my personal edition > depression > news


  E-Mail this DGNews to a colleague

DGNews

Health Canada Warns of Venlafaxine Overdosage, Increased Risk of Fatal Outcome

OTTOWA, Ontario -- October 30, 2008 -- Health Canada, along with the manufacturers of extended release (XR) venlafaxine capsules, are informing healthcare professionals of an association between venlafaxine XR overdosage and the increased risk of fatal outcome compared with that observed with selective serotonin reuptake inhibitor (SSRI) antidepressants, but lower than that of 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, 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.

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.

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. The manufacturers of venlafaxine XR include Cobalt Pharmaceuticals Inc., Genpharm, Laboratoire Riva Inc., Novopharm Limited, Pharmascience Inc., ratiopharm, Sandoz Canada Inc., and Wyeth Canada.

For a complete list of the manufacturer's addresses and phone numbers, please see: http://www.hc-sc.gc.ca/dhp-mps/alt_formats/hpfb-dgpsa/pdf/medeff/venlaflaxine_hpc-cps-eng.pdf

SOURCE: Health Canada

E-Mail this DGNews to a colleague

To print, use this version