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Archived - Health Canada Takes Additional Safety Measures to Ensure the Safe Use of Clozapine

Starting date:
June 23, 2004
Posting date:
June 23, 2004
Type of communication:
Advisory
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Product Safety
Audience:
General Public
Identification number:
RA-11000118

Health Canada is taking additional steps to ensure the safe use of clozapine, a drug used in the treatment of schizophrenia.

Clozapine is used for patients that are unresponsive to, or not tolerant to, conventional drugs. The use of clozapine is known to potentially cause a decrease in white blood cells, known as agranulocytosis, which impairs the body's defense mechanism against infection. As such, patients must have regular blood tests to monitor their white blood cell count. Results are recorded in patient registries, which are accessed by treating physicians and pharmacists to ensure that the drug is not given to a patient at risk for agranulocytosis.

In consultation with the Canadian Psychiatric Association (CPA), the Schizophrenia Society of Canada and the National Association of Pharmacy Regulatory Authorities (NAPRA), Health Canada is taking a number of steps to improve safety measures for clozapine use in Canada. These steps involve a) revisions to the Product Monographs of all clozapine products marketed in Canada b) a new proposed statement to be added to the Patient Registration Form and c) a quot;Questions and Answers" patient information leaflet.

Currently, patients on clozapine, treating physicians and dispensing pharmacists must all be enrolled in registries to track the use of clozapine, and monitor the health of the patients on the drug. From 1991 to 2003, there was only one company distributing clozapine in Canada. Since 2003, other companies have received approval to market these products, which has led to the establishment of new, independent, registries. As a result, some health care professionals and companies have experienced difficulties in the transfer of patients' information among registries.

In order to address these difficulties, Health Canada is proposing the inclusion of additional information to be added to the Patient Registration Form. This new Patient Registration Form statement will help to improve the way patient information is collected and shared by facilitating the exchange of information between registries.

Health Canada is also providing a "Questions and Answers" patient information leaflet, to help patients better understand the information exchange process between registries. Both of these measures will achieve a more efficient network of independent registries, and therefore improve the continuity of care of patients treated with clozapine.

This advisory applies to the following currently marketed clozapine products:

  • Apo-clozapine (Apotex Incorporated)
  • Clozaril (Novartis Pharmaceuticals Canada Ltd.)
  • Gen-Clozapine (GenPharm)

The new statement for the Patient Registration Form and the patient information leaflet on consent are available at the following address:

Health Canada has also posted a Dear Healthcare Professional Letter and a Notice to Hospitals discussing the above-mentioned information. These letters can be accessed at Health Canada's website.

Any suspected adverse reactions associated with clozapine can be reported directly to the product manufacturer or to:

Canadian Adverse Drug Reaction Monitoring Program (CADRMP)
Marketed Health Products Directorate
Health Canada
Address Locator: 0701C
Ottawa, Ontario, K1A 0K9
Tel: (613) 957-0337 or Fax: (613) 957-0335

To report an Adverse Reaction, consumers and health professionals may call toll free:
Tel: 866 234-2345
Fax: 866 678-6789

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.


Media enquiries

Margot Geduld/Carole Saindon
Health Canada
(613) 957-1588

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(613) 957-2991