On AirDon't miss
Mr. Monsour’s Interview on the radio show, America’s Best Lawyers.
Listen Now
Monsour Law Firm
404 N Green St
Longview, Texas 75601
PO Box 4209
Longview, TX 75606
903-758-5757
1-800-815-2911
Fax 903-230-5010
E-Mail Us
Trasylol has been linked to causing heart surgery side effects and bypass surgery medication side effects. A study concluded that the use of Trasylol may increase the chance for death, serious kidney damage, congestive heart failure, and strokes.
Trasylol, or aprotinin, a product derived from bovine lung tissue, inhibits certain enzymes that increase the risk for bleeding. Trasylol administration aids the body's ability to prevent bleeding.
Patients undergoing coronary artery bypass grafting (CABG) using cardiopulmonary bypass may be at risk for bleeding complications due to prior use of anti-coagulants or clinical conditions that predispose to bleeding. Trasylol is used to decrease this bleeding risk. Learn more here.
Since January, 2006, FDA has been conducting a safety review of Trasylol (aprotinin injection). The review was triggered by the results of two published research studies: one that reported an increase in the chance of kidney failure, heart attack and stroke in patients treated with Trasylol compared to those treated with other similar drugs, and the other that reported an increase in kidney dysfunction compared to another drug. 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. At that meeting, the committee discussed the findings from the two published observational studies, the Bayer worldwide safety review, and the FDA review of its own post-marketing database.
On September 27, 2006, Bayer Pharmaceuticals told the FDA that it had conducted an additional safety study of Trasylol. The preliminary findings from this new observational study of patients from a hospital database reported that use of Trasylol may increase the chance for death, serious kidney damage, congestive heart failure, and strokes. The FDA was not aware of these new data when it held the September 21, 2006 Advisory Committee meeting on Trasylol safety and is actively evaluating this new data and their implications for appropriate use of the drug.
In the published studies and the recently supplied Bayer study, patients were not assigned at random to receive various treatments, but rather had their treatment chosen by their physician as part of their standard medical care. Consequently, in these safety studies, patients receiving Trasylol may have had a higher chance for serious complications to begin with as compared to patients receiving no treatment or treatment with another drug intended to decrease bleeding. This possibility complicates the assessment of whether the available studies show that Trasylol treatment, rather than other factors, increased the chance for serious kidney or heart complications.
The new study was done for Bayer by a contract research organization. Existing hospital data from 67,000 records of patients undergoing coronary artery bypass graft surgery were examined. 30,000 of the patients were treated with Trayslol and 37,000 were treated with alternate products. Using complex epidemiological and statistical methods, the report suggested that patients receiving Trasylol were at increased risk for death, kidney failure, congestive heart failure, and stroke.
Healthcare providers and patients are encouraged to report adverse event information to FDA via the MedWatch program by phone (1-800-FDA-1088), by fax (1-800-FDA-0178), or by the Internet at http://www.fda.gov/medwatch/index.html.
Bayer A.G., the German pharmaceutical giant, failed to reveal to federal drug officials the results of a large study suggesting that a widely used heart-surgery medicine might increase the risks of death and stroke, the Food and Drug Administration announced Friday. Bayer scientists even appeared at a public meeting called by the FDA on Sept. 21 to discuss the possibility that the drug, Trasylol, might have serious risks. But they did not mention the study or its worrisome results. In a highly unusual move, the food and drug agency released a public health advisory saying it had learned of the study's existence only on Wednesday. Preliminary results of the study demonstrate "that use of Trasylol may increase the chance for death, serious kidney damage, congestive heart failure and strokes," the advisory said. Other effects include kidney failure, heart attack (myocardial infarction), and congestive heart failure.