ROCKVILLE, Md -- September 25, 2009 -- The US Food and Drug Administration (FDA) is reviewing adverse event information for Exjade from a database that tracks all patients who are prescribed deferasirox (Exjade). This information suggests there may be a greater risk for adverse events such as kidney failure, gastrointestinal haemorrhage, and deaths in patients with myelodysplastic syndrome (MDS) compared with patients without these conditions.
Many of these patients are aged over 60 years and the adverse events are problems that are not uncommon in people with MDS. The number of deaths and serious adverse events seem to be fewer in younger patients with other chronic anaemias such as beta Thalassemia and Sickle Cell disease.
In reviewing the reports of adverse events and deaths, the FDA has found several factors that make it difficult for the Agency to draw conclusions without further analysis. These factors include the patients' advanced age, the seriousness of their disease, other medical disorders they may have, and their need for blood transfusions.
Deferasirox has known adverse drug events, some of which have been fatal. These events include kidney and liver failure -- particularly in patients who have other conditions that would make them more susceptible to kidney or liver problems -- and gastrointestinal ulcers and/or haemorrhage.
The FDA has not determined whether or not patients with MDS or older patients treated with deferasirox are at greater risk for adverse events or death compared with patients of a similar age or diagnosis who were not treated with deferasirox, or compared with patients who are younger who have other chronic anaemias and have been treated with deferasirox.
The FDA is working with Novartis, the company that manufactures deferasirox, regarding potential revisions to the prescribing information to warn healthcare professionals about the possible risks of using deferasirox in certain patients and to ensure that the benefits of deferasirox outweigh the potential risks, particularly in older patients and patients with MDS.
The Agency will communicate its final conclusions when the analysis of these and other data are complete.
The FDA urges both healthcare professionals and patients to report side effects from the use of Exjade to the FDA's MedWatch Adverse Event Reporting program.
SOURCE: US Food and Drug Administration
E-Mail this DGNews to a colleague
