News Headlines
New Important Information for U.S. Hospital Pharmacists and Wholesalers/Distributors
Bayer Responds to BART Study Article and Editorial Published in NEJM
Final Report: Risks of Renal Failure and Death following Use of Aprotinin or Aminocaproic Acid during CABG
Surgery Part B
Bayer Temporarily Suspends Global Trasylol® Marketing
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. Click to
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Bayer Issues Additional Guidance to Physicians on Trasylol®
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). Click to
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FDA Advisory Committees Recommend Continued US Marketing Authorization for Trasylol
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 Bayers 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.Click to
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Final Report: Risks of Renal Failure and Death following Use of Aprotinin or Aminocaproic Acid during CABG Surgery Part A
Report on Computerized Inpatient Data from the Premier Perspective Comparative Database
ADDENDUM To the Final Report: Risks of Renal Failure and Death following Use of Aprotinin or Aminocaproic Acid during CABG Surgery Part A
Report on Computerized Inpatient Data from the Premier Perspective Comparative Database
Bayer Reports Findings of Trasylol Independent Investigation
Company outlines corrective actions it has undertaken
August 2007 Leverkusen, Germany and West Haven, Connecticut, USA. - Today, Bayer HealthCare reported findings of Mr. William Taylors 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. Taylors full report and information regarding enhanced company practices and procedures have been posted on company websites. Click to
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Investigator Report
Key Committees: Bayer Drug Safety
Bayer Responds to study and commentary published in
Journal of American Medical Association (JAMA)
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. Click to
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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.Click to
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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.
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Bayer Appoints Independent Investigator
to Review Trasylol® Study Issues
Leverkusen Bayer announced today that it has appointed independent counsel to review the companys actions in regards to disclosure of preliminary results from an observational study on Trasylol® to the U.S. Food and Drug Administration. Bayer has retained Fred F. Fielding Esq., from the law firm Wiley Rein & Fielding LLP and charged him with conducting a complete and thorough investigation into the matter and with providing recommendations to Bayer regarding subsequent actions that the company should take.
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Current Trasylol® (aprotinin injection) News
Bayer has acknowledged that it mistakenly did not inform the U.S. Food and Drug Administration prior to a recent FDA Advisory Committee meeting about a retrospective observational study commissioned by the company to analyze the 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 agency because it was preliminary in nature and raised significant questions on the study population, outcomes and methodology.
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Bayer Acknowledges That New Trasylol Study Was Not Disclosed Prior to Recent FDA Cardio-Renal Advisory Committee Meeting.
Leverkusen Bayer acknowledged today that it mistakenly did not inform the U.S. Food and Drug Administration about a retrospective study commissioned by the company to
analyze the 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 agency
because it was preliminary in nature and raised significant questions on the study population, outcomes and methodology.
Bayer believes that despite the highly preliminary nature of this data,
the information should have been shared with the FDA prior to the September 21st Advisory Committee meeting held to assess the safety and efficacy of Trasylol. This was a mistake on the companys part.
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Links to
Related FDA Communications
November 5, 2007 FDA Statement
September 29, 2006 FDA Statement
February 8, 2006 FDA Public Health Advisory
FDA Revises Labeling for Trasylol (Aprotinin Injection) to Strengthen Safety Warnings and Limit Usage of Drug to Specific Situations
Click for IMPORTANT Trasylol Safety Information
About Trasylol
Trasylol® is indicated for prophylactic use to reduce perioperative blood loss and the need for blood transfusion in patients undergoing cardiopulmonary bypass in the course of coronary artery bypass graft surgery who are at an increased risk for blood loss and blood transfusion.
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