FDA advises caution for Trasylol
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FDA advises caution for Trasylol The US FDA has advised healthcare providers to warrant caution in the use of Trasylol [aprotinin] in the light of a new safety study conducted by Bayer Pharmaceuticals, which shows that Trasylol use may increase the risk for serious kidney damage, congestive heart failure (CHF), strokes and death. The new observational study, which involved 67 000 patients undergoing coronary bypass who received Trasylol (n=30 000) or other products, indicated that Trasylol recipients were at increased risk of CHF, stroke, kidney failure and death. The FDA has said that it is evaluating the results of this safety study. In the meantime, the agency has recommended that healthcare providers should carefully monitor Trasylol recipients for the occurrence of toxicity, particularly to the brain, heart or kidneys, and to consider restricting Trasylol use to situations where the clinical benefits of reduced blood loss outweigh the potential risks. Previously, the FDA and Bayer Pharmaceuticals have made similar recommendations regarding Trasylol use based on results of two observational studies.* However, patients were not randomised to treatment arms in the recent Bayer study and the two previous studies, which complicates the assessment of whether Trasylol treatment or other factors increased the chance for serious heart or kidney complications, says the FDA. * See Reactions 1091 p2; 801013401 and Reactions 1089 p3; 809059828 FDA. FDA Statement Regarding New Trasylol Data. Media Release : 29 Sep 809067868 2006. Available from: URL: http://www.fda.gov
0114-9954/10/1122-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved
Reactions 7 Oct 2006 No. 1122
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