Important Safety Information Regarding the Use of Effexor® (venlafaxine HCI) Tablets and Effexor® XR (venlafaxine HCI) Capsules in Children and Adolescents - Wyeth Pharmaceuticals

Date: 2003-09-24

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The Marketed Health Products Directorate (MHPD), Therapeutic Products Directorate (TPD) and Biologics and Genetic Therapies Directorate (BGTD) post safety alerts, public health advisories, press releases and other notices from industry as a service to health professionals, consumers, and other interested parties. Although MHPD, TPD and BGTD approve therapeutic products, MHPD, TPD and BGTD do not endorse either the product or the company. Any questions regarding product information should be discussed with your health professional.

This is duplicated text of a letter from Wyeth Pharmaceuticals.
Contact the company for a copy of any references, attachments or enclosures.

September 10, 2003

Dear Health Care Professional,

Following discussions with Health Canada, Wyeth wishes to inform you about important emerging safety information on the use of Effexor^® (venlafaxine HCI) Tablets and Effexor^® XR (venlafaxine HCI) Capsules in children and adolescents. A Dear Health Care Professional Letter was issued in the United States on August 22, 2003. The same information is being distributed in Canada. See attached copy¹.

We are now working with Health Canada to update the Canadian labeling.

In Canada, Effexor^® Tablets and Effexor^® XR Capsules have not been and are not recommended for use in patients under 18 years.

If you have any questions about this information, please contact Wyeth Medical Information at
1-800-461-8844.

Sincerely,

original signed by

Neil Maresky, M.B., B. Ch.
Vice President
Scientific Affairs

References:
¹. Wyeth Pharmaceuticals, in the United States (US), voluntarily sent out a Dear Health Care Professional Letter on August 22, 2003 to inform Health Care Professionals about changes to the Effexor^® Tablets and Effexor^® XR Extended Release Capsules Prescribing Information. Attached is a copy of the US Letter for your information.

Wyeth Canada has voluntarily sent a copy of the US letter to Health Canada to inform them of the safety information conveyed to Health Care Professionals in the US and indicated that a labeling change in Canada would be forthcoming.

Any suspected adverse incident 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 AR Reporting Form and the AR Guidelines can be found on the TPD web site or in The Canadian Compendium of Pharmaceuticals and Specialties.