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STRATTERA (ATOMOXETINE HCL): ADVERSE REACTIONS / SIDE EFFECTS

Clinical Trials Experience

Strattera (Atomoxetine) was administered to 5382 children or adolescent patients with ADHD and 1007 adults with ADHD in clinical studies. During the ADHD clinical trials, 1625 children and adolescent patients were treated for longer than 1 year and 2529 children and adolescent patients were treated for over 6 months.

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 trials of another drug and may not reflect the rates observed in practice.

Child and Adolescent Clinical Trials

Reasons for discontinuation of treatment due to adverse reactions in child and adolescent clinical trials

In acute child and adolescent placebo-controlled trials, 3.0% (48/1613) of atomoxetine subjects and 1.4% (13/945) placebo subjects discontinued for adverse reactions. For all studies, (including open-label and long-term studies), 6.3% of extensive metabolizer (EM) patients and 11.2% of poor metabolizer (PM) patients discontinued because of an adverse reaction. Among Strattera (Atomoxetine) capsules treated patients, irritability (0.3%, N=5); somnolence (0.3%, N=5); aggression (0.2%, N=4); nausea (0.2%, N=4); vomiting (0.2%, N=4); abdominal pain (0.2%, N=4); constipation (0.1%, N=2); fatigue (0.1%, N=2); feeling abnormal (0.1%, N=2); and headache (0.1%, N=2) were the reasons for discontinuation reported by more than 1 patient.

Seizures

Strattera (Atomoxetine HCl) has not been systematically evaluated in pediatric patients with seizure disorder as these patients were excluded from clinical studies during the product's premarket testing. In the clinical development program, seizures were reported in 0.2% (12/5073) of children whose average age was 10 years (range 6 to 16 years). In these clinical trials, the seizure risk among poor metabolizers was 0.3% (1/293) compared to 0.2% (11/4741) for extensive metabolizers.

Commonly observed adverse reactions in acute child and adolescent, placebo-controlled trials

Commonly observed adverse eactions associated with the use of Strattera (incidence of 2% or greater) and not observed at an equivalent incidence among placebo-treated patients (Strattera incidence greater than placebo) are listed below. Results were similar in the BID and the QD trial, which shows both BID and QD results for selected adverse reactions based on statistically significant Breslow-Day tests. The most commonly observed adverse reactions in patients treated with Strattera (incidence of 5% or greater and at least twice the incidence in placebo patients, for either BID or QD dosing) were: vomiting, nausea, fatigue, abdominal pain, decreased appetite, and somnolence.

Common Treatment - Emergent Adverse Reactions Associated with the Use of Strattera (Atomoxetine HCl) capsules

Gastrointestinal Disorders: abdominal pain, vomiting, nausea

General Disorders and Administration Site Conditions: fatigue, irritability, therapeutic response unexpected

Investigations: weight loss

Metabolism and Nutritional Disorders: decreased appetite, anorexia

Nervous System Disorders: headache, somnolence, dizziness

Skin and Subcutaneous Tissue Disorders: rash

Reactions reported by at least 2% of patients treated with Strattera (Atomoxetine Hydrochloride), and greater than placebo. The following reactions did not meet this criterion but were reported by more atomoxetine-treated patients than placebo-treated patients and are possibly related to atomoxetine treatment: early morning awakening, blood pressure increased, flushing, sinus tachycardia, mydriasis, asthenia, mood swings, palpitations, constipation. The following reactions were reported by at least 2% of patients treated with atomoxetine, and equal to or less than placebo: pharyngolaryngeal pain, insomnia (insomnia includes the terms, insomnia, initial insomnia, middle insomnia). The following reaction did not meet this criterion but shows a statistically significant dose relationship: pruritus.

Abdominal pain includes the terms: stomach discomfort, abdominal pain upper, abdominal pain, abdominal discomfort, epigastric discomfort.

Somnolence includes the terms: sedation, somnolence.

Common Treatment-Emergent Adverse Reactions Associated with the Use of Strattera (Atomoxetine Hydrochloride) capsules in Acute (up to 18 weeks) Child and Adolescent Trials

Gastrointestinal Disorders: abdominal pain, vomiting, nausea, constipation

General Disorders: fatigue

Psychiatric Disorders: mood swings

Abdominal pain includes the terms: stomach discomfort, abdominal pain upper, abdominal pain, abdominal discomfort, epigastric discomfort.

Constipation didn't meet the statistical significance on Breslow-Day test but is included in the table because of pharmacologic plausibility.

Mood swings didn't meet the statistical significance on Breslow-Day test at 0.05 level but p-value was < 0.1 (trend).

The following adverse reactions occurred in at least 2% of PM patients and were either twice as frequent or statistically significantly more frequent in PM patients compared with EM patients: insomnia (15% of PMs, 10% of EMs); weight decreased (7% of PMs, 4% of EMs); constipation (7% of PMs, 4% of EMs); depression1 (7% of PMs, 4% of EMs); tremor (5% of PMs, 1% of EMs); excoriation (4% of PMs, 2% of EMs); conjunctivitis (3% of PMs, 1% of EMs); syncope (3% of PMs, 1% of EMs); early morning awakening (2% of PMs, 1% of EMs); mydriasis (2% of PMs, 1% of EMs).

Depression includes the following terms: major depression, depression, depressive symptoms, dysphoria, depressed mood.

Adult Clinical Trials

Reasons for discontinuation of treatment due to adverse reactions in acute adult placebo-controlled trials

In the acute adult placebo-controlled trials 11.3% (61/541) atomoxetine subjects and 3.0% (12/405) placebo subjects discontinued for adverse reactions. Among Atomoxetine (Strattera) treated patients, insomnia (0.9%, N=5); nausea (0.9%, N=5); chest pain (0.6%, N=3); fatigue (0.6%, N=3); anxiety (0.4%, N=2); erectile dysfunction (0.4%, N=2); mood swings (0.4%, N=2); nervousness (0.4%, N=2); palpitations (0.4%, N=2); and urinary retention (0.4%, N=2) were the reasons for discontinuation reported by more than 1 patient.

Seizures

Atomoxetine (Strattera) capsules has not been systematically evaluated in adult patients with a seizure disorder as these patients were excluded from clinical studies during the product's premarket testing. In the clinical development program, seizures were reported on 0.1% (1/748) of adult patients. In these clinical trials, no poor metabolizers (0/43) reported seizures compared to 0.1% (1/705) for extensive metabolizers.

Commonly observed adverse reactions in acute adult placebo-controlled trials

Commonly observed adverse reactions associated with the use of Strattera (incidence of 2% or greater) and not observed at an equivalent incidence among placebo treated patients (Strattera incidence greater than placebo) are listed below. The most commonly observed adverse reactions in patients treated with Strattera (incidence of 5% or greater and at least twice the incidence in placebo patients) were: dry mouth, constipation, nausea, decreased appetite, fatigue, insomnia, erectile dysfunction, urinary hesitation and/or urinary retention and/or dysuria, dysmenorrhea, and hot flush.

Common Treatment-Emergent Adverse Reactions Associated with the Use of Atomoxetine HCl (Strattera) in Acute (up to 25 weeks) Adult Trials

Cardiac Disorders: palpitations

Gastrointestinal Disorders: nausea, dry mouth, constipation, dyspepsia, abdominal pain, vomiting

General Disorders and Administration Site Conditions: chills, fatigue, therapeutic response unexpected, feeling jittery

Investigations: weight loss

Metabolism and Nutritional Disorders: decreased appetite

Nervous System Disorders: somnolence, dizziness, paraesthesia, tremor, sinus headache

Psychiatric Disorders: libido decreased, insomnia, sleep disorder

Renal and Urinary Disorders: dysuria, urinary hesitation and/or urinary retention

Reproductive System and Breast Disorders: dysmenorrhea, erectile dysfunctione, ejaculation delayede and/or ejaculation disorder, menstruation irregular

Skin and Subcutaneous Tissue Disorders: rash, hyperhidrosis

Vascular Disorders: hot flush

Reactions reported by at least 2% of patients treated with atomoxetine, and greater than placebo. The following reactions did not 346 meet this criterion but were reported by more atomoxetine-treated patients than placebo-treated patients and are possibly related to atomoxetine treatment: early morning awakening, tachycardia, peripheral coldness, prostatitis, testicular pain, and orgasm abnormal. The following reactions were reported by at least 2% of patients treated with atomoxetine, and equal to or less than placebo: headache, pharyngolaryngeal pain, irritability.

Abdominal pain includes the terms: abdominal pain upper, abdominal pain, abdominal discomfort, stomach discomfort, epigastric discomfort.

Somnolence includes the terms: sedation, somnolence.

Insomnia includes the terms: initial insomnia, insomnia, middle insomnia.

Based on total number of males (Strattera, N=326; placebo, N=260).

Based on total number of females (Strattera, N=214; placebo, N=142).

Male and female sexual dysfunction

Atomoxetine appears to impair sexual function in some patients. Changes in sexual desire, sexual performance, and sexual satisfaction are not well assessed in most clinical trials because they need special attention and because patients and physicians 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 the actual incidence. The incidence of sexual side effects reported by at least 2% of adult patients taking Strattera (Atomoxetine) in placebo-controlled trials.

There are no adequate and well-controlled studies examining sexual dysfunction with Strattera (Atomoxetine) capsules treatment. While it is difficult to know the precise risk of sexual dysfunction associated with the use of this medication, physicians should routinely inquire about such possible side effects.

Postmarketing Spontaneous Reports

The following adverse reactions have been identified during post approval use of Strattera (Atomoxetine HCl). Unless otherwise specified, these adverse reactions have occurred in adults and children and adolescents. 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.

Cardiovascular system: QT prolongation, syncope.

General disorders and administration site conditions: lethargy.

Nervous system disorders: hypoaesthesia; paraesthesia in children and adolescents; sensory disturbances; tics.

Psychiatric disorders: depression and depressed mood; anxiety.

Seizures: Seizures have been reported in the postmarketing period. The postmarketing seizure cases include patients with pre-existing seizure disorders and those with identified risk factors for seizures, as well as patients with neither a history of nor identified risk factors for seizures. The exact relationship between Strattera (Atomoxetine HCl) capsules and seizures is difficult to evaluate due to uncertainty about the background risk of seizures in ADHD patients.

Skin and subcutaneous tissue disorders: hyperhidrosis.

Urogenital system: Male pelvic pain; urinary hesitation in children and adolescents; urinary retention in children and adolescents.

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