Literature DB >> 19414881

Pediatric antidepressant use after the black-box warning.

Susan H Busch1, Colleen L Barry.   

Abstract

In 2004 the Food and Drug Administration (FDA) required a black-box warning on antidepressants that describes a possible suicide risk in children. An analysis of the events, evidence, and FDA actions reveals information asymmetries that affect various players' ability to identify and act on risks. Antidepressant use declined sharply overall, not just among children, and the FDA's emphasis on the proven efficacy of fluoxetine (generic Prozac) did not prompt dramatic shifts in prescribing. We conclude that risk communication strategies need to be refined, to ensure intended results.

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Year:  2009        PMID: 19414881      PMCID: PMC2768536          DOI: 10.1377/hlthaff.28.3.724

Source DB:  PubMed          Journal:  Health Aff (Millwood)        ISSN: 0278-2715            Impact factor:   6.301


  19 in total

1.  Coverage by the news media of the benefits and risks of medications.

Authors:  R Moynihan; L Bero; D Ross-Degnan; D Henry; K Lee; J Watkins; C Mah; S B Soumerai
Journal:  N Engl J Med       Date:  2000-06-01       Impact factor: 91.245

2.  Antidepressants and children. Buried data can be hazardous to a company's health.

Authors:  Eliot Marshall
Journal:  Science       Date:  2004-06-11       Impact factor: 47.728

3.  Antidepressants and pediatric depression--the risk of doing nothing.

Authors:  David A Brent
Journal:  N Engl J Med       Date:  2004-10-14       Impact factor: 91.245

4.  The antidepressant quandary--considering suicide risk when treating adolescent depression.

Authors:  Gregory E Simon
Journal:  N Engl J Med       Date:  2006-12-28       Impact factor: 91.245

5.  Peer-reviewed publication of clinical trials completed for pediatric exclusivity.

Authors:  Daniel K Benjamin; Philip Brian Smith; M Dianne Murphy; Rosemary Roberts; Lisa Mathis; Debbie Avant; Robert M Califf; Jennifer S Li
Journal:  JAMA       Date:  2006-09-13       Impact factor: 56.272

6.  National health spending in 2007: slower drug spending contributes to lowest rate of overall growth since 1998.

Authors:  Micah Hartman; Anne Martin; Patricia McDonnell; Aaron Catlin
Journal:  Health Aff (Millwood)       Date:  2009 Jan-Feb       Impact factor: 6.301

7.  A matter of perspective: choosing for others differs from choosing for yourself in making treatment decisions.

Authors:  Brian J Zikmund-Fisher; Brianna Sarr; Angela Fagerlin; Peter A Ubel
Journal:  J Gen Intern Med       Date:  2006-06       Impact factor: 5.128

8.  Risk factors for adolescent suicide. A comparison of adolescent suicide victims with suicidal inpatients.

Authors:  D A Brent; J A Perper; C E Goldstein; D J Kolko; M J Allan; C J Allman; J P Zelenak
Journal:  Arch Gen Psychiatry       Date:  1988-06

9.  Antidepressants and the risk of suicide, attempted suicide, and overall mortality in a nationwide cohort.

Authors:  Jari Tiihonen; Jouko Lönnqvist; Kristian Wahlbeck; Timo Klaukka; Antti Tanskanen; Jari Haukka
Journal:  Arch Gen Psychiatry       Date:  2006-12

10.  Reducing the influence of anecdotal reasoning on people's health care decisions: is a picture worth a thousand statistics?

Authors:  Angela Fagerlin; Catharine Wang; Peter A Ubel
Journal:  Med Decis Making       Date:  2005 Jul-Aug       Impact factor: 2.583

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  12 in total

1.  Who cares about a label? The effect of pediatric labeling changes on prescription drug utilization.

Authors:  Christopher Ody; Matt Schmitt
Journal:  Int J Health Econ Manag       Date:  2019-03-18

2.  Characterizing declines in pediatric antidepressant use after new risk disclosures.

Authors:  Susan H Busch; Richard G Frank; Andres Martin; Colleen L Barry
Journal:  Med Care Res Rev       Date:  2010-07-30       Impact factor: 3.929

Review 3.  Association between leukotriene-modifying agents and suicide: what is the evidence?

Authors:  Glen T Schumock; Todd A Lee; Min J Joo; Robert J Valuck; Leslie T Stayner; Robert D Gibbons
Journal:  Drug Saf       Date:  2011-07-01       Impact factor: 5.606

4.  Differences in diffusion of FDA antidepressant risk warnings across racial-ethnic groups.

Authors:  Andrea Elizabeth DePetris; Benjamin L Cook
Journal:  Psychiatr Serv       Date:  2013-05-01       Impact factor: 3.084

5.  The impact of emerging safety and effectiveness evidence on the use of physician-administered drugs: the case of bevacizumab for breast cancer.

Authors:  Rena M Conti; Stacie B Dusetzina; Ann C Herbert; Ernst R Berndt; Haiden A Huskamp; Nancy L Keating
Journal:  Med Care       Date:  2013-07       Impact factor: 2.983

6.  Antidepressant Regulatory Warnings, Prescription Patterns, Suicidality and Other Aggressive Behaviors in Major Depressive Disorder and Anxiety Disorders.

Authors:  Saurabh Gupta; Kenneth Ronald Gersing; Alaattin Erkanli; Tal Burt
Journal:  Psychiatr Q       Date:  2016-06

7.  Impact of FDA black box advisory on antipsychotic medication use.

Authors:  E Ray Dorsey; Atonu Rabbani; Sarah A Gallagher; Rena M Conti; G Caleb Alexander
Journal:  Arch Intern Med       Date:  2010-01-11

8.  Long-Run Trends in Antidepressant Use Among Youths After the FDA Black Box Warning.

Authors:  Nilay Kafali; Ana Progovac; Sherry Shu-Yeu Hou; Benjamin Lê Cook
Journal:  Psychiatr Serv       Date:  2017-12-15       Impact factor: 3.084

9.  Near Real-time Surveillance for Consequences of Health Policies Using Sequential Analysis.

Authors:  Christine Y Lu; Robert B Penfold; Sengwee Toh; Jessica L Sturtevant; Jeanne M Madden; Gregory Simon; Brian K Ahmedani; Gregory Clarke; Karen J Coleman; Laurel A Copeland; Yihe G Daida; Robert L Davis; Enid M Hunkeler; Ashli Owen-Smith; Marsha A Raebel; Rebecca Rossom; Stephen B Soumerai; Martin Kulldorff
Journal:  Med Care       Date:  2018-05       Impact factor: 2.983

10.  Psychotropic medication use in youth at high risk for psychosis: comparison of baseline data from two research cohorts 1998-2005 and 2008-2011.

Authors:  Scott W Woods; Jean Addington; Carrie E Bearden; Kristin S Cadenhead; Tyrone D Cannon; Barbara A Cornblatt; Daniel H Mathalon; Diana O Perkins; Larry J Seidman; Ming T Tsuang; Elaine F Walker; Thomas H McGlashan
Journal:  Schizophr Res       Date:  2013-06-17       Impact factor: 4.939

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