Novartis sends out Dear Doctor letter for Exjade

The US Food and Drug Administration and Swiss drug major Novartis have notified health care professionals of changes to the Warnings and Adverse Reactions sections of the product labeling for Exjade (desferasirox), its drug for chronic iron overload due to blood transfusions in patients two years of age and older. Cases of acute renal failure, some with a fatal outcome, have been reported following the post-marketing use of Exjade. Most of the fatalities occurred in those with multiple co-morbidities in advanced stages of hematological disorders. Additionally, there were reports of cytopenias, including agranulocytosis, neutropenia and thrombocytopenia with Exjade where some of the patients died. The FDA noted that the relationship of these episodes to treatment is uncertain, although most of these patients had pre-existing hematologic disorders frequently associated with bone marrow failure.