CONCERTA and safety: A favorable profile for short- and long-term use

CONCERTA was generally well tolerated by children and adolescents in controlled clinical trials.

Low incidence of insomnia in children (4%) and adolescents (5%)
Low incidence of loss of appetite in children (4%) and adolescents (2%)
Low incidence of discontinuation due to adverse events was seen in children (<1%) and adolescents (0%)

See the adverse events reported from controlled clinical trials in children and adolescents:

Demonstrated safety for up to 2 years in 229 children

In a long-term, open-label study only 1 patient had a clinically significant change in vital signs and discontinued during month 4 due to elevated blood pressure¹
Minimal effect on growth after 21 months of therapy: patients were a mean 0.23 cm shorter and weighed a mean 1.23 kg less than expected for their ages¹

IMPORTANT SAFETY INFORMATION

Long-term usefulness of treatment should be periodically reevaluated.

Patients should be monitored for changes in blood pressure and heart rate.

Growth should be monitored during treatment to determine if patients are growing and gaining weight as expected, and treatment adjusted as apporpriate.

Reference: 1. Wilens T, McBurnett K, Stein M, Lerner M, Spencer T, Wolraich M. ADHD treatment with once-daily OROS® methylphenidate: final results from a long-term open-label study. J Am Acad Child Adolesc Psychiatry. 2005;44:1015-1023.

CONCERTA^® is indicated for the treatment of attention deficit hyperactivity disorder (ADHD).

IMPORTANT SAFETY INFORMATION

CONCERTA^® should not be taken by patients with: allergies to methylphenidate or other ingredients in CONCERTA^®; significant anxiety, tension, or agitation; glaucoma; Tourette's syndrome, tics, or family history of Tourette's syndrome; current or recent use of monoamine oxidase inhibitors (MAOIs). Children under 6 years of age should not take CONCERTA.^®

Abuse of methylphenidate may lead to dependence. CONCERTA^® should not be used in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, other serious cardiac problems, or patients with pre-existing severe gastrointestinal narrowing. Use with caution in patients with hypertension and other cardiovascular conditions, psychosis, bipolar disorder, and history of seizures/EEG abnormalities. Stimulants may cause new psychotic or manic symptoms; discontinuation of treatment may be appropriate. Aggressive behavior or hostility should be monitored in patients beginning ADHD treatment. Methylphenidate may produce difficulties with visual accommodation and blurring of vision. Hematologic monitoring is advised during prolonged therapy. Growth should be monitored during treatment with stimulants, and patients who are not growing or gaining height or weight as expected may need to have their treatment interrupted.

The most common adverse reaction (>5%) reported in children and adolescents was abdominal pain upper. The most common adverse reactions (>10%) reported in adults were dry mouth, nausea, decreased appetite, headache, and insomnia.

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Last Modified Date: Jan 16 2008 at 16:12:36 EST