The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.
FDA is reviewing adverse event information for Exjade 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 β 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.
For more information, please visit: Exjade
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