US FDA warns on renal, hepatic and gastro problems with Novartis' Exjade; clears Roche/Biogen's Rituxan for CLL

In a web site posting yesterday, the US Food and Drug Administration notified health care professionals about recent changes in the Prescribing Information (PI) for Swiss drug major Novartis' Exjade (deferasirox), indicated for the treatment of chronic iron overload due to blood transfusions in patients two years of age and older. New language was added to the Contraindications, Warnings and Precautions and Drug Interactions sections of the PI, including a Boxed Warning, that the product may cause:

' renal impairment, including failure;
' hepatic impairment, including failure; and
' gastrointestinal hemorrhage

In some reported cases, these reactions were fatal, said the agency. These reactions were more frequently observed in patients with advanced age, high risk myelodysplastic syndromes, underlying renal or hepatic impairment or low platelet counts. Exjade therapy requires close patient monitoring, including measurement of serum creatinine and/or creatinine clearance as specified in the PI and serum transaminases and bilirubin as specified in the PI, the FDA noted.