Articles tagged with: Exjade
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The U.S. Food and Drug Administration’s (FDA) evaluation of Exjade (deferasirox) has concluded that the drug should not be prescribed to myelodysplastic syndromes (MDS) patients with poor prognoses or high-risk disease due to the possibility of liver or kidney impairment and gastrointestinal bleeding. It now requires Novartis, which markets Exjade, to include a highlighted “black box warning” in the prescribing information cautioning physicians and patients about its potentially serious or fatal side effects.
Exjade is an iron chelating agent that works to remove excess iron, which may have built up…
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FDA Declines To Approve Clolar As Treatment For Adult AML Patients – On October 6, Genzyme Corporation reported that the FDA has declined to approve the company’s application to market Clolar (clofarabine) as a treatment for adult acute myeloid leukemia (AML) patients. Clolar is currently approved for the treatment of children with acute lymphoblastic leukemia who have relapsed or failed to respond to at least two other drugs. Genzyme says that the FDA is recommending a randomized, controlled clinical study of Clolar in adult AML patients as a condition for approving Clolar’s use in those patients, and that the company plans to meet with the FDA to discuss next steps. Genzyme is also investigating Clolar as a treatment for MDS and several other conditions. For more information, please see the Genzyme press release. For information on Clolar trials for MDS patients, please see the U.S. government’s Clinical Trials Web site.
MDS U.S. Patient And Family Forum – The Myelodysplastic Syndromes Foundation will be holding a Patient and Family Forum in Pittsburgh, PA on October 21. Guest speaker Dr. James Rossetti of the Western Pennsylvania Cancer Institute will provide important information for MDS patients and their families. The event is free, but registration is required. For more information about registering for the event or for a detailed listing of upcoming U.S. or international forums, please see the MDS Foundation Web site.
For a more detailed listing of MDS-related events, please check the MDS Beacon Events Calendar.
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The U.S. Food and Drug Administration announced on September 25 that it is examining the safety of Exjade (deferasirox) when prescribed to myelodysplastic syndromes (MDS) patients. An initial FDA data analysis shows that MDS patients taking Exjade have a greater risk of serious side effects than patients without MDS. The FDA announced it needs to further analyze the specifics of the Exjade side effects, however, before coming to a final conclusion about the drug’s safety for MDS patients.
Exjade is an iron chelating agent, a type of drug used to bind free…
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The U.S. Food and Drug Administration announced on its Web site today that it is investigating the safety of the drug Exjade (deferasirox) when prescribed to patients with myelodysplastic syndromes (MDS). The investigation was initiated after an FDA data analysis found that MDS patients taking Exjade appear to have a higher risk of serious, often fatal, side effects.
Exjade is prescribed to MDS patients receiving blood transfusions to reduce the excess levels of iron that often occur as a result of transfusions.
The Beacon will cover this news in more detail in a later news…
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What is excess iron?
Iron is an essential element to all living organisms, as it is an important aspect of health and disease. Iron is essential to red blood cells since they house most of the body’s iron content. Iron is normally bound by different proteins which prevent it from reacting destructively with other cells in the body. However, excess iron can overload these proteins, leading to free iron circulating and accumulating in the body due to the lack of an active mechanism to excrete iron. Iron deposits, especially in…