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FDA Approves Labeling Change for Vyvanse(R) (lisdexamfetamine dimesylate) Capsules CII to Include Supplemental Data Demonstrating Significant Efficacy at Two Hours Through 14 Hours After Administration in Adults with ADHD
Date:5/4/2010

tamine.  The conversion of Vyvanse to d-amphetamine is not affected by gastrointestinal pH and is unlikely to be affected by alterations in GI transit times.

Sudden death, stroke, and myocardial infarction have been reported in adults taking stimulant drugs at usual doses in ADHD.  Physicians should take a careful patient history, including family history, and physical exam to assess the presence of cardiac disease. Patients who report symptoms of cardiac disease while taking Vyvanse should be promptly evaluated. Use with caution in patients whose underlying medical condition might be affected by an increase in blood pressure or heart rate.

Additional information about Vyvanse and Full Prescribing Information, including the Medication Guide, are available at http://www.vyvanse.com.

INDICATION AND IMPORTANT SAFETY INFORMATION

Vyvanse is indicated for the treatment of ADHD. Efficacy based on two controlled trials in children aged 6 to 12 and two controlled trials in adults. Vyvanse is indicated as an integral part of a comprehensive treatment program that may include other measures (psychological, educational, social).

Amphetamines have a high potential for abuse; prolonged administration may lead to dependence. Misuse of amphetamine may cause sudden death and serious cardiovascular adverse events. See Full Prescribing Information for complete Boxed WARNING.

Vyvanse should not be taken by patients who have advanced arteriosclerosis; symptomatic cardiovascular disease; moderate to severe hypertension; hyperthyroidism; known hypersensitivi
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