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FDA REPORTS HIGHER NUMBER OF DEATHS REPORTED WITH EXJADE®
September 24, 2009. The U. S. Food and Drug Administration (FDA) notified healthcare professionals of an Early Communication regarding an ongoing review of safety issues with EXJADE® (deferasirox). New safety data suggests there may be a greater number of adverse events and deaths in patients using EXJADE® who are over sixty years old who have myelodysplastic syndrome (MDS).
EXJADE® is prescribed to patients 2 years of age or older for the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis). Iron overload may occur in a wide range of anemic patients who receive blood transfusions for disorders of the blood, including those with thalassemia, sickle cell disease, myelodysplastic syndromes and Diamond-Blackfan anemia. Iron is a critical element that allows cells in the body to get the oxygen needed for essential body functions. Many cells in the body use iron, including blood cells, muscle cells, liver cells, bone marrow and spleen. Although it is important to have enough iron in your body, having too much iron results in chronic iron overload. EXJADE® works by attaching to excess iron and removing the iron from inside certain cells in the body, such as liver cells. The EXJADE®-iron combination leaves the cells and exits the body when you have a bowel movement.
The myelodysplastic syndromes (MDS) are a group of diseases in which the production of blood cells by the bone marrow is disrupted. In contrast to leukemia, in which one specific type of blood cell (the white cell) is produced in excessively large numbers, the production of any, and sometimes of all, types of blood cells is affected in patients with MDS. Within your bone marrow, stem cells - your master cells, from which all other specialized cells are formed - normally develop into mature blood cells. But in people with MDS, the stem cells don't mature or function properly, leading to a lack of healthy cells. Treatment in the form of blood transfusions can lead to iron overload.
EXJADE® was approved by the FDA for sale in the U.S. in 2005. The drug is manufactured in the U.S. by Novartis. Patients taking EXJADE® have developed serious and sometimes fatal side effects, including kidney failure, liver failure and stomach bleeding. In May, 2007, Novartis updated the EXJADE® warnings and adverse reactions information on the product label to state that "[c]ases of acute renal failure, some with a fatal outcome, have been reported following the post marketing use of EXJADE®. Most of the fatalities occurred in patients with multiple co-morbidities and who were in advanced stages of their hematological disorders." However, in 2008, Novartis stated that EXJADE® has "a defined, clinically manageable safety profile across all age groups." These statements could be misleading to doctors prescribing the medication as well as consumers ingesting the drug.
If you or someone you love were injured after using EXJADE® you have valuable legal rights. Please fill out our online form, or call 1-850-444-9500 or toll free at 1-888-839-3775 to discuss your rights with one of the experienced dangerous medicine attorneys at our firm.
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Telephone: 1-850-444-9500 | Toll Free: 1-888-839-3775
