Off-label antidepressant use in children and adolescents compared with young adults: Extent and level of evidence

Pharmacoepidemiology and Drug Safety

Volumn 21, Issue 9, 2012, Pages 997-1004

  Czaja, Angela S ^a,b   Valuck, Robert ^b  

^a Children's Hospital Colorado   (United States)

^b UNIVERSITY OF COLORADO   (United States)

Author keywords

Antidepressants; Off label; Pediatrics; Pharmacoepidemiology

Indexed keywords

AMFEBUTAMONE; ANTIDEPRESSANT AGENT; ESCITALOPRAM; FLUOXETINE; IMIPRAMINE; SERTRALINE;

ADOLESCENT; ADULT; ANXIETY DISORDER; ARTICLE; ATTENTION DEFICIT DISORDER; AUTISM; CHILD; COHORT ANALYSIS; DEPRESSION; DRUG EFFICACY; HEADACHE; HUMAN; INCONTINENCE; MAJOR CLINICAL STUDY; MOOD DISORDER; OBSESSIVE COMPULSIVE DISORDER; OFF LABEL DRUG USE; PRESCHOOL CHILD; PRESCRIPTION; PRIORITY JOURNAL; PSYCHIATRIST; RETROSPECTIVE STUDY; SCHOOL CHILD;

ADOLESCENT; AGE FACTORS; ANTIDEPRESSIVE AGENTS; CHILD; CHILD, PRESCHOOL; COHORT STUDIES; DRUG APPROVAL; FEMALE; HUMANS; LONGITUDINAL STUDIES; MALE; MANAGED CARE PROGRAMS; OFF-LABEL USE; PHYSICIAN'S PRACTICE PATTERNS; RETROSPECTIVE STUDIES; TIME FACTORS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION; YOUNG ADULT;

EID: 84865864203     PISSN: 10538569     EISSN: 10991557     Source Type: Journal    
DOI: 10.1002/pds.3312     Document Type: Article

References (45)

1. Lal R, Kremzner M. Introduction to the new prescription drug labeling by the Food and Drug Administration. Am J Health Syst Pharm 2007; 64: 2488-2494.
2. Cuzzolin L, Zaccaron A, Fanos V. Unlicensed and off-label uses of drugs in paediatrics: a review of the literature. Fundam Clin Pharmacol 2003; 17: 125-131.
3. Murray ML, de Vries CS, Wong IC. A drug utilisation study of antidepressants in children and adolescents using the General Practice Research Database. Arch Dis Child 2004; 89: 1098-1102.
4. Olfson M, Gameroff MJ, Marcus SC, Waslick BD. Outpatient treatment of child and adolescent depression in the United States. Arch Gen Psychiatry 2003; 60: 1236-1242.
5. Olfson M, Marcus SC. National patterns in antidepressant medication treatment. Arch Gen Psychiatry 2009; 66: 848-856.
6. Vitiello B, Zuvekas SH, Norquist GS. National estimates of antidepressant medication use among U.S. children, 1997-2002. J Am Acad Child Adolesc Psychiatry 2006; 45: 271-279.
7. Friedman RA, Leon AC. Expanding the black box-depression, antidepressants, and the risk of suicide. N Engl J Med 2007; 356: 2343-2346.
8. Simon GE. The antidepressant quandary-considering suicide risk when treating adolescent depression. N Engl J Med 2006; 355: 2722-2723.
9. Mann JJ, Emslie G, Baldessarini RJ, et al. ACNP Task Force report on SSRIs and suicidal behavior in youth. Neuropsychopharmacology 2006; 31: 473-492.
10. Lee E, Teschemaker AR, Johann-Liang R, et al. Off-label prescribing patterns of antidepressants in children and adolescents. Pharmacoepidemiol Drug Saf 2011; 21(2): 137-144.
11. Czaja AS, Zimmerman JJ, Nathens AB. Readmission and late mortality after pediatric severe sepsis. Pediatrics 2009; 123: 849-857.
12. Malone DC, Billups SJ, Valuck RJ, Carter BL. Development of a chronic disease indicator score using a Veterans Affairs Medical Center medication database. IMPROVE Investigators. J Clin Epidemiol 1999; 52: 551-557.
13. Drugs@FDA: FDA approved drug products. (Accessed November 2010, at http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm.)
14. Hiemke C, Hartter S. Pharmacokinetics of selective serotonin reuptake inhibitors. Pharmacol Ther 2000; 85: 11-28.
15. Smith EG. Association between antidepressant half-life and the risk of suicidal ideation or behavior among children and adolescents: confirmatory analysis and research implications. J Affect Disord 2009; 114: 143-148.
16. Chen DT, Wynia MK, Moloney RM, Alexander GC. U.S. physician knowledge of the FDA-approved indications and evidence base for commonly prescribed drugs: results of a national survey. Pharmacoepidemiol Drug Saf 2009; 18: 1094-1100.
17. Emslie GJ, Mayes T, Porta G, et al. Treatment of Resistant Depression in Adolescents (TORDIA): week 24 outcomes. Am J Psychiatry 2010; 167: 782-791.
18. Zito JM, Derivan AT, Kratochvil CJ, Safer DJ, Fegert JM, Greenhill LL. Off-label psychopharmacologic prescribing for children: history supports close clinical monitoring. Child Adolesc Psychiatry Ment Health 2008; 2: 24.
19. Kearns GL, Abdel-Rahman SM, Alander SW, Blowey DL, Leeder JS, Kauffman RE. Developmental pharmacology-drug disposition, action, and therapy in infants and children. N Engl J Med 2003; 349: 1157-1167.
20. Bylund DB, Reed AL. Childhood and adolescent depression: why do children and adults respond differently to antidepressant drugs? Neurochem Int 2007; 51: 246-253.
21. Kaufman J, Martin A, King RA, Charney D. Are child-, adolescent-, and adult-onset depression one and the same disorder? Biol Psychiatry 2001; 49: 980-1001.
22. Hazell P, O'Connell D, Heathcote D, Henry D. Tricyclic drugs for depression in children and adolescents. Cochrane Database Syst Rev 2002; 2: CD002317.
23. Hazell P, O'Connell D, Heathcote D, Robertson J, Henry D. Efficacy of tricyclic drugs in treating child and adolescent depression: a meta-analysis. BMJ 1995; 310: 897-901.
24. Safer DJ, Zito JM. Treatment-emergent adverse events from selective serotonin reuptake inhibitors by age group: children versus adolescents. J Child Adolesc Psychopharmacol 2006; 16: 159-169.
25. Barbui C, Esposito E, Cipriani A. Selective serotonin reuptake inhibitors and risk of suicide: a systematic review of observational studies. CMAJ 2009; 180: 291-297.
26. Fugh-Berman A, Melnick D. Off-label promotion, on-target sales. PLoS Med 2008; 5: e210.
27. Kesselheim AS, Mello MM, Studdert DM. Strategies and practices in off-label marketing of pharmaceuticals: a retrospective analysis of whistleblower complaints. PLoS Med 2011; 8: e1000431.
28. Lexchin J. Interactions between physicians and the pharmaceutical industry: what does the literature say? CMAJ 1993; 149: 1401-1407.
29. Wazana A. Gifts to physicians from the pharmaceutical industry. JAMA 2000; 283: 2655-2658.
30. Wazana A. Physicians and the pharmaceutical industry: is a gift ever just a gift? JAMA 2000; 283: 373-380.
31. Committee on Drugs, American Academy of Pediatrics. Uses of drugs not described in the package insert (off-label uses). Pediatrics 2002; 110: 181-183.
32. Walton SM, Schumock GT, Lee KV, Alexander GC, Meltzer D, Stafford RS. Prioritizing future research on off-label prescribing: results of a quantitative evaluation. Pharmacotherapy 2008; 28: 1443-1452.
33. Busch SH, Leslie D, Rosenheck R. Measuring quality of pharmacotherapy for depression in a national health care system. Med Care 2004; 42: 532-542.
34. Druss BG, Miller CL, Rosenheck RA, Shih SC, Bost JE. Mental health care quality under managed care in the United States: a view from the Health Employer Data and Information Set (HEDIS). Am J Psychiatry 2002; 159: 860-862.
35. Kobak KA, Taylor L, Katzelnick DJ, Olson N, Clagnaz P, Henk HJ. Antidepressant medication management and Health Plan Employer Data Information Set (HEDIS) criteria: reasons for nonadherence. J Clin Psychiatry 2002; 63: 727-732.
36. Morrato EH, Libby AM, Orton HD, et al. Frequency of provider contact after FDA advisory on risk of pediatric suicidality with SSRIs. Am J Psychiatry 2008; 165: 42-50.
37. Robinson RL, Long SR, Chang S, et al. Higher costs and therapeutic factors associated with adherence to NCQA HEDIS antidepressant medication management measures: analysis of administrative claims. J Manag Care Pharm 2006; 12: 43-54.
38. Rost K, Dickinson LM, Fortney J, Westfall J, Hermann RC. Clinical improvement associated with conformance to HEDIS-based depression care. Ment Health Serv Res 2005; 7: 103-112.
39. Scholle SH. NCQA behavioral health measurement efforts. J Manag Care Pharm 2005; 11: S9-11.
40. Heflinger CA, Hinshaw SP. Stigma in child and adolescent mental health services research: understanding professional and institutional stigmatization of youth with mental health problems and their families. Adm Policy Ment Health 2010; 37: 61-70.
41. Lish JD, Kuzma MA, Lush DT, Plescia G, Farber NJ, Zimmerman M. Psychiatric screening in primary care: what do patients really want? J Psychosom Res 1997; 42: 167-175.
42. Main DS, Lutz LJ, Barrett JE, Matthew J, Miller RS. The role of primary care clinician attitudes, beliefs, and training in the diagnosis and treatment of depression. A report from the Ambulatory Sentinel Practice Network Inc. Arch Fam Med 1993; 2: 1061-1066.
43. Orleans CT, George LK, Houpt JL, Brodie HK. How primary care physicians treat psychiatric disorders: a national survey of family practitioners. Am J Psychiatry 1985; 142: 52-57.
44. Alexander GC, Gallagher SA, Mascola A, Moloney RM, Stafford RS. Increasing off-label use of antipsychotic medications in the United States, 1995-2008. Pharmacoepidemiol Drug Saf 2011; 20: 177-184.
45. Radley DC, Finkelstein SN, Stafford RS. Off-label prescribing among office-based physicians. Arch Intern Med 2006; 166: 1021-1026.