Important Safety Information

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over 24; there was a reduction in risk with antidepressant use in patients aged 65 and older.
In patients of all ages who are started on antidepressant therapy, monitor closely for clinical worsening and emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber. Effexor XR is not approved for use in pediatric patients.
  • Effexor XR is contraindicated in patients with a known hypersensitivity to venlafaxine hydrochloride, desvenlafaxine succinate, or any excipients in the Effexor XR formulation
  • The use of monoamine oxidase inhibitors (MAOIs) (intended to treat psychiatric disorders) concomitantly with Effexor XR or within 7 days of discontinuing treatment with Effexor XR is contraindicated because of an increased risk of serotonin syndrome. Additionally, the use of Effexor XR within 14 days of discontinuing treatment with an MAOI (intended to treat psychiatric disorders) is also contraindicated
    Starting Effexor XR in a patient who is being treated with an MAOI such as linezolid or intravenous methylene blue is also contraindicated, because of an increased risk of serotonin syndrome
  • 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
  • Effexor XR is not approved for use in bipolar depression. Prior to initiating treatment with an antidepressant, patients should be adequately screened to determine if they are at risk for bipolar disorder
  • Development of potentially life-threatening serotonin syndrome has been reported with SNRIs and SSRIs, including Effexor XR alone, but particularly with concomitant use of serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, and St. John’s wort) and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and others, such as linezolid or intravenous methylene blue). If concomitant use of Effexor XR with other serotonergic drugs is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases. Patients should be made aware of the potential risk of serotonin syndrome
  • In controlled trials, there were dose-related increases in systolic and diastolic blood pressure, as well as cases of sustained hypertension
  • Monitor blood pressure before initiating treatment with Effexor XR and regularly during treatment. Control pre-existing hypertension before initiating treatment with Effexor XR. Use caution in treating patients with pre-existing hypertension or cardiovascular or cerebrovascular conditions that might be compromised by increases in blood pressure. Sustained blood pressure elevation can lead to adverse outcomes. Cases of elevated blood pressure requiring immediate treatment have been reported with Effexor XR. Consider dose reduction or discontinuation of treatment for patients who experienced a sustained increase in blood pressure
  • SSRIs and SNRIs, including Effexor XR, may increase the risk of bleeding events, ranging from ecchymoses, hematomas, epistaxis, petechiae, and gastrointestinal hemorrhage to life-threatening hemorrhage. Concomitant use of aspirin, NSAIDs, and warfarin, and other anti- coagulants or other drugs known to affect platelet function may add to this risk
  • The pupillary dilation that occurs following use of many antidepressant drugs including Effexor XR may trigger an angle closure attack in a patient with anatomically narrow angles (Angle Closure Glaucoma) who does not have a patent iridectomy
  • As with all antidepressants, Effexor XR should be used cautiously in patients with a history or family history of mania or hypomania
  • 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
  • Effexor XR, like many antidepressants, should be used cautiously in patients with a history of seizures and should be discontinued in any patient who develops seizures
  • Hyponatremia can occur as a result of treatment with SSRIs and SNRIs, including Effexor XR. Consider discontinuation of Effexor XR in patients with symptomatic hyponatremia
  • Interstitial lung disease and eosinophilic pneumonia associated with venlafaxine therapy have been rarely reported
  • The most commonly observed adverse reactions in Effexor XR-treated patients in MDD, GAD, SAD, and PD (incidence ≥ 5% and at least twice the rate of placebo) were nausea (30.0%), somnolence (15.3%), dry mouth (14.8%), sweating (11.4%), abnormal ejaculation (9.9%), anorexia (9.8%), constipation (9.3%), impotence (5.3%), and decreased libido (5.1%)
  • 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
Indications
Effexor XR extended-release capsules are indicated for the treatment of Major Depressive Disorder (MDD), Generalized Anxiety Disorder (GAD), Social Anxiety Disorder (SAD), and Panic Disorder (PD) with or without agoraphobia.