Label Changes for:
Arixtra (fondaparinux sodium) injection
Changes have been made to the CONTRAINDICATIONS and ADVERSE REACTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
- History of serious hypersensitivity reaction (e.g., angioedema, anaphylactoid/anaphylactic reactions) to ARIXTRA
6 ADVERSE REACTIONS
6.5 Postmarketing Experience
- the occurrence of serious allergic reactions (including angioedema and anaphylactoid/anaphylactic reactions)
USE IN SPECIFIC POPULATIONS
- Safety and effectiveness of Arixtra in pediatric patients have not been established. Because risk for bleeding during treatment with Arixtra is increased in adults who weigh <50 kg, bleeding may be a particular safety concern for use of Arixtra in the pediatric population.