Exjade Side Effects May Be Increased for Some Users: FDA

The FDA issued an Early Communication on Friday to alert healthcare professions that they are reviewing potential Exjade side effects, which may increase the risk of kidney failure, internal bleeding and death for some older patients.

Exjade (deferasirox) is an iron chelating medication manufactured by Novartis for people with chronic anemia and iron overload due to a blood transfusion. Side effects of Exjade have already been linked to kidney failure, as well as gastrointestinal ulcers and hemorrhages, all of which can be fatal.

The FDA indicates that a review of adverse event data for Exjade and data from a global safety database suggest that older patient suffering from myelodysplastic syndrome (MDS) may face a greater risk when compared to younger patients with other chronic anemias.

No final conclusion has been made about the cause and effect relationship between Exjade and this emerging safety issue, and the FDA has not advised doctors to stop prescribing the drug. Once a final conclusion is reached, the FDA intends to provide additional information and determine whether any regulatory action is warranted.

“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 Early Communication on Exjade. “These factors include the patients’ advanced age, the seriousness of their disease, other medical disorders they may have and their need for blood transfusions.

Myelodysplastic syndrome, better known as MDS, is a disorder where the patient’s bone marrow does not create enough normal blood cells, resulting in anemia. Those with MDS often need regular blood transfusions, which can cause a buildup of iron in the blood known as iron overload. Iron overload can cause damage to the heart, liver and other organs.

Exjade was approved by FDA in November 2005, and generated $531 million in sales for Novartis last year.

In 2007, the FDA warned that the drug could cause kidney failure and had resulted in at least eight deaths. The drug’s warning label was subsequently updated to include risks of kidney failure, blood vessel inflammation, hives, and hypersensitivity.

The FDA indicates that they are working with Novartis to determine whether further revisions to the warning label are necessary to alert doctors and consumers about the risk of Exjade side effects among certain patients, so that they can make an informed decision about whether the benefits outweigh the risks.