WARNING: Suicidality and Antidepressants
See full Prescribing Information for complete boxed warning.
Increased risk of suicidal thinking and behavior has been reported in children, adolescents and young adults taking antidepressants for major depressive disorder (MDD) and other psychiatric disorders. Venlafaxine Extended Release Tablets are not approved for use in pediatric patients.
Venlafaxine Extended Release Tablets (venlafaxine hydrochloride) are indicated for the treatment of Major Depressive Disorder (MDD) and Social Anxiety Disorder (SAD). Efficacy of venlafaxine HCl was shown in both short-term trials and a longer-term trial in MDD, and in short-term SAD trials. Venlafaxine Extended Release Tablets are contraindicated in patients taking monoamine oxidase inhibitors (MAOIs).
All patients 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. Such monitoring should include daily observation by families and caregivers for emergence of agitation, irritability, unusual changes in behavior, or emergence of suicidality.
Venlafaxine Extended Release Tablets should not be used in combination with an MAOI, or within at least 14 days of discontinuing treatment with an MAOI. At least 7 days should be allowed after stopping Venlafaxine Extended Release Tablets before starting an MAOI.
The development of a potentially life-threatening serotonin syndrome or Neuroleptic Malignant Syndrome (NMS)-like reactions have been reported with SSRIs and SNRIs (including Venlafaxine Extended Release Tablets) alone, but particularly if used concomitantly with serotonergic drugs (including triptans), MAO inhibitors, or with antipsychotics or other dopamine antagonists. Severe serotonin syndrome can resemble NMS, and patients should be monitored for symptoms of these disorders. If symptoms develop, Venlafaxine Extended Release Tablets and any serotonergic or antidopaminergic agents, including antipsychotics, should be discontinued immediately.
Treatment with venlafaxine hydrochloride is associated with sustained hypertension in some patients. Regular blood pressure monitoring is recommended. Mydriasis has been reported in association with venlafaxine; therefore, patients with raised intraocular pressure or those at risk of acute narrow-angle glaucoma should be monitored.
Dosing must be individualized according to the patient's hepatic and renal function status. Abrupt discontinuation or dose reduction has been associated with
discontinuation symptoms (generally self-limiting; serious symptoms possible). A gradual reduction in the dose rather than abrupt cessation is recommended.
After treatment with venlafaxine hydrochloride, insomnia and nervousness, activation of mania/hypomania, symptomatic hyponatremia, seizures, abnormal bleeding (most commonly ecchymosis), clinically relevant increases in serum cholesterol, interstitial lung disease and eosinophilic pneumonia have been reported. Venlafaxine Extended Release Tablets should be used cautiously in patients with a history of seizures. Measurement of serum cholesterol should be considered during long-term treatment. Patients should be cautioned about the risk of bleeding associated with concomitant use of Venlafaxine Extended Release Tablets and NSAIDs, aspirin, or other drugs that affect coagulation.
Venlafaxine Extended Release Tablets should be used during pregnancy and nursing only if clearly needed due to the potential for serious adverse reactions.
Adverse reactions occurring in short-term studies of major depressive disorder* were abnormal ejaculation, gastrointestinal complaints (nausea, dry mouth, anorexia), CNS complaints (dizziness, somnolence, abnormal dreams) and sweating. Adverse reactions occurring in short-term studies of social anxiety disorder* were asthenia, gastrointestinal complaints (anorexia, dry mouth, nausea), CNS complaints (anxiety, insomnia, libido decreased, nervousness, somnolence, dizziness), abnormalities of sexual function (abnormal ejaculation, orgasmic dysfunction, impotence), yawn, sweating, and abnormal vision.
*Occurring in at least 5% of patients receiving venlafaxine extended release capsules and at a rate at least twice that of placebo.
Please see full Prescribing Information, including complete boxed warning.
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
