Label Changes for:
Arixtra (fondaparinux sodium) injection
March 2010
Changes have been made to the PRECAUTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – March 2010
USE IN SPECIFIC POPULATIONS
Pediatric Use
- 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.
