Surgery News - January 2008 - (Page 7) J A N U A RY 2 0 0 8 • SURGERY NEWS THORACIC 7 Bayer Temporarily Halts Marketing of Aprotinin B Y A L I C I A A U LT Else vier Global Medical Ne ws ayer Pharmaceuticals Corp. has agreed to stop marketing aprotinin—at the Food and Drug Administration’s request—in light of preliminary data that suggest that the antifibrinolytic may be increasing death rates in patients who receive the drug during coronary artery bypass surgery. Concurrently with the FDA request, the German Federal Institute for Drugs and Medical Devices—which has the authority to do so—ordered the company to stop selling aprotinin in that country. Soon after, Bayer announced it was suspending marketing of aprotinin worldwide. In the United States, the company has halted all new shipments and is working with the FDA to phase supplies out of the marketplace, said a company spokeswoman. Bayer is not recalling the product, however. The FDA decided to take action after preliminary data from the BART study B and professor in the cardiovascular and thoracic surgery division at the University of Kentucky, Lexington. He said he’s waiting to see the full data from the BART study, adding that so far, all he has heard “is a combination of rumors and fact.” Added Dr. Ferraris: “We can’t predicate guidelines on rumors.” From what’s been made public so far, the BART study seems to be a paradox, suggesting an edge for aprotinin in reducing bleeding and need for transfusion, and yet increasing hemorrhagic death, said Dr. Ferraris. “Looking at this from the outside, there’s something that doesn’t compute here,” he said, adding that he would continue to use aprotinin in some highrisk cases. But, he said, he would have “careful preoperative discussions with patients and with families,” and that he will likely revise the informed consent document. And he hopes that there will be more information from the BART study by the time his facility’s current supplies of aprotinin are exhausted. Since a study published in the New Eng- land Journal of Medicine questioned aprotinin’s safety (N. Engl. J. Med. 2006;354: 353-65), surgeons have increasingly hesitated to use the drug—not for scientific reasons, but for medicolegal reasons, said Dr. Ferraris. Bayer has said that aprotinin has not been a top seller, accounting for $135 million in revenues in the first three quarters of 2007. Dr. Ferraris disclosed that he has lectured for Bayer and the Medicines Co., and that he also has received research funds from Bayer. ■ Surgical Wounds Pressure Ulcers Orthopedic Trauma Wounds Diabetic Wounds Skin Grafts Open Abdominal Wounds Partial-Thickness Burns FOR OUTCOMES YOU CAN TRUST, THERE’S ONLY ONE PRELIMINARY DATA SUGGEST INCREASING DEATHS AMONG PATIENTS WHO RECEIVE THE DRUG DURING CORONARY ARTERY BYPASS SURGERY. (Blood conservation using antifibrinolytics: A randomized trial in a cardiac surgery population) suggested that aprotinin increased 30-day mortality, compared with epsilon-aminocaproic acid or tranexamic acid, said Dr. John Jenkins, director of the office of new drugs at the FDA’s Center for Drug Evaluation and Research. That trial was halted by the Ottawa Health Institute in late October. “At this time FDA cannot identify a specific patient population where the benefit outweighs the risk,” said Dr. Jenkins, in a briefing with reporters. Aprotinin has been the subject of two FDA advisory panel meetings. Following the committee’s advice in September 2006, the agency narrowed the drug’s indicated use because of hypersensitivity reactions and the potential for renal damage. In September 2007, after examining several observational studies suggesting that aprotinin increased the risk of death, the panel concluded that the drug should stay on the market because of its proven ability to decrease blood loss and the need for transfusion. The evidence of benefit was strong enough to convince the Society of Thoracic Surgeons Blood Conservation Guideline Task Force to recommend aprotinin’s use in cardiac surgery guidelines published in May (Ann. Thorac. Surg. 2007;83:S2786). Those guidelines aren’t likely to be changed any time soon, said task force chairman Dr. Victor Ferraris in an interview. “There’s been a lot of political and regulatory noise about aprotinin that has caused some concern without really much evidence,” said Dr. Ferraris, an ACS Fellow ■ ■ Helps promote wound healing Non-adherent layer of the V.A.C.® Abdominal Dressing System assists in protecting the abdominal contents May allow for delayed primary closure Minimizes suturing through fascia Assists in wound stabilization via dressing splinting effect Collects and quantifies fluid Open Abdominal Wound ■ ■ ■ ■ To learn more about V.A.C.® Therapy, visit us online at www.woundvac.com or call toll-free 1-800-275-4524. Note: Specific indications, contraindications, warnings, precautions, and safety tips exist for this product and therapy. Please consult Product Instructions for Use prior to applications. ©2007 KCI Licensing, Inc. All rights reserved. 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