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Arixtra safety update

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA approves labeling revision for Organon/Sanofi-Synthelabo's deep vein thrombosis agent Arixtra (fondaparinux) Dec. 4, removing a caveat that improved efficacy seen versus Aventis' Lovenox (enoxaparin) may have been influenced by timing of the first dose and eliminating a statement that there was a higher bleeding rate with Arixtra. In the initial review, FDA felt that the rate of bleeding and venous thromboembolisms in clinicals might have been affected by deviance from the dosing schedule (Pharmaceutical Approvals Monthly, May 1, 2002, p. 33). Other labeling revisions include the addition of VTE relative risk reduction figures. Revised labeling could allow the companies to boost sales; Arixtra's launch has been slower than expecte

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