The U.S. Food and Drug Administration (FDA) is reviewing adverse event information for Exjade from a database that tracks all patients prescribed Exjade, as well as a company-sponsored global safety database. According to information obtained by the FDA, 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 the age of 60 and the adverse events are not uncommon in people with MDS, said the FDA. 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, the FDA found several factors that make it difficult for the Agency to draw conclusions without further analysis, including advanced age, disease severity, other medical disorders, and the need for blood transfusions.
Exjade is an iron chelating agent approved for use in the treatment of patients two years of age and older who have been diagnosed with chronic anemia and iron overload as a result of receiving blood transfusions as part of their therapy.
MDS is a collection of disorders in which the bone marrow does not function normally and the body does not produce sufficient normal blood cells, which can result in anemia. Patients with MDS and other chronic anemias may need many blood transfusions to treat the anemia. Receiving multiple blood transfusions can cause “iron overload” in patients—too much iron in the body—which can damage the heart, liver, and other organs.
Adverse drug events have been associated with Exjade, some fatal, including kidney and liver failure, particularly in patients diagnosed with other conditions that would make them more susceptible to kidney or liver problems, gastrointestinal ulcers, and/or hemorrhage. The FDA has not determined if 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.
Patients taking Exjade who have questions about their treatment should speak with their healthcare professional.
Meanwhile, the FDA is working with Novartis, the company that manufactures Exjade, regarding potential revisions to prescribing information to warn healthcare professionals about the possible risks of using Exjade in certain patients and to ensure Exjade’s benefits outweigh its potential risks, particularly in older patients and patients with MDS. The FDA urges healthcare professionals and patients to report side effects from the use of Exjade to the FDA’s MedWatch Adverse Event Reporting program.
The FDA also notes that this information reflects its current analysis of available data concerning Exjade; however, this does not mean the Agency has concluded there is a causal relationship between Exjade and the emerging safety issue or that it is advising health care professionals to discontinue prescribing Exjade. FDA is considering, but has not reached a conclusion about whether this information warrants any regulatory action.