause of action against Bayer, the manufacturer of the drug.  Our firm has settled in excess of $1 billion on behalf of victims of drug related injuries. 

If you want someone from our office to review your case fill out our contact form or call toll free 888-222-7052 today.