Reactions 1382 - 17 Dec 2011

■ The US FDA is to review postmarketing reports ofserious bleeding associated with dabigatran etexilate[Pradaxa].* Although serious and even fatal eventshave been reported, the agency is analysing the datato evaluate whether the reports of bleeding amongPradaxa recipients are occurring more commonly thanwould be expected, based on the clinical trial data thatsupported the drug’s approval. Postmarketing reportsare being analysed, in collaboration with BoehringerIngelheim, to identify evidence of inappropriatedosing, use of interacting drugs, or any other clinicalfactors that might result in a bleeding event. However,at this time, the FDA considers the benefits of Pradaxato exceed any potential risks, provided it is usedappropriately, in accordance with the approved druglabel.

* see also Reactions 1378 p3; 801085519

FDA. FDA Drug Safety Communication: Safety review of post-market reportsof serious bleeding events with the anticoagulant Pradaxa (dabigatran etexilatemesylate). FDA Drug Safety Newsletter : 7 Dec 2011. Available from: URL:http://www.fda.gov 803064499

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Reactions 17 Dec 2011 No. 13820114-9954/10/1382-0001/$14.95 © 2010 Adis Data Information BV. All rights reserved