Reports of Hepatic Failure with ^PrEXJADE^* (deferasirox) - For the Public

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Contact: Bureau of Metabolism, Oncology and Reproductive Sciences (BMORS)

The Health Products and Food Branch (HPFB) posts on the Health Canada web site safety alerts, public health advisories, press releases and other notices as a service to health professionals, consumers, and other interested parties. These advisories may be prepared with Directorates in the HPFB which includes pre-market and post-market areas as well as market authorization holders and other stakeholders. Although the HPFB grants market authorizations or licenses for therapeutic products, we do not endorse either the product or the company. Any questions regarding product information should be discussed with your health professional.
 
This is duplicated text of a letter from Novartis Pharmaceuticals Canada Inc.
Contact the company for a copy of any references, attachments or enclosures.

Public Communication
Health Canada Endorsed Important Safety Information on ^PrEXJADE^* (deferasirox)

March 7, 2008

Subject: Reports of severe liver problems with ^PrEXJADE^* (deferasirox)

Following discussions with Health Canada, Novartis wishes to provide you with updated safety information regarding reports of severe liver problems with EXJADE^*.

EXJADE^* is used to treat chronic iron overload caused by blood transfusions for the treatment of anemias for adults, adolescents, and children aged 6 years and over; and in children aged 2 to 5 years who cannot be adequately treated with deferoxamine.

Therapy with EXJADE^* should be initiated and maintained by physicians experienced in the treatment of chronic iron overload due to blood transfusions.

Recently, a post-marketing report of severe liver problems with encephalopathy (altered brain function) was communicated to the FDA by a patient in the U.S. who had received EXJADE^* for five days. The patient's hospital records showed that the patient had a history of alcohol use and had slightly abnormal liver function before using EXJADE^*. In addition, the patient was treated for a non-approved use while having a serum ferritin level (marker of iron level in the blood) that was more than 10 times lower than the level recommended to start EXJADE^* therapy. EXJADE^* use was stopped and the patient recovered. Based on the information available, the potential role of EXJADE^* cannot be excluded, however, after review of this case, Novartis and external medical experts agree that there are extenuating circumstances around this case.

As of October 31, 2007, there have been a total of 36,797 patients treated with EXJADE*: 31,444 since its approval and 5,353 patients in clinical studies. There are a total of 24 international reports of liver failure - 21 post-marketing and 3 reports from clinical studies. Two of the 24 reports were reported by patients in Canada. Most reports of liver failure involved patients that already had multiple medical conditions, including liver disease (cirrhosis) and multi-organ 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.

A copy of the Health Care Professional letter and this communication are available on the Health Canada website.

If you have any questions about the above information or about EXJADE^* please talk to your doctor, 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. For more information on EXJADE^* please consult the Consumer Information document available at
 www.novartis.ca.

Managing marketed health product-related adverse reactions depends on health care professionals and consumers reporting them, in addition to reports collected from clinical trials. Reporting rates determined on the basis of spontaneously reported post-marketing adverse reactions are generally presumed to underestimate the risks associated with health products. If you have had a serious or unexpected reaction to EXJADE^* you may notify either Novartis Pharmaceuticals Canada Inc. or Health Canada as follows:

For media inquiries, please contact Silvie Letendre at (514) 633-7872.

Sincerely,

original signed by

Jean-Marie Leclerc, M.D. FRCP(C)
Chief Scientific Officer and Senior Vice-President Clinical and Regulatory Affairs

^PrEXJADE^* is a registered trademark.