Research in Social and Administrative Pharmacy
Volume 6, Issue 1 , Pages 78-84 , March 2010

Health care consequences of black-box warnings for antidepressants in the United States and Canada

  • Saurabh Nagar, B.Pharm.

      Affiliations

    • Department of Clinical Sciences and Administration, College of Pharmacy, University of Houston, Texas Medical Center, 1441, Moursund Street, Houston, TX 77030-3407, USA
    • ,
  • Sandhya Mehta, B.Pharm.

      Affiliations

    • Department of Clinical Sciences and Administration, College of Pharmacy, University of Houston, Texas Medical Center, 1441, Moursund Street, Houston, TX 77030-3407, USA
    • ,
  • Vinod Bhatara, M.D., M.S.

      Affiliations

    • University of South Dakota Sanford School of Medicine, Sioux Falls, SD 57105
    • ,
  • Rajender Aparasu, M. Pharm., Ph.D.

      Affiliations

    • Department of Clinical Sciences and Administration, College of Pharmacy, University of Houston, Texas Medical Center, 1441, Moursund Street, Houston, TX 77030-3407, USA
    • Corresponding Author InformationCorresponding author. Tel.: +1 713 795 8374; fax: +1 713 795 8383.

References 

  1. Mark Olfson, Steven Marcus, Benjamin Druss. Effects of food and drug administration warnings on antidepressant use in a national sample. Arch Gen Psychiatry. 2008;65(1):94–101
  2. Harris G. FDA toughens warning on antidepressant drugs. Available at: New York Times. October 2004;http://www.nytimes.com/2004/10/16/politics/16depress.htmlAccessed 20.01.09
  3. Vedantam S. Depression drugs to carry warning: FDA orders notice of risks for youths. Washington Post; October 16, 2004:A01.
  4. Brent DA. Antidepressants and pediatric depression—the risk of doing nothing. N Engl J Med. 2004;351(16):1598–1601
  5. Newman TB. A black-box warning for antidepressants in children?. N Engl J Med. 2004;351(16):1595–1598
  6. FDA . FDA Public Health Advisory: Report of suicidality in pediatric patients being treated with antidepressant medications for major depressive disorder (MDD). Available at: http://www.fda.gov/CDER/drug/advisory/mdd.htmOctober 27, 2003;US Food and Drug Administration website. Accessed 17.02.09
  7. FDA . FDA Public Health Advisory: Sucidality in children and adolescents being treated with antidepressant medications. Available at: http://www.fda.gov/CDER/DRUG/antidepressants/SSRIPHA200410.htmOctober 15, 2004;US Food and Drug Administration website. Accessed 17.02.09
  8. FDA . FDA news: FDA launches a multi-prolonged strategy to strengthen safeguards for children treated with antidepressant medications. Available at: http://www.fda.gov/bbs/topics/news/2007/new01624.htmlMay 2007;US Food and Drug Administration website. Accessed 17.02.09
  9. Hetrick SE, Merry SN, McKenzie J, et al. Selective serotonin reuptake inhibitors (SSRIs) for depressive disorders in children and adolescents. Cochrane Database of Systematic Reviews. 2007;Issue 3
  10. Whittington CJ, Kendall T, Fonagy P, et al. Selective serotonin reuptake inhibitors in childhood depression: systematic review of published versus unpublished data. Lancet. 2004;363(9418):1341–1345
  11. Zito JM, Safer DJ, Dosreis S, et al. Rising prevalence of antidepressants among US youths. Pediatrics. 2002;109(5):721–727
  12. Vitello B, Zuvekas SH, Norquist GS, et al. National estimates of antidepressant medication use among U.S. children, 1997-2002. J Am Academy Child Adolesc Psychiatry. 2006;45(3):271–279
  13. Ma J, Lee KV, Stafford RS. Depression treatment during the outpatient visits by U.S. children and adolescents. J Adolesc Health. 2005;37(6):434–442
  14. Nemeroff CB, Kalali A, Keller MB, et al. Impact of publicity concerning pediatric suicidality data on physician practice patterns in the United States. Arch Gen Psychiatry. 2007;64(4):466–472
  15. Libby AM, Brent DA, Morrato EH, et al. Decline in treatment of pediatric depression after FDA advisory on risk of suicidality with SSRIs. Am J Psychiatry. 2007;164(6):884–891
  16. Valuck RJ, Libby AM, Orton HD, et al. Spillover effects on treatment of adult depression in primary care after FDA advisory on risk of pediatric suicidality with SSRIs. Am J Psychiatry. 2007;164(8):1198–1205
  17. Gibbons RD, Brown CH, Hur K, et al. Early evidence on the effects of regulator's suicidality warnings on SSRI prescriptions and suicide in children and adolescents. Am J Psychiatry. 2007;164(9):1356–1363
  18. Morrato EH, Libby AM, Orton DH, et al. Frequency of provider contact after FDA advisory on risk of pediatric suicidality with SSRIs. Am J Psychiatry. 2008;165(1):42–50
  19. Kurian BT, Ray WA, Arbogast PG, et al. Effect of regulatory warnings on antidepressant prescribing for children and adolescents. Arch Pedatr Adolesc Med. 2007;161(7):690–696
  20. Katz LY, Kozyrskyj AL, Prior HJ, et al. Effect of regulatory warnings on antidepressant prescription rates, use of healthcare services and outcomes among children, adolescent and young adults. CMAJ. 2008;178(8):1005–1011
  21. FDA . Labeling change request letter for antidepressant medications. Available at: http://www.fda.gov/CDER/DRUG/antidepressants/ssrilabelchange.htmMay 2007;US Food and Drug Administration website. Accessed 17.02.09
  22. Lineberry TW, Bostwick JM, Beebe TJ, et al. Impact of the FDA black-box warnings on physician antidepressant prescribing and practice patterns: opening pandora's suicide box. Mayo Clin Proc. 2007;82(4):516–522
  23. Mann JJ, Emslie G, Baldessarini RJ, et al. ACNP Task force report on SSRIs and suicidal behavior in youth. Neuropsychopharmacology. 2006;31(3):473–492

 Declaration of interest: The authors have no relevant financial interest to declare. No funding was received for this study.

PII: S1551-7411(09)00045-X

doi: 10.1016/j.sapharm.2009.02.005

Research in Social and Administrative Pharmacy
Volume 6, Issue 1 , Pages 78-84 , March 2010

Article Tools