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Epstein R, Fonnesbeck C, Williamson E, et al. Psychosocial and Pharmacologic Interventions for Disruptive Behavior in Children and Adolescents [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2015 Oct. (Comparative Effectiveness Reviews, No. 154.)
Psychosocial and Pharmacologic Interventions for Disruptive Behavior in Children and Adolescents [Internet].
Show detailsThe harms data provided in this section were gathered from analyzing available gray literature (i.e. package inserts and FDA review packages). FDA approval packages were limited to those available on the FDA website that contained a “Medical Review” section of the document. Upon further analysis, approval packages that did not assess pediatric safety data were not included. Table I-1 includes the pediatric indication for medications referenced in the clinical studies included in this review. Medications that have not been approved as safe and effective in pediatric patients; therefore are only FDA approved in adults are referenced in Table I-2. Notable boxed warnings, contraindications, and warnings/precautions that would be relevant to consider in the pediatric population were included. As a result, the data provided in this chart is not an all-inclusive list of these package insert sections. For complete data please see the corresponding package insert.
Updated: September 28, 2014
Table I-1. FDA-approved pediatric medications included in literature review
Table I-3. Serious adverse events reported across medications
Table I-4. Selected adverse events observed across medications
Table I-5. Pharmacologic agents considered for DBD review
Table I-6. FDA approval status for drugs included in the DBD review
References for Appendix I
- 1.
- Intuniv [package insert]. Wayne, PA: Shire US Inc.; 2013.
- 2.
- Depakote [package insert]. North Chicago, IL: AbbVie Inc.; Jul, 2013.
- 3.
- Abilify [package insert]. Rockville, MD: Otsuka America Pharmaceutical, Inc.; 2013.
- 4.
- Strattera [package insert]. Indianapolis, IN: Eli Lilly and Company; 2014.
- 5.
- Adderall [package insert]. Pomona, NY: Barr Laboratories; 2007.
- 6.
- Ritalin [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2013.
- 7.
- Seroquel [package inert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; Oct, 2013.
- 8.
- Risperdal [package insert]. Titusville, NJ: Janssen Pharmaceuticals, Inc.; 2014.
- 9.
- Geodon [package insert]. New York, NY: Pfizer; Oct, 2012.
- 10.
- Abilify Medical Review - Schizophrenia in Pediatric Patients. Silver Spring, MD: Food and Drug Administration Center for Drug Evaluation and Research; 2007.
- 11.
- Strattera Medical Review - Original Approval. Silver Spring, MD: Food and Drug Administration Center for Drug Evaluation and Research; 2002.
- 12.
- Intuniv Medical Review - Original Approval. Silver Spring, MD: Food and Drug Administration Center for Drug Evaluation and Research; 2009.
- 13.
- Seroquel Medical Review - QT Prolongation Review. Silver Spring, MD: Food and Drug Administration Center for Drug Evaluation and Research; 2011.
- 14.
- Risperdal Medical Review - Pediatric Approval. Silver Spring, MD: Food and Drug Administration Center for Drug Evaluation and Research; 2007.
- Pharmacologic Approval Status, Harms, and Indications - Psychosocial and Pharmac...Pharmacologic Approval Status, Harms, and Indications - Psychosocial and Pharmacologic Interventions for Disruptive Behavior in Children and Adolescents
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