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From: The Makers of ADDERALL XR                              05/05/03 New information Shows that stimulant therapy in children with ADHD may help reduce the risk for future substance use disorder Research suggests that patients with untreated ADHD are at significant risk for future substance use disorder1 The results of two recently published studies demonstrate that in children with ADHD Stimulant treatment results in approximately a 2-fold reduction in the risk for future substance use disorder (SUD)2 Stimulant treatment does not lead to an increased risk for substance use disorder (a finding that corroborates the results of 11 previous studies)3 STUDY RESULTS*: Analysis of studies examining early treatment of children with ADHD (N=1,046) found that Stimulant treatment significantly decreases the risk for subsequent SUD2 Stimulant treatment in childhood was associated with a reduction in the risk for both drug and alcohol use disorders in mid-adolescence2 Stimulant pharmacotherapy for ADHD is not related to an increased risk for subsequent cigarette or tobacco abuse2 "From the public health perspective, given the high prevalence of ADHD in youths and their high risk of developing SUD, the identification and treatment of youths with ADHD may affect a large segment of the adolescent and young adult population culpable to SUD." -Timothy E. Wilens, MD2 "...stimulant treatment was not significantly associated with frequency of any form of drug use..." -Russel A. Barkley, PhD3 "[We] found no relationship between stimulant treatment, either in childhood or in high school, and risk for any DSM-lll-R substance dependance or abuse disorders in adulthood." -Russel A. Barkley, PhD3 "Clinically, the absence of evidence linking SUD with stimulant medication should reassure clinicians and families when discussing the risks and benefits of medication intervention for ADHD." -Timothy E. Wilens, MD2 The most common adverse events include loss of appetite, insomnia, abdominal pain, and emotional lability. As with other psychostimulants indicated for ADHD, there is a potential for exacerbating motor and phonic tics and Tourette's syndrome. A side effect seen with the amphetamine class is psychosis. Caution also should be exercised in patients with a history of psychosis. Abuse of amphetamines may lead to dependance. ADDERALL XR is contradicted in patients with symptomatic cardiovascular disease, moderate to severe hypertension., hyperthyroidism and glaucoma, known hypersensitivity to this class of compounds, agitated states, history of drug abuse, or current or recent use of MAO inhibitors. ADDERALL XR should be prescribed with close physician supervision. References: 1. Biederman J,Wilens T, Mick E, Spencer T, Faraone SV. Pharmacotherapy of attention-deficit/hyperactivity disorder reduces risk for substance use disorder. Pediatrics [serial online]. August 1999; 104(2):e20. Available at: http://www.pediatrics.org/cgi/content/full/104/2/e20. Accessed May 14, 2002. 2. Wilens TE, Faraone SV, Biederman J, Gunawardene S. Does stimulate therapy of attention-deficit/hyperactivity disorder beget later substance abuse? A meta-analytic review of the literature. Pediatrics. 2003;l l l:179-185. 3. Barkley RA, Fischer M, Smallish L, Fletcher K. Does the treatment of attention-deficit/hyperactivity disorder with stimulants contribute to drug use/abuse? A 13 year prospective study. Pediatrics. 2003;l l l:97-109. *A review of a total of 6 studies, 2 with follow-up in adolescence and 4 with a follow-up in young adulthood.

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