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boxed warning
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 age 24; there was a reduction in risk with antidepressant use in patients aged 65 and older [ see Warnings and Precautions (5.1) ]. In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber [ see Warnings and Precautions (5.1) ]. Desvenlafaxine extended-release tablets is not approved for use in pediatric patients [ see Use in Specific Populations (8.4) ]. WARNING: SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning. •Increased the risk of suicidal thoughts and behaviors in children, adolescents and young adults taking antidepressants ( 5.1 ). •Closely monitor for clinical worsening and emergence of suicidal thoughts and behaviors ( 5.1 ). •Desvenlafaxine extended-release tablets is not approved for use in pediatric patients ( 8.4 ).
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warnings and cautions
5 WARNINGS AND PRECAUTIONS . • Serotonin Syndrome: Increased risk when co-administered with other serotonergic agents , but also when taken alone. If it occurs, discontinue desvenlafaxine extended-release tablets and initiate supportive treatment ( 5.2 ). • Elevated Blood Pressure: Control hypertension before initiating treatment. Monitor blood pressure regularly during treatment ( 5.3 ). • Increased Risk of Bleeding: Concomitant use of aspirin, NSAIDs, other antiplatelet drugs, warfarin and other anticoagulants may increase this risk ( 5.4 ). • Angle Closure Glaucoma: Avoid use of antidepressants, including desvenlafaxine extended-release tablets, in patients with untreated anatomically narrow angles treated ( 5.5 ). • Activation of Mania/Hypomania: Use cautiously in patients with Bipolar Disorder. Caution patients about risk of activation of mania/hypomania ( 5.6 ). • Discontinuation Syndrome: Taper dose when possible and monitor for discontinuation symptoms ( 5.7 ). • Seizure: Can occur. Use cautiously in patients with seizure disorder ( 5.8 ). • Hyponatremia: Can occur in association with SIADH ( 5.9 ). • Interstitial Lung Disease and Eosinophilic Pneumonia: Can occur ( 5.10 ). • Sexual Dysfunction: Desvenlafaxine extended-release tablets may cause symptoms of sexual dysfunction (5.11). 5.1 Suicidal Thoughts and Behaviors in Pediatric and Young Adult Patients Patients with MDD, both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. Suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide. There has been a long-standing concern, however, that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients during the early phases of treatment. Pooled analyses of short-term placebo-controlled studies of antidepressant drugs (SSRIs and others) showed that these drugs increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (ages 18 to 24) with major depressive disorder (MDD) and other psychiatric disorders. Short-term studi...
warnings and cautions table
Table 1 Age Range Drug-Placebo Difference in Number of Cases of Suicidality per 1,000 Patients Treated Increases Compared to Placebo < 18 14 additional cases 18 to 24 5 additional cases Decreases Compared to Placebo 25 to 64 1 fewer case ≥ 65 6 fewer case
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adverse reactions
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the label. •Hypersensitivity [ see Contraindications (4) ] •Suicidal Thoughts and Behaviors in Pediatric and Young Adult Patients [ see Warnings and Precautions (5.1) ] •Serotonin Syndrome [ see Warnings and Precautions (5.2) ] •Elevated Blood Pressure [ see Warnings and Precautions (5.3) ] •Increased Risk of Bleeding [ see Warnings and Precautions (5.4) ] •Angle Closure Glaucoma [ see Warnings and Precautions (5.5) ] •Activation of Mania/Hypomania [ see Warnings and Precautions (5.6) ] •Discontinuation Syndrome [ see Warnings and Precautions (5.7) ] •Seizure [see Warnings and Precautions (5.8) ] •Hyponatremia [ see Warnings and Precautions (5.9) ] •Interstitial Lung Disease and Eosinophilic Pneumonia [ see Warnings and Precautions (5.10) ] •Sexual Dysfunction: Desvenlafaxine extended-release tablets may cause symptoms of sexual dysfunction (5.11). Most common adverse reactions (incidence ≥ 5% and twice the rate of placebo in the 50 or 100 mg dose groups) were: nausea, dizziness, insomnia, hyperhidrosis, constipation, somnolence, decreased appetite, anxiety, and specific male sexual function disorders ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Marlex Pharmaceuticals, Inc. at 1-888-582-1953 or Drugsafety@marlexpharm.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in clinical practice. Patient exposure Desvenlafaxine extended-release tablets was evaluated for safety in 8,394 patients diagnosed with major depressive disorder who participated in multiple-dose pre-marketing studies, representing 2,784 patient-years of exposure. Of the total 8,394 patients exposed to at least one dose of desvenlafaxine extended-release tablets; 2,116 were exposed to desvenlafaxine extended-release tablets for 6 months, representing 1,658 patient-years of exposure, and 421 were exposed for one year, representing 416 patient-years of exposure. Adverse reactions reported as reasons for discontinuation of treatment In the pre-marketing pooled 8-week placebo-controlled studies in pat...
adverse reactions table
Table 2: Common Adverse Reactions (≥2% in any Fixed-Dose Group and Twice the Rate of Placebo) in Pre-marketing Pooled MDD 8-Week Placebo-Controlled StudiesPercentage of Patients Reporting ReactionDesvenlafaxine Extended-Release TabletsSystem Organ Class Preferred Term Placebo (n=636) 50 mg (n=317) 100 mg (n=424) 200 mg (n=307) 400 mg (n=317) Cardiac disordersBlood pressure increased11122Gastrointestinal disordersNausea1022263641Dry mouth911172125Constipation4991014Vomiting33469General disorders and administration site conditionsFatigue4771011Chills11<134Feeling jittery11233Metabolism and nutrition disordersDecreased appetite2581010Nervous system disordersDizziness513101516Somnolence4491212Tremor22399Disturbance in attention<1<1121Psychiatric disordersInsomnia69121415Anxiety23544Nervousness1<1122Abnormal dreams12324Renal and urinary disordersUrinary hesitation0<1122Respiratory, thoracic and mediastinal disordersYawning<11143Skin and subcutaneous tissue disordersHyperhidrosis410111821Special SensesVision blurred13444Mydriasis<12266Vertigo12153Tinnitus1211