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Important Treatment Considerations

Suicidality and Antidepressant Drugs

Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of EFFEXOR XR(venlafaxine HCl) or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. EFFEXOR XR is not approved for use in pediatric patients. (See Warnings: Clinical Worsening and Suicide Risk, Precautions: Information for Patients, and Precautions: Pediatric Use.)

  • EFFEXOR XR is contraindicated in patients taking monoamine oxidase inhibitors (MAOIs). EFFEXOR XR should not be used in combination with an MAOI or within at least 14 days of discontinuing treatment with an MAOI because of potential for serious adverse reactions. Based on the half-life of EFFEXOR XR, at least 7 days should be allowed after stopping EFFEXOR XR before starting an MAOI.
  • Adult and pediatric patients with MDD can experience worsening of their depression and/or the emergence of suicidal ideation and behavior, whether or not they are taking antidepressants. All patients treated with antidepressants should be monitored appropriately and observed closely for clinical worsening and suicidality, especially at the beginning of drug therapy, or at the time of increases or decreases in dose. Anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia, hypomania, and mania have been reported and may represent precursors to emerging suicidality. Stopping or modifying therapy should be considered especially when symptoms are severe, abrupt in onset, or not part of presenting symptoms.
  • The development of potentially life-threatening serotonin syndrome may occur when EFFEXOR XR is coadministered with other drugs that may affect the serotonergic neurotransmitter systems. Concomitant use of EFFEXOR XR with MAOIs is contraindicated. If concomitant use of EFFEXOR XR with an SSRI, SNRI, or a triptan is clinically warranted, careful observation of the patient is advised. Concomitant use of EFFEXOR XR with tryptophan supplements is not recommended.
  • Treatment with venlafaxine is associated with sustained increases in blood pressure (BP) in some patients. Three percent of EFFEXOR XR patients in MDD studies (doses of 75 to 375 mg/day), 0.5% in generalized anxiety disorder (GAD) studies (doses of 37.5 to 225 mg/day), 0.6% in social anxiety disorder (SAD) studies (doses of 75 to 225 mg/day), and 0.9% in panic disorder (PD) studies (doses of 75 to 225 mg/day) had sustained BP elevations. Experience with immediate-release venlafaxine in MDD studies showed that sustained hypertension was dose related, increasing from 3% to 7% at doses of 100 to 300 mg/day, to 13% at doses above 300 mg/day. Postmarketing cases of elevated BP requiring immediate treatment have been reported. Pre-existing hypertension should be controlled. Regular BP monitoring is recommended.
  • SSRIs and SNRIs, including EFFEXOR XR, may increase the risk of bleeding events. Concomitant use of aspirin, NSAIDs, warfarin, and other anticoagulants may add to this risk.
  • Mydriasis has been reported in association with venlafaxine; therefore, patients with raised intraocular pressure or those at risk of acute narrow-angle glaucoma (angle-closure glaucoma) should be monitored.
  • Abrupt discontinuation or dose reduction has been associated with discontinuation symptoms. Patients should be counseled on possible discontinuation symptoms and monitored while discontinuing the drug; the dose should be tapered gradually. See the Precautions section of the Prescribing Information.
  • The most common adverse events reported in EFFEXOR XR short-term placebo-controlled MDD, GAD, SAD, and/or PD trials (incidence ≥10% and ≥2x that of placebo) were anorexia, asthenia, constipation, dizziness, dry mouth, ejaculation problems, impotence, insomnia, nausea, nervousness, somnolence, and sweating.
  • As with any psychotropic drug, EFFEXOR XR may impair judgment, thinking, or motor skills; patients should be advised to exercise caution until they have adapted to therapy.
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