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Safety Information Regarding Overdosage of Venlafaxine HCl Extended-Release Capsules - For Health Professionals
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(PDF Version - 39 K)Contact: Marketed Health Products Directorate (MHPD)
The Health Products and Food Branch (HPFB) posts on the Health Canada web site safety alerts, public health advisories, press releases and other notices as a service to health professionals, consumers, and other interested parties. These advisories may be prepared with Directorates in the HPFB which includes pre-market and post-market areas as well as market authorization holders and other stakeholders. Although the HPFB grants market authorizations or licenses for therapeutic products, we 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 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.
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 1,2,3,4 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,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
References:
- Shah R, Uren Z. Baker A, Majeed A. Deaths from antidepressants in England and Wales 1993-1997: analysis of a new national database. Psychological Medicine. 2001;31:1203-1210.
- Cheeta S, Schifano F, Oyefeso A, Webb L, Ghodse H. Antidepressant-related deaths and antidepressant prescriptions in England and Wales, 1998-2000. British Journal of Psychiatry. 2004;184:41-47.
- Buckley NA, McManus PR. Fatal toxicity of serotonergic and other antidepressant drugs: analysis of United Kingdom mortality data. BMJ. 2002;325:1332-1333.
- Morgan O, Griffiths C, Baker A. Fatal toxicity of antidepressants in England and Wales, 1993-2002. Health Statistics Quarterly. 2004;23:18-24.
- Mines D, Hill D, Yu H, Novelli L. Prevalence of risk factors for suicide in patients prescribed venlafaxine, fluoxetine and citalopram. Pharmacoepidemiology and Drug Safety. 2005;14:367-372.
