FDA Reviewing Reports of Kidney Failure, Death in Exjade Users

The Food and Drug Administration is looking into reports of kidney failure, gastrointestinal hemorrhage, and death in patients taking the drug Exjade for treatment of Myelodysplastic Syndrome (MDS).

Exjade, known chemically as deferasirox, is a once-daily pill taken to remove chronic excess iron from the body in people who are undergoing blood transfusions. It is made by Novartis.

The FDA today issued a notice stating it is reviewing an undisclosed number of reports of adverse events linked to Exjade, which suggests an increased risk of kidney failure and other medical problems in patients with MDS.

MDS is a group of conditions that result in not enough myeloid blood cells being produced and can lead to increased risks of developing acute myelogenous leukemia. The disease used to be called pre-leukemia.

Most of the MDS patients who have developed complications while taking Exjade are over age 60 and at greater risks of adverse problems associated with the disease, the FDA said. Younger patients appear to be at reduced risk of these adverse events.

The FDA does not know why Exjade may be causing users to suffer complications. Many factors, such as the advanced age of the patients, the degree of their MDS, and other underlying medical conditions may be contributing to the problems, the FDA said.

Other Exjade Warnings Issued

The FDA has issued previous warnings about health risks associated with using Exjade.

In 2007, the FDA warned users of the drug about the risks of hepatic failure, a serious liver disorder. Most of those injuries were suffered by patients with liver cirrhosis and multi-organ failure, the FDA said.

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