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Archived - Public Advisory: Liver Problems Associated With Use of ACCOLATE (zafirlukast) in Some Patients - AstraZeneca - For the Public
- Starting date:
- December 12, 2002
- Posting date:
- December 18, 2002
- Type of communication:
- Public Communication
- Subcategory:
- Drugs
- Source of recall:
- Health Canada
- Audience:
- General Public
- Identification number:
- RA-1900010
This is duplicated text of a letter from AstraZeneca
Contact the company for a copy of any references, attachments or enclosures.
Notice about Health Canada advisories
December 12, 2002
Public Advisory
Liver Problems Associated With Use of Accolate® in Some Patients
Important Safety Information Concerning Liver Problems for Patients Taking Accolate® (zafirlukast)
AstraZeneca Canada Inc. 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. 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
If you are taking Accolate® and you experience any of these symptoms it is important that you contact your physician immediately. This advisory is in addition to a letter issued to health professionals reminding them of the above-mentioned safety information. As well, the product monograph for Accolate® is being revised to inform physicians that if liver problems are suspected, patients should discontinue Accolate® immediately instead of waiting for results of liver function tests.
If you have questions regarding your current prescription, please contact your physician or pharmacist, or contact AstraZeneca Canada Inc. at 1-800-668-6000.
Any suspected adverse drug reactions can also be reported to:
Canadian Adverse Drug Reaction Monitoring Program (CADRMP)
Marketed Health Products Directorate
HEALTH CANADA
Address Locator: 0201C2
OTTAWA, Ontario, K1A 1B9
Tel: (613) 957-0337 or Fax: (613) 957-0335
Toll free for consumers and health professionals:
Tel: 866 234-2345, Fax: 866 678-6789
cadrmp@hc-sc.gc.ca
The ADR Reporting Form and the ADR Guidelines can be found on the TPD web site or in The Canadian Compendium of Pharmaceuticals and Specialties.