The FDA ( Food and Drug Administration ) is reviewing adverse event information for Exjade ( Deferasirox ) from a database that tracks all patients who are prescribed Exjade and a company-sponsored global safety database. This information suggests there may be a greater risk for adverse events such as kidney failure, gastrointestinal hemorrhage ( potentially fatal bleeding ) and deaths in patients with myelodysplastic syndrome ( MDS ) compared to patients without these conditions. Many of these patients are over age 60 and the adverse events are problems that are not uncommon in people with MDS. The number of deaths and serious adverse events seem to be fewer in younger patients with other chronic anemias such as beta-thalassemia and sickle cell disease.

In reviewing the reports of adverse events and deaths, FDA has found several factors that make it difficult for the Agency to draw conclusions without further analysis. These factors include the patients' advanced age, the seriousness of their disease, other medical disorders they may have and their need for blood transfusions.

Exjade has known adverse drug events, some of which have been fatal. These events include kidney and liver failure, particularly in patients who have other conditions that would make them more susceptible to kidney or liver problems, and gastrointestinal ulcers and/or hemorrhage.

FDA has not determined whether or not patients with MDS or older patients treated with Exjade are at greater risk for adverse events or death compared to patients of a similar age or diagnosis who were not treated with Exjade, or compared to patients who are younger who have other chronic anemias and have been treated with Exjade.

Exjade is an iron chelating agent that is approved for use in the treatment of patients two years of age and older who have chronic anemia and iron overload as a result of receiving blood transfusions as part of their therapy.

Source: FDA, 2009

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