September 25, 2009
FDA safety alert on ExjadeThe FDA has notified healthcare professional of an Early Communication regarding an ongoing review of safety issues with Exjade (deferasirox tablets for oral suspension, from Novartis). New safety data suggests there may be a greater number of adverse events and deaths in patients using Exjade who are >60 years old who have myelodysplastic syndrome (MDS). The FDA is working with Novartis to add new information to the Contraindications, Warnings, and Precautions sections of the Exjade 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.
Exjade is an iron chelating agent indicated for the treatment of chronic iron overload due to blood transfusions in patients ≥2 years of age.
For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm183840.htm.