February 18, 2010
Exjade gains boxed warningThe FDA and Novartis have notified healthcare professionals about changes to the Exjade (deferasirox tablets) Prescribing Information, including a Boxed Warning. The Boxed Warning states that Exjade may cause renal and hepatic impairment, including failure, as well as gastrointestinal hemorrhage. In some reported cases, these reactions were fatal. These reactions were more frequently observed in patients with advanced age, high risk myelodysplastic syndromes, underlying renal or hepatic impairment or low platelet counts. New language has also been added to the Contraindications, Warnings and Precautions, and Drug Interactions sections.
Exjade is indicated for the treatment of chronic iron overload due to blood transfusions in patients ≥2 years of age.
For more information please visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm200850.htm.