CAPRELSA (vandetanib) - Serious Risk of Abnormal Heart Rhythm - For the Public

Starting date:

February 15, 2012

Posting date:

February 15, 2012

Type of communication:

Public Communication

Subcategory:

Drugs

Source of recall:

Health Canada

Audience:

General Public

Identification number:

RA-190001056

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

Public Communication - Health Canada Endorsed Important Safety Information on CAPRELSA (vandetanib)

February 15, 2012

Subject: Serious risk of abnormal heart rhythm for CAPRELSA^® (vandetanib)

AstraZeneca Canada Inc. ("AstraZeneca Canada"), in consultation with Health Canada, has informed Canadian healthcare providers of important information regarding the safety of CAPRELSA^® (vandetanib). Health Canada has recently approved CAPRELSA to treat medullary thyroid cancer in adult patients where either the tumour cannot be removed by surgery or it has spread from the thyroid gland to other parts of the body. 

• CAPRELSA can cause serious heart rhythm changes which may result in sudden death, if left untreated.
• CAPRELSA is only available through a Restricted Distribution Program.
• CAPRELSA can only be prescribed by a doctor who has completed the certification to participate in the CAPRELSA Restricted Distribution Program and who is experienced in the use of anti-cancer drugs.
• Patients must be enrolled in the program by their certified doctor, in order to receive CAPRELSA.

In addition to abnormal heart rhythm, rash and other skin reactions, diarrhea, increased blood pressure and vision abnormalities have also been reported in patients taking CAPRELSA. For a complete list of adverse events associated with CAPRELSA, please refer to the CAPRELSA Product Monograph.

AstraZeneca Canada has sent a letter to Canadian health care professionals informing them of this safety information. You may view this letter on for Health Professionals - 2012 website.

Adverse Events

Managing health product-related adverse reactions for drugs marketed in Canada depends on health care professionals and patients reporting them to the company or Health Canada. Therefore, the number of adverse reactions reported is generally believed to be less than those that actually occur. Any case of adverse reactions in patients receiving CAPRELSA should be reported to AstraZeneca Canada or Health Canada.

AstraZeneca Canada Inc.

1004 Middlegate Road

Mississauga, Ontario

Canada L4Y 1M4

Telephone: 1-877-404-8277

An Adverse Event form may be accessed at the Restricted Distribution Program Web site; please fax the completed form to 1-800-267-5743.

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

• Report online at MedEffect^TM Canada
• Call toll-free at 1-866-234-2345
• Complete a Reporting Form and:
  • Fax toll-free to 1-866-678-6789, or
  • Mail to: Canada Vigilance Program
    
    Health Canada
    
    Postal Locator 0701E
    
    Ottawa, Ontario K1A 0K9

The Reporting Forms, postage paid labels, and Guidelines can be found on the MedEffect^TM Canada Web site in the Adverse Reaction Reporting section.

For other health product inquiries related to this communication, please contact Health Canada at:

Bureau of Metabolism, Oncology and Reproductive Sciences

E-mail: BMORS_Enquiries@hc-sc.gc.ca

Telephone: 613-941-3171

Fax: 613-941-1365

Should you have any questions about CAPRELSA or the Restricted Distribution Program, please do not hesitate to contact AstraZeneca Medical Information at 1-800-668-6000 (English) and/or 1-800-461-3787 (French).

original signed by

Dr. Neil Maresky, M.B., B.Ch.

Vice President, Scientific Affairs

AstraZeneca Canada Inc.

CAPRELSA^® and the AstraZeneca logo are registered trademarks of the AstraZeneca group of companies.