This page has been archived on the Web

Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.

Health professional risk communication

Archived – Important Safety Information Concerning Liver Problems for Patients Taking ACCOLATE® (Zafirlukast) – AstraZeneca Canada Inc. – For the Public

Starting date:
April 19, 2004
Posting date:
April 19, 2004
Type of communication:
Public Communication
Source of recall:
Health Canada
Important Safety Information
General Public
Identification number:

This is duplicated text of a letter from AstraZeneca Canada Inc.

Contact the company for a copy of any references, attachments or enclosures.

Notice about Health Canada advisories

[Text of letter begins]

Public Advisory

Health Canada Endorsed Important Safety Information on Accolate® (zafirlukast)

April 19, 2004

Subject: Important safety information concerning liver problems for patients taking Accolate® (zafirlukast)

AstraZeneca Canada Inc. following discussions with Health Canada would like to update you on important safety information regarding Accolate®, a non-steroidal tablet for chronic treatment of asthma in adults and children 12 years of age and older, available only by prescription.

Analysis of safety databases has shown that some patients taking Accolate® have experienced liver problems, some of which were serious (e.g. hepatitis). Very rarely severe liver injury, including liver failure (which may result in a fatal outcome), has been observed.

Following is a list of symptoms which may be signs of liver problems:

  • feeling sick
  • feeling tired or lacking energy
  • feeling like you have the flu
  • loss of appetite
  • feeling itchy
  • pain on right side of stomach, just below ribs
  • yellow colouring of skin and eyes
  • dark urine
  • discoloured and/or pale stools

If you are taking Accolate® and you experience any of these symptoms it is important that you contact your physician immediately. Patients are advised that medications should not be stopped without consulting their physician. Abruptly stopping asthma medications may result in deteriorating health, which may be life-threatening.

This advisory is in addition to a letter issued to health professionals reminding them of the above-mentioned safety information. The letter that was sent to health professionals can be found on Health Canada website and on the AstraZeneca Website.

The prescribing information for Accolate® is being revised to provide physicians and pharmacists with updated safety information. The "Information for the Patient" section of the Product Monograph will also be updated.

If you have questions regarding your current prescription, please contact your physician or pharmacist. Any suspected adverse drug reactions in patients receiving Accolate® (zafirlukast) can be reported to:

AstraZeneca Canada Inc.

1004 Middlegate Road

Mississauga, Ontario, L4Y 1M4

Tel: 1-800-433-0733

Fax: 1-800-267-5743

Any suspected adverse reaction can also be reported 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

For other inquiries: please refer to contact information.

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

For media inquiries contact Stephanie Engel at (905) 804-5817.

Accolate® is a trademark, the property of the AstraZeneca group.

[Text of letter ends]