Exjade

Novartis and the FDA notified healthcare professionals of changes to the warnings and adverse reactions sections of the product labeling for Exjade, a drug used to treat chronic iron overload due to blood transfusions in patients 2 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 patients with multiple co-morbidities and who were in advanced stages of their hematological disorders.

Additionally, there were post marketing reports of cytopenias, including agranulocytosis, neutropenia and thrombocytopenia in patients treated with Exjade where some of the patients died. Further, cases of leukocytoclastic vasculitis, urticaria, and hypersensitivity reactions were reported.

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Published on May-24-07