Exjade (deferasirox) - Early Communication
Audience: Hematology-Oncology healthcare professionals
[Posted 09/25/2009] FDA notified healthcare professionals of an Early Communication regarding an ongoing review of safety issues with Exjade (deferasirox). New safety data suggests there may be a greater number of adverse events and deaths in patients using Exjade who are over sixty years old who have myelodysplastic syndrome (MDS). Exjade, an iron chelator, is an oral medication approved in 2005 for patients aged two and older with chronic anemia (low red blood cell counts) and iron overload as a result of receiving blood transfusions.
FDA is working with Novartis to add new information in the Contraindications, Warnings, and Precautions sections of the prescribing information, to alert healthcare professionals of the risks and adverse events, including acute renal failure and gastrointestinal hemorrhages that in rare cases, especially in older patients with blood-related malignancies and/or low platelet counts, have been fatal.
Any adverse events or quality problems that may be related to the use of this product should be reported to the FDA's MedWatch Adverse Event Reporting program online, by phone [1-800-332-1088], or by returning the postage-paid FDA Form 3500 by mail or fax [1-800-FDA-0178].
[09/25/2009 - Early Communication About An Ongoing Safety Review of Exjade (deferasirox) - FDA]