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Editor: Jamie Sheller
Profession: Trasylol Attorney

Category: Trasylol Discussion

A study published in the February 2007 edition of the Journal of the American Medical Association (JAMA) showed an increased risk of using the recalled drug Trasylol that continued for at least five years after surgery. The study analyzed data from 4374 patients. The researchers were calculating the survival rate of patients at six weeks, six months, and every year for five years.

During 5 years, 223 deaths occurred among 1072 aprotinin-treated patients (20.8%), a death rate nearly two-thirds greater than control patients (128 deaths among 1009 patients, 12.7%; covariate adjusted hazard ratio [without propensity adjustment], 1.48; 95% CI, 1.19-1.85; P<.001). Rates were similar for aminocaproic acid patients (132 deaths among 834 patients, 15.8%; adjusted hazard ratio, 1.03; 95% CI, 0.80-1.33; P = .81) and for tranexamic acid patients (65 deaths among 442 patients, 14.7%; adjusted hazard ratio, 1.07; 95% CI, 0.80-1.45; P = .64). Covariate-adjusted survival analyses demonstrated significant association with death for aprotinin, but not for either aminocaproic or tranexamic acid (Figure 2)--the latter 2 biochemically similar lysine analogs having nearly indistinguishable mortality (survival) patterns despite disparate use and approval among countries and centers. Aprotinin's association with mortality persisted among patients who survived their index hospitalization (Figure 2). Proportional hazards analysis using multiple covariates confirmed the survival associations (Table 2, Table 3).

The study concluded that the risk of the drug was too high to continue use and that there were alternative drugs that could be used. Trasylol was not pulled from the market until November of this year, a full eight months after the JAMA study was released.