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Information update

Archived - Important Safety Information on IRESSA® (gefitinib) 250 mg Tablets - AstraZeneca Canada Inc.

Starting date:
August 26, 2005
Posting date:
August 26, 2005
Type of communication:
Information Update
Source of recall:
Health Canada
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 IRESSA (gefitinib) 250 mg Tablets

AstraZeneca Canada Inc.

1004 Middlegate Road

Mississauga Ontario

Canada L4Y 1M4

Tel.: (905) 277-7111

Fax: (905) 275-6271

August 26, 2005

Subject: Health Canada Endorsed Important Information on IRESSA® (gefitinib) 250 mg tablets

Health Canada, in consultation with AstraZeneca Canada Inc., is recommending new restrictions on the use of the lung cancer drug IRESSA, the brand name for gefitinib. While IRESSA has not been shown to have a significant impact in extending patient survival, a recent study has found it to be effective in shrinking tumours in patients with a certain tumour characteristic.

IRESSA is generally used when a specific form of lung cancer fails to respond to two other types of treatments. The drug targets a protein called Epidermal Growth Factor Receptor (EGFR). Patients can be grouped into three categories based on the level of EGFR expressed in their tumour: positive, negative and unknown. The recent study suggests that patients whose tumours are EGFR expression status positive or unknown have significantly better rates of tumour shrinkage when treated with IRESSA versus a sugar pill. However, EGFR negative patients appear unlikely to benefit from IRESSA treatment.

The data from this pivotal post-marketing study will be reviewed by Health Canada in an expedited manner and the labeling will be updated.

Any suspected adverse reaction can be reported to:

AstraZeneca Canada Inc.

1004 Middlegate Road

Mississauga, ON 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:

Bureau of Metabolism, Oncology and Reproductive Sciences (BMORS)

Tel: (613) 941-3171

Fax: (613) 941-1365

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.

Should you have any questions or require additional information regarding IRESSA® , please contact your health care provider (physician, nurse or pharmacist) or AstraZeneca Medical Information at 1-800-668-6000(English) and/or 1-800-461-3787(French).

IRESSA® and the AstraZeneca logo are trademarks of the AstraZeneca group of companies.

[Text of letter ends]