Safety Alerts & Recalls

What does this mean?

At this time, the increased risk of side effects from Exjade (desferasirox) in older patients with MDS has not been established. However, if you over 60 and have MDS and take Deferasirox, it is a good idea to follow up with your doctor at your next appointment to review this new safety information. For most patients, the benefits of Deferasirox will continue to outweigh the risks.

If you are experiencing or develop symptoms associated with kidney or liver injury, including weakness or fatigue, fever, yellowing of the skin or whites of the eyes, brown urine, abdominal pain, nausea, vomiting, light-colored stools, itching, or loss of appetite, you should contact your doctor as soon as possible.

If you are taking Deferasirox and have questions or concerns about your treatment, please speak with your doctor or other health care professional. Do not make any adjustments to your medication without first talking to your doctor.

FDA Early Communication About Ongoing Safety Review of Exjade

The FDA is reviewing safety issues with Exjade (desferasirox). Exjade has known adverse drug events, including kidney and liver failure, gastrointestinal ulcers and/or hemorrhage (bleeding). New safety data suggests there may be a greater number of these adverse events and deaths in patients using Exjade who are over sixty years old who have myelodysplastic syndrome (MDS). 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, or low red blood cell counts). 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). Exjade is an oral medication used to treat iron overload caused by receiving blood transfusions.

Because the patients' advanced age, the seriousness of their disease, other medical disorders they may have and their need for blood transfusions may contribute to these reported adverse events, it is difficult for the FDA to draw conclusions without further analysis. The FDA's analysis of the available information is ongoing and the FDA will follow up with additional information once the review is complete.

For more information please visit: more information here

Source: FDA
Publication Date: 2009-09-28
Last Updated: 2009-12-05

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