Practice Parameter for the Assessment and Treatment of Children and Adolescents With Substance Use Disorders
Abstract
This practice parameter describes the assessment and treatment of children and adolescents with substance use disorders and is based on scientific evidence and clinical consensus regarding diagnosis and effective treatment as well as on the current state of clinical practice. This parameter considers risk factors for substance use and related problems, normative use of substances by adolescents, the comorbidity of substance use disorders with other psychiatric disorders, and treatment settings and modalities.
(Reprinted with permission from the Journal of the American Academy of Child and Adolescent Psychiatry 2005; 44(6):609–621)
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Note from the FOCUS Editors:
This guideline references drugs for which important revised regulatory information has been released. See FDA Website: www.fda.gov/default.htm
Atomoxetine (Strattera)
September/29/2005 http://www.fda.gov/cder/drug/infopage/atomoxetine/default.htm
FDA Alert [9/2005]: Suicidal Thinking in Children and Adolescents
The Food and Drug Administration (FDA) directed Eli Lilly (Lilly) to revise the labeling for Strattera to include a boxed warning and additional warning statements regarding an increased risk of suicidal thinking in children and adolescents being treated with this drug. In addition, a Medication Guide will be prepared to provide directly to patients, their families, and caregivers information about the risks mentioned above. The Medication Guide is intended to be distributed by the pharmacist with each prescription or refill of a medication.
Strattera is currently approved in the United States to treat ADHD in children, adolescents, and adults.
Strattera has not been studied in children under 6 years of age.
Suicidality in Children and Adolescents Being Treated With Antidepressant Medications
October 15, 2004 http://www.fda.gov/cder/drug/antidepressants/SSRIPHA200410.htm
Today the Food and Drug Administration (FDA) directed manufacturers of all antidepressant drugs to revise the labeling for their products to include a boxed warning and expanded warning statements that alert health care providers to an increased risk of suicidality (suicidal thinking and behavior) in children and adolescents being treated with these agents, and to include additional information about the results of pediatric studies. FDA also informed these manufacturers that it has determined that a Patient Medication Guide (MedGuide), which will be given to patients receiving the drugs to advise them of the risk and precautions that can be taken, is appropriate for these drug products. These labeling changes are consistent with the recommendations made to the Agency at a joint meeting of the Psychopharmacologic Drugs Advisory Committee and the Pediatric Drugs Advisory Committee on September 13–14, 2004.
Pemoline Tablets and Chewable Tablets (Cylert)
FDA Alert [10/24/2005]: Liver Injury Risk and Market Withdrawal http://www.fda/gov/cder/drug/InfoSheets/HCP/pemolineHCP.htm
The Agency (FDA) has concluded that the overall risk of liver toxicity from Cylert and generic pemoline products outweighs the benefits of this drug. In May 2005, Abbott chose to stop sales and marketing of Cylert in the U.S. All generic companies have also agreed to stop sales and marketing of this product (Pemoline tablets and chewable tablets). Cylert is a central nervous system stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). This product is considered second line therapy for ADHD because of its association with life threatening hepatic failure (see BOXED WARNING in product label and patient package insert, available at http://www.fda.gov/cder/foi/label/2003/016832s022_017703s018lbl.pdf
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Published online: 1 April 2007
Published in print: April 2007
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