Archived - Safety Information Regarding Overdosage of Venlafaxine HCl Extended-Release Capsules - For the Public

Starting date:

August 23, 2008

Posting date:

August 23, 2008

Type of communication:

Public Communication

Subcategory:

Drugs

Source of recall:

Health Canada

Audience:

General Public

Identification number:

RA-19000716

This is duplicated text of a letter from Cobalt Pharmaceuticals Inc., Genpharm, Laboratoire Riva Inc., Novopharm Limited, Pharmascience Inc., ratiopharm, Sandoz Canada Inc. and Wyeth Canada.

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 VENLAFAXINE XR

October 23, 2008

Subject: Safety Information Regarding Overdosage of Venlafaxine HCl Extended-Release Capsules

Health Canada, and the manufacturers of venlafaxine extended-release (XR) capsules wish to advise Canadians that the prescribing information for venlafaxine XR is being updated to include safety information about the risks of overdose.

Venlafaxine is in a class of medicines called serotonin and norepinephrine reuptake inhibitors (SNRIs), and is used to treat depression, generalized anxiety disorder (GAD), social anxiety disorder (or social phobia) and panic disorder. Venlafaxine XR is sold in Canada under several brand names, including Effexor XR, Co Venlafaxine XR, Gen-Venlafaxine XR, Riva-Venlafaxine XR, Novo Venlafaxine XR, PMS- Venlafaxine XR, Ratio-Venlafaxine XR, Sandoz Venlafaxine XR.

We are taking this opportunity to remind Canadians that:

• Patients experiencing depression are at increased risk of suicidal or self-harming thoughts or behaviours.
• Some patients taking antidepressants may feel worse instead of better, particularly within the first few weeks of treatment or when doses are adjusted. For example, they may experience unusual feelings of agitation, hostility or anxiety, or have impulsive or disturbing thoughts that could involve self-harm or harm to others.
• If you, or a family member or a friend are depressed or taking antidepressants, you should seek medical attention immediately if there are signs of worsening depression, especially thoughts or talk about self-harm or suicide.

Managing marketed health product-related adverse reactions depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse reactions are generally presumed to underestimate the risks associated with health product treatments. Any case of overdose or other serious or unexpected adverse reactions in patients receiving venlafaxine XR should be reported to the manufacturer or Health Canada at the following addresses:

Cobalt Pharmaceuticals Inc.

6500 Kitimat Road

Mississauga, Ontario L5N 2B8

Telephone: 1-866-254-6111

Fax: 905-542-0478

Genpharm

Drug Safety

85 Advance Road

Etobicoke, Ontario M8Z 2S6

Telephone: 1-800-668-3174 ext. 152

Fax: 416-236-4363

E-mail: pharmacovigilance@genpharm.ca

Laboratoire Riva Inc.

660 Boul. Industriel

Blainville, Quebec J7C 3V4

Telephone: 1-800-363-7988

Fax: 450-434-2500

Novopharm Limited

Pharmacovigilance and Drug Safety

30 Novopharm Court

Toronto, Ontario M1B 2K9

Telephone: 416-291-8888 ext. 5005

Fax: 416-335-4472

E-mail: PhV@Novopharm.com

Pharmascience Inc.

6111 Royalmount Avenue, Suite 100

Montreal, Quebec H4P 2T4

Telephone: 1-800-363-8805

Fax: 514-342-7764

ratiopharm

17800 Lapointe

Mirabel, Quebec J7J 1P3

Telephone: 1-800-337-2584

Fax: 1-800-313-7673

Sandoz Canada Inc.

145, Jules-Leger

Boucherville, Quebec J4B 7K8

Telephone: 1-800-343-8839 ext. 4636

Fax: 1-888-243-6221

Wyeth Canada

Medical Information and Pharmacovigilance

50 Minthorn Boulevard

Markham, Ontario L3T 7Y2

Telephone: 1-800-461-8844

Fax: 905-470-4385

Any suspected adverse reaction can also be reported to:

Canada Vigilance Program

Marketed Health Products Directorate

HEALTH CANADA

Address Locator: 0701C

Ottawa, Ontario, K1A 0K9

Telephone: 613-957-0337 or Fax: 613-957-0335

To report an Adverse Reaction, consumers and health professionals may call toll free:

Telephone: 866-234-2345

Fax: 866-678-6789

CanadaVigilance@hc-sc.gc.ca

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

Marketed Health Products Directorate (MHPD)

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

Tel.: 613-954-6522

Fax: 613-952-7738

Authorized by:

Cobalt Pharmaceuticals Inc.

Genpharm

Laboratoire Riva Inc.

Novopharm Limited

Pharmascience Inc.

ratiopharm

Sandoz Canada Inc.

Wyeth Canada