Alerts
Deferasirox (Exjade): Early Communication about an Ongoing Safety Review
September 28, 2009
An ongoing safety review of deferasirox (Exjade) suggests that deferasirox may be associated with an increased risk of kidney failure, gastrointestinal hemorrhage, and death in patients over age 60 with myelodysplastic syndrome (MDS). Deferasirox is an oral iron chelator used to treat iron overload in patients receiving repeated blood transfusions for chronic anemia.
Known adverse events with deferasirox include kidney failure, liver failure, gastrointestinal ulcers and bleeding, and death. These adverse events are less common in younger patients and in patients without blood-related malignancies or low platelet counts. The association of increased adverse events in older patients with MDS requires further analysis to rule out patient specific factors.
The Contraindications, Warnings, and Precautions sections of the prescribing information are undergoing updates to reflect new safety information. Urge deferasirox patients with questions about this treatment to talk to their healthcare provider. Continue to report adverse events related to the use of deferasirox to the MedWatch Adverse Event Reporting program.
Additional information on this topic is available at the following links:
- FDA MedWatch Early Communication:
http://www.fda.gov/Safety/MedWatch/SafetyInformtion/SafetyAlertsforHumanMedicalProducts/ucm183840.htm - Early Communication:
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ DrugSafetyInformationforHeathcareProfessionals/ucm183651.htm
Updated
September 28, 2009; University of Utah, Drug Information Service. Copyright 2009, Drug Information Service, University of Utah, Salt Lake City, UT.
