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adverse reactions
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: Suicidal Thoughts and Behaviors in Adolescents and Young Adults [see Warnings and Precautions ( 5.1 )] Serotonin Syndrome [see Warnings and Precautions ( 5.2 )] Discontinuation Syndrome [see Warnings and Precautions ( 5.3 )] Seizures [see Warnings and Precautions ( 5.4 )] Activation of Mania or Hypomania [see Warnings and Precautions ( 5.5 )] Hyponatremia [see Warnings and Precautions ( 5.6 )] Increased Risk of Bleeding [see Warnings and Precautions ( 5.7 )] Interference with Cognitive and Motor Performance [see Warnings and Precautions ( 5.8 )] Angle Closure Glaucoma [see Warnings and Precautions ( 5.9 )] Use in Patients with Concomitant Illness [see Warnings and Precautions ( 5.10 )] Sexual Dysfunction [see Warnings and Precautions ( 5.11 )] Most common adverse reactions (≥ 5% and at least twice the incidence of placebo) are: insomnia, ejaculation disorder (primarily ejaculatory delay), nausea, increased sweating, fatigue and somnolence, decreased libido, and anorgasmia ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Almatica Pharma LLC at 1-877-447-7979 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. The safety of Escitalopram Capsules 15 mg once daily for the treatment of major depressive disorder (MDD) in adults younger than 65 years of age and pediatric patients 12 years of age and older and for the treatment of generalized anxiety disorder (GAD) in adults younger than 65 years of age is based upon adequate and well-controlled studies of another escitalopram product with dosing ranging from 10 to 20 mg once daily. The results of these adequate and well-controlled studies are presented below. Clinical Trial Data Sources Adults Adverse reaction data in adults with MDD were collected from 715 patients who were exposed to escitalopram and from 592 patients who were exposed to placebo in double-blind, placebo-controlled trials. An additional 284 adults with MDD were newly exposed to escitalopram in open-label trials. The adverse reaction data in adults with GAD were collected from 429 patients exposed to escitalopram and from 427 patients exposed to placebo in double-blind, placebo-controlled trials. Pediatric Patients Adverse reaction data for pediatric patients with MDD were collected in double-blind placebo-controlled studies in 576 pediatric patients 6 to 17 years of age, (286 escitalopram, 290 placebo). The safety and effectiveness of Escitalopram Capsules have not been established in pediatric patients less than 12 years of age with MDD. Adverse Reactions Associated with Discontinuation of Treatment Major Depressive Disorder in Adults Among the 715 adults with MDD who received escitalopram in placebo-controlled trials, 6% discontinued treatment due to an adverse reaction, as compared to 2% of 592 patients receiving placebo. The rate of discontinuation for adverse reactions in patients assigned to a fixed dose of 20 mg/day escitalopram was 10%, which was significantly different from the rate of discontinuation for adverse reactions in patients receiving 10 mg/day escitalopram (4%) and placebo (3%). Adverse reactions that were associated with discontinuation in at least 1% of escitalopram-treated patients, and at least twice that of placebo, were nausea (2%) and ejaculation disorder (2% of male patients). Major Depressive Disorder in Pediatric Patients In pediatric patients 6 to 17 years of age with MDD, adverse reactions were associated with discontinuation in 3.5% of 286 patients receiving escitalopram and 1% of 290 patients receiving placebo. The most common adverse reaction (incidence at least 1% for escitalopram and greater than placebo) associated with discontinuation was insomnia (1% escitalopram, 0% placebo). The safety and effectiveness of Escitalopram Capsules have not been established in pediatric patients less than 12 years of age with MDD. Generalized Anxiety Disorder in Adults Among the 429 adults with GAD who received escitalopram 10 to 20 mg/day in placebo-controlled trials, 8% discontinued treatment due to an adverse reaction, as compared to 4% of 427 patients receiving placebo. Adverse reactions that were associated with discontinuation in at least 1% of escitalopram-treated patients and at least twice the placebo rate were nausea (2%), insomnia (1%), and fatigue (1%). Additional pediatric use information is approved for AbbVie Inc.’s LEXAPRO (escitalopram) tablets and LEXAPRO (escitalopram) oral solution. However, due to AbbVie Inc.’s marketing exclusivity rights, this drug product is not labeled with that information. Incidence of Adverse Reactions in Placebo-Controlled Clinical Trials Major Depressive Disorder in Adults The most commonly observed adverse reactions in escitalopram-treated adults with MDD (incidence of approximately 5% or greater and approximately twice the placebo rate) were insomnia, ejaculation disorder (primarily ejaculatory delay), nausea, increased sweating, fatigue, and somnolence. Table 2 enumerates the incidence, rounded to the nearest percent, of adverse reactions that occurred among 715 adults with MDD who received escitalopram at doses ranging from 10 to 20 mg/day in placebo-controlled trials. Reactions included are those occurring in 2% or more of escitalopram-treated patients and greater than the incidence in placebo-treated patients. Table 2: Adverse Reactions (≥ 2% and greater than placebo) for Major Depressive Disorder in Adults in Placebo-Controlled Trials 1 Primarily ejaculatory delay. 2 Denominator used was for males only (N=225 escitalopram; N=188 placebo). 3 Denominator used was for females only (N=490 escitalopram; N=404 placebo). Adverse Reaction Escitalopram Placebo (N=715) % (N=592) % Autonomic Nervous System Disorders Dry Mouth 6 5 Sweating Increased 5 2 Central & Peripheral Nervous System Disorders Dizziness 5 3 Gastrointestinal Disorders Nausea 15 7 Diarrhea 8 5 Constipation 3 1 Indigestion 3 1 Abdominal Pain 2 1 General Influenza-like Symptoms 5 4 Fatigue 5 2 Psychiatric Disorders Insomnia 9 4 Somnolence 6 2 Appetite Decreased 3 1 Libido Decreased 3 1 Respiratory System Disorders Rhinitis 5 4 Sinusitis 3 2 Urogenital Ejaculation Disorder 1,2 9 <1 Impotence 2 3 <1 Anorgasmia 3 2 <1 Major Depressive Disorder in Pediatric Patients The overall profile of adverse reactions in pediatric patients 6 to 17 years of age with MDD was generally similar to that seen in adult studies, as shown in Table 2. However, the following adverse reactions (excluding those which appear in Table 2 and those for which the coded terms were uninformative or misleading) were reported at an incidence of at least 2% for escitalopram and greater than placebo: back pain, urinary tract infection, vomiting, and nasal congestion. The safety and effectiveness of Escitalopram Capsules have not been established in pediatric patients less than 12 years of age with MDD. Generalized Anxiety Disorder in Adults The most commonly observed adverse reactions in escitalopram-treated adults with GAD (incidence of approximately 5% or greater and approximately twice the placebo rate) were nausea, ejaculation disorder (primarily ejaculatory delay), insomnia, fatigue, decreased libido, and anorgasmia. Table 3 enumerates the incidence, rounded to the nearest percent of adverse reactions that occurred among 429 escitalopram-treated adults with GAD who received 10 to 20 mg/day in placebo-controlled trials. Reactions included are those occurring in 2% or more of escitalopram-treated patients and for which the incidence was greater than the incidence in placebo-treated patients. Table 3: Adverse Reactions (≥ 2% and greater than placebo) for Generalized Anxiety Disorder in Adults in Placebo-Controlled Trials 1 Primarily ejaculatory delay. 2 Denominator used was for males only (N=182 escitalopram; N=195 placebo). 3 Denominator used was for females only (N=247 escitalopram; N=232 placebo). Adverse Reactions Escitalopram Placebo (N=429) % (N=427) % Autonomic Nervous System Disorders Dry Mouth 9 5 Sweating Increased 4 1 Central & Peripheral Nervous System Disorders Headache 24 17 Paresthesia 2 1 Gastrointestinal Disorders Nausea 18 8 Diarrhea 8 6 Constipation 5 4 Indigestion 3 2 Vomiting 3 1 Abdominal Pain 2 1 Flatulence 2 1 Toothache 2 0 General Fatigue 8 2 Influenza-like Symptoms 5 4 Musculoskeletal System Disorder Neck/Shoulder Pain 3 1 Psychiatric Disorders Somnolence 13 7 Insomnia 12 6 Libido Decreased 7 2 Dreaming Abnormal 3 2 Appetite Decreased 3 1 Lethargy 3 1 Respiratory System Disorders Yawning 2 1 Urogenital Ejaculation Disorder 1,2 14 2 Anorgasmia 3 6 <1 Menstrual Disorder 2 1 Additional pediatric use information is approved for AbbVie Inc’s LEXAPRO (escitalopram) tablets and LEXAPRO (escitalopram) oral solution. However, due to AbbVie Inc’s marketing exclusivity rights, this drug product is not labeled with that information. Dose Dependency of Adverse Reactions The potential dose dependency of common adverse reactions (defined as an incidence rate of ≥5% in either the 10 mg or 20 mg escitalopram groups) was examined on the basis of the combined incidence of adverse reactions in two fixed-dose trials. The overall incidence rates of adverse reactions in 10 mg/day escitalopram-treated patients (66%) were similar to that of the placebo-treated patients (61%), while the incidence rate in 20 mg/day escitalopram-treated patients was greater (86%). Table 4 shows common adverse reactions that occurred in the 20 mg/day escitalopram group with an incidence that was approximately twice that of the 10 mg/day escitalopram group and approximately twice that of the placebo group. Table 4: Dose Dependency of Common Adverse Reactions in Patients with Major Depressive Disorder* *Adverse reactions in the 20 mg/day escitalopram group occurred with an approximate incidence of twice the 10 mg/day escitalopram group and approximately twice that of placebo. **Escitalopram Capsules are available only as a 15 mg dosage strength. Adverse Reaction Placebo (N=311) 10 mg/day Escitalopram** (N=310) 20 mg/day Escitalopram** (N=125) Insomnia 4% 7% 14% Diarrhea 5% 6% 14% Dry Mouth 3% 4% 9% Somnolence 1% 4% 9% Sweating Increased <1% 3% 8% Dizziness 2% 4% 7% Constipation 1% 3% 6% Fatigue 2% 2% 6% Indigestion 1% 2% 6% Male and Female Sexual Dysfunction with SSRIs Although changes in sexual desire, sexual performance, and sexual satisfaction often occur as manifestations of a psychiatric disorder, they may also be a consequence of SSRI treatment. However, reliable estimates of the incidence and severity of untoward experiences involving sexual desire, performance, and satisfaction are difficult to obtain, in part because patients and healthcare providers may be reluctant to discuss them. Accordingly, estimates of the incidence of untoward sexual experience and performance cited in product labeling are likely to underestimate their actual incidence. Table 5: Incidence of Sexual Adverse Reactions in Males or Females in Placebo-Controlled Clinical Trials Adverse Reaction Escitalopram Placebo Males Only (N=407) % (N=383) % Ejaculation Disorder (primarily ejaculatory delay) 12 1 Libido Decreased 6 2 Impotence 2 <1 Females Only (N=737) % (N=636) % Libido Decreased 3 1 Anorgasmia 3 <1 There are no adequately designed studies examining sexual dysfunction with escitalopram treatment. Priapism has been reported with all SSRIs. Weight Changes Patients treated with escitalopram in controlled trials did not differ from placebo-treated patients with regard to clinically important change in body weight. ECG Changes Electrocardiograms from another escitalopram product (N=625) and placebo (N=527) groups were compared with respect to outliers defined as subjects with QTc changes over 60 msec from baseline or absolute values over 500 msec post-dose, and subjects with heart rate increases to over 100 bpm or decreases to less than 50 bpm with a 25% change from baseline (tachycardic or bradycardic outliers, respectively). None of the patients in the escitalopram group had a QTcF interval >500 msec or a prolongation >60 msec compared to 0.2% of patients in the placebo group. The incidence of tachycardic outliers was 0.2% in the escitalopram and the placebo group. The incidence of bradycardic outliers was 0.5% in the escitalopram group and 0.2% in the placebo group. Other Reactions Observed During the Premarketing Evaluation of Escitalopram Capsules Other adverse reactions at an incidence of ≥1% and greater than placebo reported by the 1428 patients treated with another escitalopram product for periods of up to one year in double-blind or open-label clinical trials are shown below. The following list does not include adverse reactions 1) already listed in previous tables or elsewhere in the labeling, 2) for which a drug cause was remote, 3) which were so general as to be uninformative, 4) which were not considered to have clinically significant implications, or 5) which occurred at a rate equal to or less than placebo. Cardiovascular: hypertension, palpitation. Central and Peripheral Nervous System Disorders: light-headed feeling, migraine. Gastrointestinal Disorders: abdominal cramp, heartburn, gastroenteritis. General: allergy, chest pain, fever, hot flushes, pain in limb. Metabolic and Nutritional Disorders: increased weight. Musculoskeletal System Disorders: arthralgia, myalgia jaw stiffness. Psychiatric Disorders: appetite increased, concentration impaired, irritability. Reproductive Disorders/Female: menstrual cramps, menstrual disorder. Respiratory System Disorders: bronchitis, coughing, nasal congestion, sinus congestion, sinus headache. Skin and Appendages Disorders: rash. Special Senses: vision blurred, tinnitus. Urinary System Disorders: urinary frequency, urinary tract infection. 6.2 Post-Marketing Experience The following adverse reactions have been identified during post-approval use of another escitalopram product. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Blood and Lymphatic System Disorders : anemia, agranulocytis, aplastic anemia, hemolytic anemia, idiopathic thrombocytopenia purpura, leukopenia, thrombocytopenia. Cardiac Disorders : atrial fibrillation, bradycardia, cardiac failure, myocardial infarction, tachycardia, torsade de pointes, ventricular arrhythmia, ventricular tachycardia. Ear and Labyrinth Disorders : vertigo Endocrine Disorders : diabetes mellitus, hyperprolactinemia, SIADH. Eye Disorders : angle closure glaucoma, diplopia, mydriasis, visual disturbance. Gastrointestinal Disorder : dysphagia, gastrointestinal hemorrhage, gastroesophageal reflux, pancreatitis, rectal hemorrhage. General Disorders and Administration Site Conditions : abnormal gait, asthenia, edema, fall, feeling abnormal, malaise. Hepatobiliary Disorders : fulminant hepatitis, hepatic failure, hepatic necrosis, hepatitis. Immune System Disorders : allergic reaction, anaphylaxis. Investigations : bilirubin increased, decreased weight, electrocardiogram QT prolongation, hepatic enzymes increased, hypercholesterolemia, INR increased, prothrombin decreased. Metabolism and Nutrition Disorders : hyperglycemia, hypoglycemia, hypokalemia, hyponatremia. Musculoskeletal and Connective Tissue Disorders : muscle cramp, muscle stiffness, muscle weakness, rhabdomyolysis. Nervous System Disorders : akathisia, amnesia, ataxia, choreoathetosis, cerebrovascular accident, dysarthria, dyskinesia, dystonia, extrapyramidal disorders, grand mal seizures (or convulsions), hypoaesthesia, myoclonus, nystagmus, Parkinsonism, restless legs, seizures, syncope, tardive dyskinesia, tremor. Pregnancy, Puerperium and Perinatal Conditions : spontaneous abortion. Psychiatric Disorders : acute psychosis, aggression, agitation, anger, anxiety, apathy, completed suicide, confusion, depersonalization, depression aggravated, delirium, delusion, disorientation, feeling unreal, hallucinations (visual and auditory), mood swings, nervousness, nightmare, panic reaction, paranoia, restlessness, self-harm or thoughts of self-harm, suicide attempt, suicidal ideation, suicidal tendency. Renal and Urinary Disorders : acute renal failure, dysuria, urinary retention. Reproductive System and Breast Disorders : menorrhagia, priapism. Respiratory, Thoracic and Mediastinal Disorders : anosmia, dyspnea, epistaxis, pulmonary embolism, hyposmia, pulmonary hypertension of the newborn. Skin and Subcutaneous Tissue Disorders : alopecia, angioedema, dermatitis, drug reaction with eosinophilia and systemic symptoms (DRESS), ecchymosis, erythema multiforme, photosensitivity reaction, Stevens Johnson Syndrome, toxic epidermal necrolysis, urticaria. Vascular Disorders : deep vein thrombosis, flushing, hypertensive crisis, hypotension, orthostatic hypotension, phlebitis, thrombosis.