Archived - Exjade (deferasirox) - Proposed Changes to the Canadian Product Monograph - For the Public

Starting date:

December 3, 2009

Posting date:

December 3, 2009

Type of communication:

Public Communication

Subcategory:

Drugs

Source of recall:

Health Canada

Audience:

General Public

Identification number:

RA-19000746

This is duplicated text of a letter from Novartis Pharmaceuticals Canada Inc.
Contact the company for a copy of any references, attachments or enclosures.

Notice about Health Canada advisories

Public Communication - Health Canada Endorsed Important Safety Information on EXJADE (deferasirox)

December 3, 2009

Subject: Use of EXJADE* (deferasirox) in Patients Diagnosed with Myelodysplastic Syndrome (MDS) and in Elderly Patients Regarding Kidney Problems and Bleeding in the Stomach or Intestine

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.

Novartis has proposed changes to the Canadian Product Monograph for EXJADE* (including the Consumer Information Section), and these changes are currently under review by Health Canada.

• There may be a greater risk of kidney problems, bleeding in the stomach or intestine (potentially fatal) and deaths in patients with myelodysplastic syndrome (MDS) and in elderly patients compared to younger patients with other anemias such as ß-thalassemia and sickle cell disease. Many of these adverse events are common to elderly patients and patients with MDS, making it difficult to draw any conclusions about the potential relationship between EXJADE* and the reporting of these adverse events.
• Patients should not use EXJADE* if they have been diagnosed with myelodysplastic syndrome (MDS) in a high risk category or have an advanced cancer.
• Kidney function should be monitored before the start of treatment with Exjade and during treatment. Patients should also ensure that they are well hydrated (drink lots of fluid). Patients should tell their doctor if they produce less urine than usual.
• There have been rare reports of bleeding in the stomach or intestine (fatal in rare cases), especially in patients with advanced blood cancer and/or low blood platelet counts.

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 (Medical Information).

For more information on EXJADE* please consult the Consumer Information document available on the Novartis Web site.

Managing marketed health product-related adverse reactions depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post marketing adverse reactions are generally presumed to underestimate the risks associated with health product treatments. Any case of serious or unexpected adverse reactions in patients receiving EXJADE* should be reported to Novartis or Health Canada at the following addresses:

Novartis Pharmaceuticals Canada Inc.
385 Bouchard Blvd.
Dorval (QC) H9S 1A9
Telephone: 1-877-631-6775 x 3425 (Drug Safety & Epidemiology)

Any suspected adverse reaction can also be reported to:
Canada Vigilance Program
Marketed Health Products Directorate
HEALTH CANADA
Address Locator: 0701D
Ottawa, Ontario, K1A 0K9
Telephone: 613-957-0337 or Fax: 613-957-0335
To report an Adverse Reaction, consumers and health professionals may call toll free:
Telephone: 1-866-234-2345
Fax: 1-866-678-6789
CanadaVigilance@hc-sc.gc.ca

The Adverse Reaction Reporting Form and the Adverse Reaction Guidelines can be found on the Health Canada web site or in The Canadian Compendium of Pharmaceuticals and Specialties.

For other inquiries related to this communication, please contact Health Canada at:
Bureau of Metabolism, Oncology and Reproductive Sciences
Therapeutic Products Directorate
E-mail: BMORS_Enquiries@hc-sc.gc.ca
Telephone: 613-941-3171
Fax: 613-941-1365

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

*EXJADE is a registered trademark.