Healthy Skepticism Library item: 12034

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Tuffs A.
Bayer withdraws heart surgery drug
BMJ 2007 Nov 17; 335:(7628):1015
http://www.bmj.com/cgi/content/short/335/7628/1015?etoc

Abstract:

The German drug company Bayer has suspended worldwide marketing of Trasylol (aprotinin), its antifibrinolytic drug, after the requests of the drug regulating authorities in Germany and Canada and the advice of the Food and Drug Administration in the United States. Infusions of aprotinin have been used to stop excessive bleeding during heart surgery.

A recent Canadian trial known as the BART trial (blood conservation using antifibrinolytics: a randomised trial in high risk cardiac surgery patients), coordinated by the Ottawa Health Research Institute, was stopped because preliminary results showed an increased risk of death from the drug. The trial was started in 2001 and includes 3000 patients undergoing heart surgery.

Initial results had shown that Trasylol had lessened bleeding but the drug was linked to increased risk of death from all causes compared with patients taking two other antifibrinolytics-aminocaproic acid or tranexamic acid.

Bayer has announced that the suspension is temporary, . . .