Label Changes for:
Arixtra (fondaparinux sodium) Injection
October 2008
Changes have been made to the WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- October 2008
| The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Read about the new physician labeling format. |
| Sections Modified |
Summary of Changes to Contraindications and Warnings |
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WARNINGS
PRECAUTIONS
ADVERSE REACTIONS
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WARNINGS Hemorrhage: ...Isolated cases of elevated aPTT temporally associated with bleeding events have been reported following administration of Arixtra (with or without concomitant administration of other anticoagulants) (see ADVERSE REACTIONS: Postmarketing Experience). Laboratory Testing: ...In post-marketing experience, isolated occurrences of aPTT elevations have been reported following administration of -Arixtra (see PRECAUTIONS: Laboratory Tests and ADVERSE REACTIONS: Postmarketing Experience). Thrombocytopenia: ...Isolated occurrences of thrombocytopenia with thrombosis that manifested similar to heparin induced thrombocytopenia have been reported with use of Arixtra in postmarketing experience (see ADVERSE REACTIONS: Postmarketing Experience)... |
Label approved 10/17/2008 is not available on this site
