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NEW WARNING
Novartis has issued a “Dear Healthcare Provider” letter to announce changes to the prescribing information for the chelate deferasirox (Exjade), which is used to treat chronic iron overload resulting from blood transfusions. Post-marketing studies have led to changes in the Warnings section about hepatic dysfunction and failure based on reports of hepatic failure, sometimes fatal, in patients receiving the drug. Most of the patients affected had other medical comorbidities including cirrhosis and multi-organ failure. Providers are encouraged to monitor liver function before and periodically during therapy. The new safety information also states that there’s risk for renal failure, especially in patients with preexisting renal dysfunction; providers are encouraged to monitor renal function before and periodically during treatment. The dosage section will now also state that the decision to remove accumulated iron should be based on a benefits-versus-risk decision. Additionally, the letter contains reminders of all other safety information related to use of the drug.
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