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November 7, 2007
Final Report: Risks of Renal Failure and Death following Use of Aprotinin or Aminocaproic Acid during CABG Surgery Part B. Cilck to read, ‘11-07-2007 | Final Report: Risks of Renal Failure and Death following Use of Aprotinin or Aminocaproic Acid during CABG Surgery Part B.’
November 5, 2007
November 2007 Leverkusen, Germany and West Haven, Connecticut, USA. – Following consultation with the German Federal Institute for Drugs and Medical Devices (BfArM), the U.S. Food and Drug Administration (FDA), Health Canada, and other health authorities, Bayer announced today that it has elected to temporarily suspend worldwide marketing of Trasylol® (aprotinin injection) until final results from the Canadian BART trial can be compiled, received and evaluated. The company took this global action following direction from the German BfArM and requests from the FDA and other regulators that Bayer temporarily suspend Trasylol marketing in their respective countries until final BART data were available. The BART study is an independent randomized, controlled trial being conducted in high-risk cardiac surgery patients. Continue reading, ‘11-05-2007 | Bayer Temporarily Suspends Global Trasylol® (aprotinin injection) Marketing.’
October 25, 2007
October 2007 Leverkusen, Germany and West Haven, Connecticut, USA. – Today Bayer announced new guidance to physicians and health care providers regarding the use of Trasylol® (aprotinin injection) in patients at an increased risk of blood loss and blood transfusion undergoing coronary artery bypass graft (CABG) surgery with cardiopulmonary bypass (CPB). Continue reading, ‘10-25-2007 | Bayer Issues Additional Guidance to Physicians on Trasylol® (aprotinin injection).’
September 12, 2007
Committees also recommend further changes to US Label for Trasylol and additional safety studies
Leverkusen, Germany; West Haven, CT, USA, September 12, 2007 — Today, the Cardiovascular and Renal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee to the U.S. Food and Drug Administration (FDA) held a meeting to discuss the risk /benefit profile of Trasylol® (aprotinin injection), a Bayer drug used in coronary artery bypass graft (CABG) surgery. At the close of the meeting, based on the Trasylol data in Bayer’s controlled clinical studies and after considering data from observational studies and public testimony presented at the meeting, the Committees recommended that US marketing authorization for Trasylol should be continued. Continue reading, ‘09-12-2007 | FDA Advisory Committees Recommend Continued US Marketing Authorization for Trasylol.’
September 12, 2007
Report on Computerized Inpatient Data from the Premier Perspective Comparative Database. Continue reading, ‘09-12-2007 | Final Report: Risks of Renal Failure and Death following Use of Aprotinin or Aminocaproic Acid during CABG Surgery Part A.’
September 12, 2007
Report on Computerized Inpatient Data from the Premier Perspective Comparative Database. Continue reading, ‘09-12-2007 | ADDENDUM To the Final Report: Risks of Renal Failure and Death following Use of Aprotinin or Aminocaproic Acid during CABG Surgery Part A.’
August 16, 2007
August 2007 Leverkusen, Germany and West Haven, Connecticut, USA. – Today, Bayer HealthCare reported findings of Mr. William Taylor’s independent investigation on the i3 Drug Safety observational study on Trasylol® (aprotinin injection) to the U.S. Food and Drug Administration (FDA) and other relevant regulatory authorities and also conveyed actions the company has taken to ensure that this sort of mistake is never again repeated. Mr. Taylor’s full report and information regarding enhanced company practices and procedures have been posted on company websites. Continue reading, ‘08-16-2007 | Bayer Reports Findings of Trasylol Independent Investigation.’
February 26, 2007
February 2007 West Haven, CT, USA. – Bayer has conducted a preliminary review of the observational study entitled “Mortality Associated with Aprotinin During 5 Years Following Coronary Artery Bypass Graft Surgery” by Mangano et al. as well as the editorial by T. Bruce Ferguson, Jr., MD from the East Carolina University, Greenville, NC, scheduled for publication on February 7, 2007 in the Journal of the American Medical Association (JAMA) regarding long-term mortality rates in coronary artery bypass graft surgery patients including those treated with aprotinin. Continue reading, ‘02-26-2007 | Bayer Responds to study and commentary published in Journal of American Medical Association (JAMA).’
January 25, 2007
Leverkusen, Germany and West Haven, Connecticut, January 25, 2007 – Bayer HealthCare has decided to end three ongoing clinical studies investigating the safety and efficacy of Trasylol® (aprotinin injection) on transfusion requirements and blood loss in adults undergoing: elective spinal fusion surgery, pneumonectomy or esophagectomy for cancer, and radical or total cystectomy in bladder cancer. Continue reading, ‘01-25-2007 | Bayer Pharmaceuticals Trasylol® (aprotinin injection) Press Release.’
December 15, 2006
West Haven, Connecticut – Bayer HealthCare Pharmaceuticals All rights reserved. , in collaboration with the FDA, is informing health care professionals of important safety revisions to the U.S. product information for Trasylol® (aprotinin injection) following an FDA Advisory Committee meeting earlier this year. These safety revisions relate primarily to renal function and hypersensitivity. Continue reading, ‘12-15-2006 | Bayer Pharmaceuticals Trasylol® (aprotinin injection) Press Release.’