A boxed warning highlighting serious safety concerns, including reported deaths, with the use of Exjade drug to remove excess iron from the blood, has been added to the medicine's label.
The FDA said the prescribing information for Exjade would now carry a highlighted warning, often called a black box, noting that the drug may cause renal impairment, including kidney failure; hepatic impairment, including liver failure; and gastrointestinal hemorrhage.
Deferasirox (marketed as Exjade) is a rationally-designed oral iron chelator. Its main use is to reduce chronic iron overload in patients who are receiving long-term blood transfusions for conditions such as beta-thalassemia and other chronic anemias.It is the first oral medication approved in the USA for this purpose. (Wiki)