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J Thorac Cardiovasc Surg 2008;135:729-731
© 2008 The American Association for Thoracic Surgery

Editorial

The demise of aprotinin: Our share of the blame

Division of Cardiovascular Surgery, Mayo Clinic, Rochester, Minn

Received for publication February 3, 2008; accepted for publication February 4, 2008.

^_* Address for reprints: Thoralf M. Sundt, MD, Division of Cardiovascular Surgery, Mayo Clinica and Foundation, 200 First St, SW, Rochester, MN 55905. (Email: johnson.barbara4@mayo.edu).

The first 300 words of the full text of this article appear below.

"On November 5, 2007, after consultation with various health authorities around the world, Bayer announced that it would temporarily suspend worldwide marketing of Trasylol (aprotinin injection) until final results from the BART [Blood Conservation using Antifibrinolytics: A Randomized Trial in High-Risk Cardiac Surgery Patients] trial are compiled, received and evaluated. Shipments of Trasylol from Bayer distribution centers were halted that day."¹ Many received the news with a combination of frustration at the prospect of losing access to a remarkably effective drug; others seemed quietly to celebrate that the company "finally got what it deserves," a feeling generated by the high cost of the medication and marketing tactics. Likely, to some degree, all of us felt a bit disturbed that the government was reaching down into our practices and passing judgment on a drug the risks and benefits of which we were surely in the best position to evaluate. Shouldn't we be able to sort this out on our own? How could the tables have turned so quickly, and who is responsible for the demise of this agent? Is it the company's fault or the government's fault, or do we share in the blame? How did we lose control of this matter?

Aprotinin has been in clinical use for well over a decade, with an enormous literature behind it. Indeed, a PubMed search today (January 30, 2008) with "Aprotinin" yields 7028 references. But the drug has received particular attention in the last several years after 2 large retrospective studies raised concerns about its safety, reporting an increased risk of death among individuals receiving the medication.^2,3 More concerning, however, has been the preliminary analysis from the BART trial, a large, multicenter, prospective, randomized clinical study being conducted under the auspices of the Ottawa Health Institute at 25 Canadian medical centers. This study . . . [Full Text of this Article]