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Safety Information

EFFEXOR®XR Capsules(Venlafaxine Hydrochloride)

Indications and clinical Use:

EFFEXOR XR (venlafaxine hydrochloride) is indicated for the symptomatic relief of:

  • Major Depressive Disorder
  • Anxiety causing clinically significant distress in patients with Generalized Anxiety Disorder
  • Social Anxiety Disorder (Social Phobia)
  • Panic Disorder, with or without agoraphobia, as defined in DSM-IV

Depression: Short-term efficacy has been demonstrated in placebo-controlled trials of up to 12 weeks. Efficacy in maintaining an antidepressant response for up to 26 weeks, following response to 8 weeks of acute treatment, was demonstrated in a placebo-controlled trial.

Generalized Anxiety Disorder: Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The effectiveness in long-term use has been evaluated for up to 6 months in controlled clinical trials.

Social Anxiety Disorder (Social Phobia): Efficacy was demonstrated in four 12-week, multicentre, placebo-controlled, flexible-dose studies and one 6-month, fixed/flexible-dose study in adult outpatients.

Panic Disorder: Efficacy was established in two 12-week, placebo-controlled trials in adult outpatients. The efficacy in prolonging time to relapse for up to 6 months, in responders of a 12-week acute treatment, was demonstrated in a placebo-controlled trial.

The physician who elects to use EFFEXOR XR for extended periods should periodically re-evaluate the long-term usefulness of the drug.

Caution should be exercised in the elderly.

Not indicated for use in children under 18 years of age.

Contraindications:

  • In combination with Monoamine Oxidase Inhibitors (MAOIs) or within two weeks of terminating treatment with MAOIs.

Most serious warnings and precautions:

  • Risk of potential association with behavioural and emotional changes, including self-harm:
    • Rigorous clinical monitoring for suicidal ideation or other indicator of potential for suicidal behaviour is advised in patients of all ages. This includes monitoring for agitation-type emotional and behavioural changes.
    • Patients, families, and caregivers should watch for the emergence of unusual behavioural changes, depression worsening, and suicidal ideation, especially during treatment initiation or change in dose/dose regimen.
  • Discontinuation symptoms: dosage should be tapered gradually and the patient monitored.
  • Bone fractures: increased risk of bone fractures have been shown with some antidepressants, including selective serotonin reuptake inhibitors/serotonin norepinephrine reuptake inhibitors (SSRIs/SNRIs).
  • Hepatic and renal impairment: Dosage adjustments required.

Other relevant warnings and precautions:

  • Risk of allergic reaction
  • Risk of hypertension, including acute severe and sustained hypertension; monitor blood pressure regularly in all patients
  • Caution in the treatment of pregnant women, especially during the third trimester
    • Exposure late in the third trimester may result in discontinuation symptoms and complications requiring prolonged hospitalization, respiratory support and tube feeding
  • Caution in patients operating machinery or engaging in tasks requiring alertness
  • Caution in patients with a history of myocardial infarction or unstable heart disease
  • Increases in heart rate may occur; caution in patients whose underlying conditions may be compromised
  • Risk of QTc prolongation, Torsade de Pointes (TdP)
    • Caution in patients with cardiovascular disease or family history of QT prolongation, or in patients taking medicines known to increase QT interval, especially for patients with increased risk of QT prolongation
  • Caution in patients with diseases or conditions that could affect hemodynamic responses or metabolism
  • Risk of serum cholesterol elevations; monitor levels, especially during long-term treatment
  • Potential for changes in appetite and weight
  • Risk of hyponatremia and syndrome of inappropriate antidiuretic hormone (SIADH) secretion, usually in volume-depleted or dehydrated patients
  • Risk of bleeding; concomitant use with NSAIDs, ASA or other drugs affecting coagulation may add to the risk; caution in patients with a history of bleeding disorder or predisposing conditions
  • Caution in patients with a history of seizures; promptly discontinue if seizure develops
  • Risk of serotonin syndrome or neuroleptic malignant syndrome (NMS)
    • Careful observation if concomitant treatment with other agents affecting serotonergic and/or dopaminergic neurotransmitter systems is clinically warranted
    • Concomitant use with serotonin precursors is not recommended
  • Can cause mydriasis; caution in patients with raised intraocular pressure or narrow angle glaucoma
  • Treatment-emergent insomnia and nervousness
  • Mania/hypomania: caution in patients with a history or family history of bipolar disorder
  • Lactating women should not nurse their infants

For more information:

Please consult the product monograph by clicking here for important information relating to adverse reactions, drug interactions and dosing information which have not been discussed in this site.

EFFEXOR® XR ®Wyeth LLC, owner/Pfizer Canada Inc., Licensee