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FDA issues early communication about safety review of deferasirox
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The FDA issued an early communication Friday warning physicians that deferasirox might increase adverse events and risk for death in elderly patients with myelodysplastic syndrome.
However, the agency cautioned that the patients’ advanced age, the seriousness of their disease, their other medical disorders and need for blood transfusions make it difficult to draw final conclusions until more analysis is completed.
Deferasirox (Exjade, Novartis) is an oral iron chelator approved in 2005 for patients with chronic anemia and iron overload from receiving blood transfusions. The recommended initial daily dose is 20 mg/kg body weight dispersed into a liquid.
The FDA says new safety data suggest the drug might be associated with increased incidence of adverse events including acute renal failure and gastrointestinal hemorrhages in patients aged 60 or older who have myelodysplastic syndrome. In rare cases, the adverse events have been fatal in elderly patients with blood-related malignancies and/or low platelet counts.
The agency has not determined whether patients with myelodysplastic syndrome or older patients treated with deferasirox are at greater risk compared with patients of a similar age or diagnosis who were not assigned to the drug. Likewise, the agency is unsure whether the risk is greater compared with younger patients with other chronic anemias and who have been treated with deferasirox. Death and serious adverse events appear to be less common in younger patients with beta thalassemia anemia or sickle cell disease.
Deferasirox is associated with kidney and liver failure, especially in patients with other conditions that would make them more susceptible to kidney or liver problems, and gastrointestinal ulcers and/or hemorrhage.
