EXJADE Reports of Liver Failure, Deaths Lead to Label ChangesMar 11, 2008 | Parker Waichman LLP
EXJADE has been linked to liver failure and deaths in some patients, prompting its manufacturer to add new warnings to its label.
EXJADE, which is known generically as deferasirox, is made by Novartis and is used in the treatment of chronic iron overload caused by blood transfusions for the treatment of anemias for adults, adolescents, and children aged six years and over. EXJADE is also used in children aged two to five years who cannot be adequately treated with deferoxamine.
It is recommended that therapy with EXJADE be initiated and maintained by physicians who are experienced in the treatment of chronic iron overload due to blood transfusions. Recently, cases of severe liver problems— including some with fatal outcomes—have been reported internationally following the post-marketing use or commercial use of EXJADE. Most cases involved patients who suffered from multiple medical conditions, including liver disease (cirrhosis) and multi-organ failure. When taking EXJADE, liver function should be monitored monthly. EXJADE treatment should be ceased if there is any unexplained, persistent, and progressive worsening of liver function.d start EXJADE therapy. A serum ferritin level is a marker of iron level in the blood. The EXJADE use was stopped and the patient recovered. Based on the information available, the potential role of EXJADE cannot be excluded as having a link to the adverse reactions, however, after reviewing this case, Novartis and external medical experts agree that there are extenuating circumstances around this case.
Recently, a report of severe liver problems with altered brain function—encephalopathy—have been reported to the Food and Drug Administration (FDA) in the Unites States in a patient who had taken EXJADE for five days. The patient’s hospital records indicated that the patient also had a history of alcohol use and had slightly abnormal liver function prior to using EXJADE. Also, the patient was treated for a non-approved use of the drug while also having a serum ferritin level that was more than 10 times lower than the level recommended to start EXJADE therapy. A serum ferritin level is a marker of iron level in the blood. The EXJADE use was stopped and the patient recovered. Based on the information available, the potential role of EXJADE cannot be excluded as having a link to the adverse reactions, however, after reviewing this case, Novartis and external medical experts agree that there are extenuating circumstances around this case.
Since October 31, 2007, there have been a total of 36,797 patients treated with EXJADE: 31,444 since its approval and 5,353 who were treated in clinical studies, pre-marketing. Of these patients, there have been a total of 24 international reports of liver failure. Of these international liver failure reports, 21 cases occurred post-marketing and three occurred during clinical studies. Patients in Canada reported two of the 24 reports of liver failure. No patient with normal liver function or without additional life-threatening complications of their underlying disease has developed liver failure.
EXJADE has not been studied in patients with liver problems and must be used with caution in patients with severe liver problems. If you have any questions about the relationship between EXJADE and recent reports of liver problems or about EXJADE in general, please talk to your doctor or pharmacist or contact Novartis Pharmaceuticals Canada Inc. at: 1-800-363-8883.
Although a clear relationship between EXJADE and severe liver problems has not been established, the Consumer Information for EXJADE has been updated to include this important safety information related to current findings linked to liver complications. For more information on EXJADE, the Consumer Information document can be located at: www.novartis.ca.