FDA Tracking Possible Problem with Iron Chelator
By John Gever, Senior Editor, MedPage Today
Published: September 25, 2009
The FDA said it was looking into possible increased risk of kidney failure, gastrointestinal bleeding, and death with the iron chelator deferasirox (Exjade) in patients with myelodysplastic syndromes (MDS).
An "early communication" from the agency said it had started a safety review of deferasirox, because two adverse-event databases were showing greater than expected rates of these events in MDS patients, many of whom were older than 60.
The FDA stressed that it had reached no conclusions yet.
"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," according to the announcement. "These factors include the patients' advanced age, the seriousness of their disease, other medical disorders they may have, and their need for blood transfusions."
Kidney and liver failure had already been recognized as adverse effects related to deferasirox, the FDA noted.
"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," the agency said.
It added that possible revisions to the product's label are now under discussion with the manufacturer, Novartis.
Such revisions would "warn healthcare professionals about the possible risks of using Exjade in certain patients and . . . ensure that the benefits of Exjade outweigh the potential risks, particularly in older patients and patients with MDS," according to the announcement.
Deferasirox is used in patients with iron overload as a result of blood transfusions for chronic anemia. It was approved in 2005.
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