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Reactions 1132 - 16 Dec 2006 The US FDA has informed healthcare professionals that Baxter has revised the Warnings section of the labelling for heparin sodium injection to highlight the potential of delayed onset of heparin-induced thrombocytopenia (HIT), and to highlight that HIT may develop into heparin-induced thrombocytopenia and thrombosis (HITT). Furthermore, the agency states that thrombotic events could be the initial presentation of HITT, which can happen up to several weeks after heparin discontinuation, and that patients should be evaluated for HIT and HITT if they present with thrombocytopenia or thrombosis after heparin discontinuation. FDA. Heparin sodium injection. Internet Document : [1 page], 8 Dec 2006. Available from: URL: http://www.fda.gov 801013809 1 Reactions 16 Dec 2006 No. 1132 0114-9954/10/1132-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved

The US FDA has informed healthcare professionals that Baxter has revised the Warnings section of the labelling for heparin sodium injection

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Page 1: The US FDA has informed healthcare professionals that Baxter has revised the Warnings section of the labelling for heparin sodium injection

Reactions 1132 - 16 Dec 2006

■ The US FDA has informed healthcare professionalsthat Baxter has revised the Warnings section of thelabelling for heparin sodium injection to highlight thepotential of delayed onset of heparin-inducedthrombocytopenia (HIT), and to highlight that HIT maydevelop into heparin-induced thrombocytopenia andthrombosis (HITT). Furthermore, the agency statesthat thrombotic events could be the initial presentationof HITT, which can happen up to several weeks afterheparin discontinuation, and that patients should beevaluated for HIT and HITT if they present withthrombocytopenia or thrombosis after heparindiscontinuation.FDA. Heparin sodium injection. Internet Document : [1 page], 8 Dec 2006.Available from: URL: http://www.fda.gov 801013809

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Reactions 16 Dec 2006 No. 11320114-9954/10/1132-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved