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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 are 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 are 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 and serotonergic agents 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, 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 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 studies did not show an increase in the risk of suicidal...
warnings and cautions table
Table 1:Age RangeDrug-Placebo Difference in Number of Cases of Suicidality per 1,000 Patients TreatedIncreases Compared to Placebo< 1814 additional cases18 to 245 additional casesDecreases Compared to Placebo25 to 641 fewer case≥ 656 fewer cases
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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 [see Warnings and Precautions ( 5.11 )] Most common adverse reactions (incidence ≥ 5% and twice the rate of placebo in the 50 mg 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 Hikma Pharmaceuticals USA Inc. at 1-800-962-8364 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 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; 2,116 were exposed to desvenlafaxine 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 patients with MDD, 1,834 patients were exposed to desvenlafaxine (50 mg to 400 mg). Of the 1,834 patients, 12% discontinued treatment due t...
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 ReactionDesvenlafaxineSystem Organ Class Preferred TermPlacebo(n=636)50 mg(n=317)100 mg(n=424)200 mg(n=307)400 mg(n=317)Cardiac disorders Blood pressure increased11122Gastrointestinal disorders Nausea 1022263641 Dry mouth 911172125 Constipation 4991014 Vomiting 33469General disorders and administration site conditions Fatigue 4771011 Chills 11< 134 Feeling jittery 11233Metabolism and nutrition disorders Decreased appetite 2581010Nervous system disorders Dizziness 513101516 Somnolence 4491212 Tremor 22399 Disturbance in attention< 1< 1121Psychiatric disorders Insomnia 69121415 Anxiety 23544 Nervousness 1< 11