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Early Communication about an Ongoing Safety Review of Deferasirox (marketed as Exjade)

FDA has concluded that there is a greater risk for kidney and liver impairment and failure, potentially fatal gastrointestinal bleeding and deaths in some patients with myelodysplastic syndromes (MDS) who have been treated with Exjade. On January 28th 2010, FDA approved a Boxed Warning and added new language to the Contraindications, Warnings and Precaution, and Drug Interactions sections of the Exjade drug label. Please go to the MedWatch Alert and read the Dear Healthcare Professional Letter from the manufacturer.

This information reflects FDA’s current analysis of available data concerning these drugs. Posting this information does not mean that FDA has concluded there is a causal relationship between the drug products and the emerging safety issue.  Nor does it mean that FDA is advising health care professionals to discontinue prescribing these products. FDA is considering, but has not reached a conclusion about whether this information warrants any regulatory action. FDA intends to update this document when additional information or analyses become available.

9/25/2009

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.

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. 

Patients who are taking Exjade and have questions about their treatment should talk with their healthcare professional. 

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.

MDS is a collection of disorders in which the bone marrow does not function normally and the body does not make enough normal blood cells (this 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).  Iron overload, can damage the heart, liver. and other organs in the body.

FDA is working with Novartis, the company that manufactures Exjade, regarding potential revisions to the prescribing information to warn healthcare professionals about the possible risks of using Exjade in certain patients and to ensure that the benefits of Exjade outweigh the potential risks, particularly in older patients and patients with MDS. 

This early communication is in keeping with FDA’s commitment to inform the public about ongoing safety reviews of drugs. The Agency will communicate its final conclusions when the analysis of these and other data are complete.

The FDA urges both healthcare professionals and patients to report side effects from the use of Exjade to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, or by fax, using the contact information at the bottom of this page.

 

 

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