Reactions 1122 - 7 Oct 2006 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 2006. Available from: URL: http://www.fda.gov 809067868 1 Reactions 7 Oct 2006 No. 1122 0114-9954/10/1122-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved

FDA advises caution for Trasylol

Download PDF Report

Upload
leminh
View
212
Download
0

Embed Size (px)

Citation preview

Page 1: FDA advises caution for Trasylol

Reactions 1122 - 7 Oct 2006

FDA advises caution for TrasylolThe US FDA has advised healthcare providers to

warrant caution in the use of Trasylol [aprotinin] in thelight of a new safety study conducted by BayerPharmaceuticals, which shows that Trasylol use mayincrease the risk for serious kidney damage, congestiveheart failure (CHF), strokes and death.

The new observational study, which involved67 000 patients undergoing coronary bypass whoreceived Trasylol (n=30 000) or other products,indicated that Trasylol recipients were at increased riskof CHF, stroke, kidney failure and death. The FDA hassaid that it is evaluating the results of this safety study. Inthe meantime, the agency has recommended thathealthcare providers should carefully monitor Trasylolrecipients for the occurrence of toxicity, particularly tothe brain, heart or kidneys, and to consider restrictingTrasylol use to situations where the clinical benefits ofreduced blood loss outweigh the potential risks.

Previously, the FDA and Bayer Pharmaceuticals havemade similar recommendations regarding Trasylol usebased on results of two observational studies.*However, patients were not randomised to treatmentarms in the recent Bayer study and the two previousstudies, which complicates the assessment of whetherTrasylol treatment or other factors increased the chancefor 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 Sep2006. Available from: URL: http://www.fda.gov 809067868