Safety Information Regarding Overdosage of Venlafaxine HCl Extended-Release Capsules - For Health Professionals

Starting date:

October 23, 2008

Posting date:

October 23, 2008

Type of communication:

Dear Healthcare Professional Letter

Subcategory:

Drugs

Source of recall:

Health Canada

Audience:

Healthcare Professionals

Identification number:

RA-170001935

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 appropriate company for a copy of any references, attachments or enclosures.

Notice about Health Canada advisories

Health Canada Endorsed Important Safety Information on VENLAFAXINE XR

October 23, 2008

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

Dear Health Care Professional,

Venlafaxine HCl Extended-Release Capsule manufacturers wish to provide you with important safety information regarding venlafaxine XR. Published retrospective studies^{Footnote 1, Footnote 2, Footnote 3, Footnote 4,} have reported that venlafaxine overdosage may be associated with an increased risk of fatal outcome compared to that observed with Selective Serotonin Reuptake Inhibitor (SSRI) antidepressants, but lower than that for tricyclic antidepressants. Although the extent to which the finding of an increased risk of fatal outcomes can be attributed to the toxicity of venlafaxine in overdosage, as opposed to some characteristics of venlafaxine-treated patients, is not clear,^{Footnote 5} post-market reports of fatal acute overdoses have been received for venlafaxine alone at doses as low as approximately 1 gram.

• Prescriptions for venlafaxine XR should be written for the smallest quantity of drug consistent with good patient management, in order to reduce the risk of overdose, particularly in patients who have more severe illness or risk factors for suicidal behaviour.
• The potential for suicide attempt in seriously depressed patients is inherent to the illness, and may persist until significant remission occurs. Clinical monitoring for suicidal ideation and/or other indicators of suicidal behaviour is recommended for all depressed patients.
• Increased risk of behavioural and emotional changes, including self-harm, has been seen with treatment with venlafaxine, as with other antidepressant drugs, and health care providers, patients, family members and/or caregivers should be vigilant for such changes.
• All antidepressants have a potential risk of fatal outcome in overdose.

Manufacturers of all extended release venlafaxine products are working with Health Canada to include this safety information in the Overdosage section in all Canadian Product Monographs for venlafaxine extended release capsules.

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

Telephone: 613-954-6522

Fax: 613-952-7738

Please contact the appropriate manufacturer with any questions or concerns.

Authorized by:

Cobalt Pharmaceuticals Inc.

Genpharm

Laboratoire Riva Inc.

Novopharm Limited

Pharmascience Inc.

ratiopharm

Sandoz Canada Inc.

Wyeth Canada