Trasylol and Kidney Failure

Our law firm has been contacted by patients who suffered kidney failure after being administered Trasylol. We are currently representing a number of people in cases involving kidney failure and have extensive experience in this area.

We are available to represent patients and their families in Trasylol kidney failure cases. Lawyer Fred Pritzker is lead attorney for these cases. Please contact Fred if you or a loved one experienced the following:

Had no previous history or findings associated with kidney problems
Received Trasylol
Shortly thereafter were found to have kidney damage
Now have permanent kidney damage

Several patients may have died due to Trasylol kidney failure. In those cases, we would represent the family of the patient and seek compensation for their loss. To contact Fred Pritzker, please call (toll free at 1-888-377-8900) or email Fred for a free consultation about your case and a possible Trasylol lawsuit.

Trasylol Kidney Failure (Aprotinin Kidney Failure): Study Monitored Heart Bypass Patients Given Trasylol (Aprotinin)

Trasylol, an aprotinin injection given to patients after bypass surgery, may be responsible for increased risk of kidney failure. An article in the January 2006 issue of the New England Journal of Medicine reported on a study of 4374 heart bypass patients. 1,295 of these were administered Trasylol (aprotinin). The study found that the patients who received Trasylol (aprotinin) had significant, adverse health consequences, including the following:

A greater death rate than the other patients in the study who were not given Trasylol (aprotinin)
Double the risk of kidney failure (renal failure) requiring dialysis
48% increase in the risk of myocardial infarction (heart attack)
109% increase in the risk of heart failure
181% increase in the risk of stroke

The study also found evidence of multi-organ damage involving the heart, brain, and kidneys. the findings of this and other Trasylol research has prompted the FDA to suspend marketing of Trasylol. This is essentially a Trasylol recall.

The article discusses the relationship between Trasylol and kidney damage:

After free glomerular passage, aprotinin binds selectively to the brush border of the proximal tubule membrane, and then, by pinocytosis, it enters into and accumulates within the cytoplasm, inhibiting tubule protease secretion (kallikrein and, secondarily, kinin), prostaglandin and renin synthesis, prostasin secretion, and bradykinin release. Under normothermic ischemia, hypothermia, and other states of high kallikrein activity, these untoward tubular effects are magnified and are complicated by dose-dependent renal afferent vasoconstriction; deep cortical and medullary perfusion and its autoregulation are thereby impaired, and focal tubular necrosis ensues. Furthermore, because of its interference with the synthesis and release of endothelial nitric acid, aprotinin also may instigate macrovascular or microvascular thrombosis.

. . . Rreview of this evidence suggests the presence of several renal "safety signals," including aprotinin-associated alpha1-microglobulin production, tubule-cell deposition of protein bands and proteinuria, dose-dependent increases in creatinine, renal dysfunction, and platelet-fibrin thrombotic occlusions of the renal arterioles after death.

Our data from approximately 1300 aprotinin-treated patients as compared with about 1300 control patients, then, clearly give credence to early concerns stemming from findings in animal models and preliminary findings in patients — namely, that aprotinin is associated with severe renal adverse events and that this association is dose-dependent. The lysine analogues, in contrast, are excreted nearly intact within 24 hours after intravenous administration, with their renal clearance approximating creatinine clearance. Moreover, few reports document an association between these agents and renal dysfunction — a renal-safety profile validated by our results.

The chief author of this study was quoted as saying that up to 1000 lives per month were lost as a result of this drug.

A study published in 2005 in the European Journal of Aaesthesiology (below) found a correlation between aproptinin (Trasylol is an aprotinin injection) and alpha 1 –microglobulin excretion, which can be indicative of renal (kidney) damage. Both patients given low doses of aprotinin and high doses of aprotinin had “significantly higher” alpha 1 –microglobulin excretion during cardiopulmonary bypass. It still remained higher in the group of patients given high doses of aprotinin after 24 hours. The authors of the study concluded that aprotinin may cause greater “renal tubular overload.”

References:

1. Mangano DT, Tudor IC, Dietzel C, The Risk Associated with Aprotinin in Cardiac Surgery, N Engl J Med 354:353, January 26, 2006.

2. Faulí A, Gomar C, Campistol JM, Alvarez L, Manig AM, Matute P., Kidney-specific proteins in patients receiving aprotinin at high- and low-dose regimens during coronary artery bypass graft with cardiopulmonary bypass. European Journal of Aaesthesiology, 22(9):666-71, September 2005.

If you need a Trasylol lawyer for a Trasylol lawsuit, contact us.

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