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Bayer Removes Remaining Stocks of Aprotinin; Access Limited to Investigational Use ROCKVILLE, Md -- May 15, 2008 -- Bayer HealthCare Pharmaceuticals Inc. has notified the US Food and Drug Administration (FDA) that the company will begin removing the remaining aprotinin (Trasylol) stock from the US market, most of which is in warehouses and hospitals or physician's stock. The US FDA will work with Bayer to ensure a smooth and complete process. On November 5, 2007, the FDA announced that Bayer Pharmaceuticals Corp. agreed to an FDA-requested marketing suspension of aprotinin, a drug used to control bleeding during heart surgery. At that time, preliminary results from the Blood Conservation Using Antifibrinolytics in a Randomized (BART) Trial suggested an increased risk for death compared with 2 other drugs used to control bleeding. Under a limited-use agreement, access to aprotinin is limited to investigational use according to the procedures described in a special treatment protocol. The protocol allows treatment for certain patients who are at increased risk of blood loss and transfusions during coronary artery bypass graft surgery and who have no acceptable alternative therapy. Physicians using aprotinin in this situation must also verify that the benefits of the drug clearly outweigh the risks for their patients. The FDA limits access to certain drugs to patients with serious or immediately life-threatening disease or conditions who lack other therapeutic options and may benefit from such therapies. This type of access requires the submission of a protocol, which is reviewed and approved by the agency. Bayer has agreed to provide aprotinin through this mechanism for the limited use described above. Results from BART, the randomised, controlled Canadian study that prompted last November's marketing suspension of aprotinin, were published this week. The data contained in this article indicate that aprotinin increases the risk for death compared with tranexamic acid or aminocaproic acid. The findings from this randomised study are similar to those from an observational study that was discussed at a September 2007 FDA advisory committee meeting. Based upon the data available at the time, the advisory committee recommended continued marketing of aprotinin. However, the FDA requested the marketing suspension in the interest of patient safety based on the serious nature of the outcomes suggested in the preliminary data. The committee also advised that a large, randomised clinical study was needed to further assess aprotinin safety compared with other drugs. This recently published Canadian study helps address this need for additional information. The FDA has not yet received full study data from the study's researchers at the Ottawa Health Research Institute, Ottawa, Ontario, but supports Bayer's decision to completely remove aprotinin from regular use in the US market. The FDA is also reviewing the available Canadian study data to reassess the currently active special treatment protocol that provides access to aprotinin. SOURCE: US Food and Drug Administration E-mail this page to a friend or colleague! To print, use this version