Further evaluation may be required, including referral. Careful observation for digital changes is necessary during treatment with stimulants. Signs and symptoms are usually intermittent and mild very rare sequelae include digital ulceration and/or soft tissue breakdown. CNS stimulants, including Vyvanse, are associated with peripheral vasculopathy, including Raynaud’s phenomenon.Vyvanse is not approved for use in pediatric patients below 6 years of age. Treatment may need to be interrupted in pediatric patients not growing or gaining weight as expected.
CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients with ADHD (monitor weight and height). New Psychotic or Manic Symptoms: At recommended doses, may cause psychotic or manic symptoms (e.g., hallucinations, delusional thinking, or mania) in patients with no prior history of psychotic illness or mania. Prior to initiating treatment, screen for risk factors for developing a manic episode (e.g., comorbid or history of depressive symptoms, or a family history of suicide, bipolar disorder, and depression). Induction of a Manic Episode in Patients with Bipolar Disorder: May induce a mixed/manic episode in patients with bipolar disorder. Exacerbation of Pre-existing Psychosis: May exacerbate symptoms of behavior disturbance and thought disorder in patients with a pre-existing psychotic disorder. Monitor all patients for tachycardia and hypertension. CNS stimulants cause increases in blood pressure (mean increase about 2-4 mm Hg) and heart rate (mean increase about 3-6 bpm). Further evaluate patients who develop exertional chest pain, unexplained syncope, or arrhythmias while taking Vyvanse. Sudden death, stroke and myocardial infarction have been reported in adults with CNS stimulants at recommended doses, as well as sudden death in pediatric patients with structural cardiac abnormalities and other serious heart problems while taking CNS stimulants at recommended doses. Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart arrhythmia, coronary artery disease, and other serious heart problems. Prior to and during treatment assess for the presence of cardiac disease. Use with monoamine oxidase inhibitors (MAOIs) or within 14 days of stopping MAOIs (including MAOIs such as linezolid or intravenous methylene blue), because of an increased risk of hypertensive crisis. Anaphylactic reactions, Stevens-Johnson Syndrome, angioedema, and urticaria have occurred. Known hypersensitivity to amphetamines or other ingredients of Vyvanse.
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