Warning on ADHD drug Strattera, used in children & adolscents.

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IMPORTANT SAFETY INFORMATION ON STRATTERA FOR CHILDREN AGED 6 AND OLDER, TEENS, AND ADULTShttp://www.medscape.com/infosite/strattera#safety?src=0_nl_sm_0

 

Suicidal Ideation in Children and Adolescents

Strattera

(atomoxetine) increased the risk of suicidal ideation in short-term

studies in children or adolescents with Attention-Deficit/Hyperactivity

Disorder (ADHD). Anyone considering the use of Strattera in a child or

adolescent must balance this risk with the clinical need. Patients who

are started on therapy should be monitored closely for suicidality

(suicidal thinking and behavior), clinical worsening, or unusual

changes in behavior. Families and caregivers should be advised of the

need for close observation and communication with the prescriber.

Strattera is approved for ADHD in pediatric and adult patients.

Strattera is not approved for major depressive disorder.

Pooled

analyses of short-term (6 to 18 weeks) placebo-controlled trials of

Strattera in children and adolescents (a total of 12 trials involving

over 2200 patients, including 11 trials in ADHD and 1 trial in

enuresis) have revealed a greater risk of suicidal ideation early

during treatment in those receiving Strattera compared to placebo. The

average risk of suicidal ideation in patients receiving Strattera was

0.4% (5/1357 patients), compared to none in placebo-treated patients

(851 patients). No suicides occurred in these trials.

 

Strattera should not be taken within 2 weeks of taking an MAOI and is contraindicated in patients with narrow-angle glaucoma.All

pediatric patients being treated with Strattera should be monitored

closely for suicidality, clinical worsening, and unusual changes in

behavior, especially during the initial few months of a course of drug

therapy, or at times of dose changes. Consideration should be given to

changing the therapeutic regimen, including possibly discontinuing the

medication, in patients who are experiencing emergent suicidality or

symptoms that might be precursors to emerging suicidality, especially

if these symptoms are severe or abrupt in onset, or were not part of

the patient's presenting symptoms.A similar analysis

in adult patients treated with Strattera for either ADHD or major

depressive disorder (MDD) did not reveal an increased risk of suicidal

ideation or behavior in association with the use of Strattera.Postmarketing

reports indicate that Strattera can cause severe liver injury in rare

cases; although no evidence of liver injury was detected in clinical

trials of about 6000 patients. Strattera should be discontinued in

patients with jaundice or laboratory evidence of liver injury, and

should not be restarted. Laboratory testing to determine liver enzyme

levels should be done upon the first symptom or sign of liver

dysfunction (eg, pruritus, dark urine, jaundice, right upper quadrant

tenderness, or unexplained "flu-like" symptoms).Strattera

should not be used in patients with known serious structural cardiac

abnormalities, cardiomyopathy, serious heart rhythm abnormalities, or

other serious cardiac abnormalities. Treatment emergent

psychotic or manic symptoms in children and adolescents can be caused

by Strattera. Consideration should be given to a possible causal role

of Strattera. Discontinuation of treatment may be appropriate.Rare

postmarketing cases of priapism have been reported in pediatric and

adult patients treated with Strattera. Prompt medical attention is

advised in the event of suspected priapism.Although uncommon, allergic reactions, including angioneurotic edema, urticaria, and rash, have been reported with Strattera.Strattera

should be used with caution in patients with hypertension, hypotension,

tachycardia, or cardiovascular or cerebrovascular disease. A complaint

of urinary retention or urinary hesitancy should be considered

potentially related to Strattera.As with all ADHD

medications, growth should be monitored during treatment, although

height and weight data measured up to 3 years indicates minimal, if

any, long-term effects.In children and adolescents, the

most common adverse events reported in clinical trials were decreased

appetite, nausea, vomiting, fatigue, dyspepsia, dizziness, and mood

swings.* In adults, the most common adverse events reported in clinical

trials were dry mouth, insomnia, nausea, appetite decrease,

constipation, erectile disturbance, dysmenorrhea, dizziness, and libido

decreased.*Anyone considering the use of Strattera in a

child or adolescent must balance the potential risks with the clinical

need. Safety and effectiveness have not been established in pediatric

patients less than 6 years of age or in geriatric patients.

*In clinical trials, adverse events reported in at least 5% of patients and twice the rate of placebo

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