[Posted 05/22/2007] Novartis and 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
(transfusional hemosiderosis) 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. The
relationship of these episodes to treatment with Exjade is
uncertain. Most of these patients had preexisting hematologic
disorders that are frequently associated with bone marrow failure.
Further, cases of leukocytoclastic vasculitis, urticaria, and
hypersensitivity reactions (including anaphylaxis and angioedema)
were reported.
Healthcare professionals should monitor serum creatinine in
patients who are at increased risk of complications, having
preexisting renal conditions, are elderly, have co-morbid
conditions, or are receiving medicinal products that depress renal
function. Blood counts should also be monitored regularly and
treatment should be interrupted in patients who develop unexplained
cytopenia.
