Exjade label to warn of hepatic failure.

Novartis informed health care professionals Dec. 12 of changes made to the prescribing information for Exjade Tablets for Oral Suspension. The Warnings and Adverse Reactions sections of the labeling have been revised to include information about post-marketing reports of hepatic failure, some with a fatal outcome, in patients treated with Exjade. Most of these events occurred in patients greater than 55 years of age. Most reports of hepatic failure involved patients with significant co-morbidities, including liver cirrhosis and multi-organ failure.

Exjade is used to treat chronic iron overload due to blood transfusions (transfusional hemosiderosis) 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 patients with multiple comorbidities 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.

Novartis and FDA have advised health care professionals yo monitor serum creatinine in patients who are at increased risk of complications, having pre-existing 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.

Read the letter at Dear Healthcare Professional Letter.