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Shire to Initiate Two Phase 4 Clinical Trials to Compare Vyvanse® (lisdexamfetamine dimesylate) Capsules, (CII) to Concerta® (methylphenidate HCl) Extended-Release Tablets, (CII)
Date:3/6/2012

been reported with stimulants at usual doses for the treatment of ADHD. Stimulants generally should not be used in patients with known structural cardiac abnormalities or other serious heart problems. Adults have a greater likelihood than children of having such cardiac disease. Patients being considered for stimulant treatment should have a careful history (including family history of sudden death or ventricular arrhythmia) and physical exam to assess for the presence of cardiac disease. Further evaluation should be conducted if needed (eg, electrocardiogram and echocardiogram). Patients who develop symptoms suggestive of cardiac disease (eg, exertional chest pain, unexplained syncope) during stimulant treatment should undergo a prompt evaluation.

Use with caution in patients whose underlying medical condition might be compromised by increases in blood pressure or heart rate. Stimulants cause modest increases in average blood pressure (about 2-4 mmHg) and average heart rate (about 3-6 bpm) and patients may have larger increases. Monitor all patients for larger changes.

Use of stimulants may cause psychotic or manic symptoms in patients with no prior history, or exacerbation of symptoms in patients with pre-existing psychosis. Clinical evaluation for bipolar disorder is recommended prior to stimulant use. Monitor for aggressive behavior.

Monitor growth in children during treatment with Vyvanse. Children who are not growing (gaining height or weight) as expected may need to have their treatment interrupted.

Stimulants may lower the convulsive threshold. Discontinue if seizures develop.

Visual disturbances and exacerbation of tics and Tourette's syndrome have been reported with stimulant treatment.

The most common adverse reactions (≥5% and at least twice the rate of placebo) reported in clinical trials were:


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