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

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