Read about why the FDA announced on November 5, 2007, that Bayer Pharmaceuticals Corp. will cease the marketing and sale of Trasylol. Learn about Trasylol Lawsuits from Trasylol Lawyers.

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The incidence of kidney damage associated with coronary artery bypass surgery in the United States has increased significantly over the past 16 years, but the rate of death from such damage has decreased significantly during the period.
In an analysis of more than 5 million discharges from hospitals across the United States, researchers at Duke University Medical Center found that the incidence of acute renal failure associated with coronary artery bypass surgery increased almost five-fold during the study period. The researchers estimate that approximately 20,000 cases of the disorder occurs nationwide each year.
The rate of death from acute renal failure caused by bypass surgery dropped almost three-fold during the study period. Patients with the disorder tend to have higher death rates, and also to require longer hospital stays, than patients who do not experience kidney damage after surgery.
Findings suggest that current strategies used to prevent acute renal failure following bypass surgery may not be as effective as previously thought. Postoperative acute renal failure remains a serious complication of bypass surgery that does not seem to have been
influenced by any strategies designed to prevent it.
More than 467,000 bypass procedures are performed each year in the United States.
Most cases of kidney injury after bypass surgery are transient and cause no serious damage. But up to 2 percent of affected patients will require kidney dialysis, and 60 percent of those patients will die before hospital discharge.
The team’s analysis was not designed to uncover the reasons for the observed rise in incidence of acute renal failure. But the researchers speculate that it may be due, in part, to the growing use of an expanded definition of acute renal failure.
Source: http://anesthesia.mc.duke.edu/news/kid-damage.htm

Women with coronary symptoms are less likely to receive cardiac catheterization or revascularization. Why? Perhaps there is a doctor bias or that women receive less testing and because of personal preference.
During a visit, women were less likely to receive a cardiac evaluation. With regard to test preference, women and men were equally likely to prefer a stress test, however, women were less likely to say they would accept the physician recommended test whether it was a stress test or catheterization.
Given their choice, women and men both preferred a noninvasive evaluation. However, women appeared less likely to follow the physician recommendation for any test or intervention. This might help explain why women received less cardiovascular testing.
Source: http://www.aemj.org/cgi/content/full/14/5_Supplement_1/S106-a

A new study has shown that patients who receive blood transfusions while hospitalized for coronary artery bypass graft (CABG) surgery are more likely to develop an infection after surgery and are at a greater risk of death than those who do not receive a blood transfusion.
These findings could help shed light on why women fare worse after surgery than men as women receive more blood transfusions than men, primarily because of their lower hemoglobin levels

It’s interesting that Bayer Healthcare would donate over $25 million of antibiotics to impoverished countries immediately after its major fiasco of not disclosing data from a Trasyslol study about how the results linked strokes and heart attacks to Trasylol. (Webwire)

It is not yet known exactlyhHow bypass surgery causes kidney damage, but several possible causes have been suggested. Kidney damage may be caused by alteration in the blood flow that occurs while on a heart-lung machine during surgery, or damage may occur when tiny bits of plaque break off of the walls of blood vessels, travel to the kidneys, and block its tiny blood vessels.

Friday—October 13, Bayer AG suspended two senior employees over the company’s failure to provide U.S. regulators with data on its heart-surgery drug Trasylol. Bayer also said it had hired an independent counsel to investigate its actions regarding the disclosure of the preliminary results from the Trasylol study.

While the FDA is conducting its study based on new Trasylol data, they recommend physicians who use Trasylol should carefully monitor patients for the occurrence of kidney, heart, or brain toxicity and promptly report observed adverse event information to the FDA MedWatch program. Physicians should consider limiting Trasylol use to those situations where the clinical benefit of reduced blood loss is essential to medical management and outweighs the potential risks.

On September 29, 2006 German-based Bayer acknowledged that it mistakenly did not inform the U.S. Food and Drug Administration about a retrospective study commissioned by the company to analyze the side effects of aprotinin, aminocaproic acid, and tranexamic acid in patients undergoing coronary artery bypass graft (CABG) surgery. This data was not shared immediately with the FDA because it was preliminary in nature and raised significant questions on the study population, outcomes, and methodology. Bayer has submitted a copy of the preliminary Trasylol report to the FDA and has notified other regulatory authorities. (Yahoo)

On September 21, 2006, FDA held a public meeting of the Cardiovascular and Renal Drugs Advisory Committee to discuss the safety and overall risk-benefit profile for Trasylol.