Healthcare Industry News: cardiopulmonary
News Release - October 13, 2006
Bayer Appoints Independent Investigator to Review Trasylol(R) Study IssuesLEVERKUSEN, Germany, Oct. 13 (HSMN NewsFeed) -- Bayer announced today that it has appointed independent counsel to review the company's 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.
Commenting on Mr. Fielding's appointment, Dr. Roland Hartwig, General Counsel, Bayer AG said, "Bayer has acknowledged and regrets the error it made in not sharing with the FDA information regarding this study prior to the September 21st Advisory Committee Meeting on Trasylol®. Bayer immediately initiated a full investigation into the matter and based on our investigation so far, we believe this was a serious error in judgment by two individuals. These individuals have been suspended with immediate effect. We are committed to ascertaining how and why this error occurred, and to ensure that such errors are not repeated we have now retained Mr. Fielding, an attorney of the highest reputation for integrity and independence, to carry on this investigation."
"Bayer will cooperate fully with Mr. Fielding's investigation," Dr. Hartwig continued. "We also anticipate that this independent investigation could result in a specific corrective action plan, if necessary, and we are determined to take all appropriate steps to ensure that something like this does not happen again." The company will also publish the findings when they are complete.
Fred Fisher Fielding is senior partner at Wiley Rein & Fielding a Washington, D.C. law firm. He has served the American government in a number of roles throughout his career and from 1981 to 1986 served as Counsel to the President of the United States for President Reagan. Recently he served as a member on the National Commission on Terrorist Attacks Upon the United States.
Trasylol, a broad-spectrum proteinase inhibitor, modulates the systemic inflammatory response associated with cardiopulmonary bypass (CPB) in the course of CABG surgery.
Approved by the FDA in 1993, Trasylol is the only product indicated for prophylactic use to reduce perioperative blood loss and the need for blood transfusion in patients undergoing CPB in the course of CABG surgery. Full prescribing and warning information is also available at http://www.Trasylol.com.
The effects of Trasylol use in CPB involves a reduction of inflammatory response to surgery, reduced bleeding and decreased re-exploration for bleeding, which translates into a decreased need for allogeneic (blood donated from another individual) blood transfusions.
Important Safety Considerations
Anaphylactic or anaphylactoid reactions are possible when Trasylol is administered. Hypersensitivity reactions are rare in patients with no prior exposure to aprotinin. The risk of anaphylaxis is increased in patients who are reexposed to aprotinin-containing products. The benefit of Trasylol to patients undergoing primary CABG surgery should be weighed against the risk of anaphylaxis should a second exposure to aprotinin be required (see WARNINGS and PRECAUTIONS in the Trasylol prescribing information).
In clinical studies, hypersensitivity and anaphylactic reactions were:
-- rare (<0.1%) in patients with no prior exposure to Trasylol
-- 2.7% overall reaction rate upon re-exposure
-- within 6 months, the incidence was 5 percent
-- after 6 months, the incidence was 0.9 percent
Trasylol is generally well tolerated. In clinical trials, graft patency, myocardial infarction, renal or hepatic dysfunction and mortality were comparable to placebo.
Dr. Michael S. Diehl, phone +49 214 30 58532
Meredith Fischer, Tel: +1 203 812-6485
This news release contains forward-looking statements based on current assumptions and forecasts made by Bayer Group management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in our public reports file with the Frankfurt Stock Exchange and with the U.S. Securities and Exchange Commission (including our Form 20-F). The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
Source: Bayer HealthCare
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