Literature DB >> 17606833

Effect of regulatory warnings on antidepressant prescribing for children and adolescents.

Benji T Kurian1, Wayne A Ray, Patrick G Arbogast, D Catherine Fuchs, Judith A Dudley, William O Cooper.   

Abstract

OBJECTIVE: To evaluate the effect of UK and US warnings placed in response to reports of suicidal thinking in pediatric patients receiving selective serotonin reuptake inhibitor and selective norepinephrine reuptake inhibitor antidepressants on antidepressant prescribing for children and adolescents.
DESIGN: Interrupted time-series analysis of antidepressant prescriptions.
SETTING: Tennessee's Medicaid program, January 1, 2002, through September 30, 2005. PARTICIPANTS: A mean of 405,000 children and adolescents aged 2 to 17 years qualified each month. Main Exposure Piecewise linear regression models were used to estimate the cumulative effect of the warnings, which were considered the exposure of interest. MAIN OUTCOME MEASURES: Monthly proportions of study children and adolescents who were new users of antidepressants, had discontinuity in antidepressant use, or were users of other psychotropic drugs.
RESULTS: During the 2 years preceding the UK warning, there was no trend in the monthly proportions of new antidepressant users, with 23 new users per 10 000 persons per month. This proportion subsequently decreased 33% (95% confidence interval, 23% to 41%; P < .001) by 21 months following the UK warning. The reduction was most pronounced for the nonfluoxetine selective serotonin reuptake inhibitors and selective norepinephrine reuptake inhibitors, where initiations decreased 54% (95% confidence interval, 46% to 62%; P < .001). In contrast, new users of fluoxetine increased 60% (95% confidence interval, 9% to 135%; P = .02). There was no increase in discontinuations of antidepressants, and there was no evidence of substitution of other psychotropic drugs.
CONCLUSION: The regulatory warnings led to decreased use of antidepressants in children and adolescents, but the clinical and public health consequences of this change are unknown.

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Year:  2007        PMID: 17606833     DOI: 10.1001/archpedi.161.7.690

Source DB:  PubMed          Journal:  Arch Pediatr Adolesc Med        ISSN: 1072-4710


  20 in total

Review 1.  Impact of safety-related regulatory action on clinical practice: a systematic review.

Authors:  Sigrid Piening; Flora M Haaijer-Ruskamp; Jonie T N de Vries; Menno E van der Elst; Pieter A de Graeff; Sabine M J M Straus; Peter G M Mol
Journal:  Drug Saf       Date:  2012-05-01       Impact factor: 5.606

2.  Effectiveness of safety warnings in atypical antipsychotic drugs: an interrupted time-series analysis in Spain.

Authors:  Gabriel Sanfélix-Gimeno; Pedro Cervera-Casino; Salvador Peiró; Beatriz González López-Valcarcel; Amparo Blázquez; Teresa Barbera
Journal:  Drug Saf       Date:  2009       Impact factor: 5.606

Review 3.  Impact of FDA drug risk communications on health care utilization and health behaviors: a systematic review.

Authors:  Stacie B Dusetzina; Ashley S Higashi; E Ray Dorsey; Rena Conti; Haiden A Huskamp; Shu Zhu; Craig F Garfield; G Caleb Alexander
Journal:  Med Care       Date:  2012-06       Impact factor: 2.983

4.  Effects of safety warnings on prescription rates of cough and cold medicines in children below 2 years of age.

Authors:  E Fatma Sen; Katia M C Verhamme; Mariagrazia Felisi; Geert W 't Jong; Carlo Giaquinto; Gino Picelli; Adriana Ceci; Miriam C J M Sturkenboom
Journal:  Br J Clin Pharmacol       Date:  2011-06       Impact factor: 4.335

5.  Impact of a National Guideline on Antibiotic Selection for Hospitalized Pneumonia.

Authors:  Derek J Williams; Matthew Hall; Jeffrey S Gerber; Mark I Neuman; Adam L Hersh; Thomas V Brogan; Kavita Parikh; Sanjay Mahant; Anne J Blaschke; Samir S Shah; Carlos G Grijalva
Journal:  Pediatrics       Date:  2017-03-08       Impact factor: 7.124

6.  Antibiotic Choice for Children Hospitalized With Pneumonia and Adherence to National Guidelines.

Authors:  Derek J Williams; Kathryn M Edwards; Wesley H Self; Yuwei Zhu; Krow Ampofo; Andrew T Pavia; Adam L Hersh; Sandra R Arnold; Jonathan A McCullers; Lauri A Hicks; Anna M Bramley; Seema Jain; Carlos G Grijalva
Journal:  Pediatrics       Date:  2015-07       Impact factor: 7.124

7.  The pharmacoepidemiology of selective serotonin reuptake inhibitors for children and adolescents in Canada from 2005 to 2009: a database analysis.

Authors:  Darren Lam; Daniel A Gorman; Scott Patten; Tamara Pringsheim
Journal:  Paediatr Drugs       Date:  2013-08       Impact factor: 3.022

8.  Dosing of Selective Serotonin Reuptake Inhibitors Among Children and Adults Before and After the FDA Black-Box Warning.

Authors:  Greta A Bushnell; Til Stürmer; Sonja A Swanson; Alice White; Deborah Azrael; Virginia Pate; Matthew Miller
Journal:  Psychiatr Serv       Date:  2015-11-16       Impact factor: 3.084

9.  The FDA And ABCs: Unintended Consequences Of Antidepressant Warnings On Human Capital.

Authors:  Susan H Busch; Ezra Golberstein; Ellen Meara
Journal:  J Hum Resour       Date:  2014

10.  The SQUIRE (Standards for QUality Improvement Reporting Excellence) guidelines for quality improvement reporting: explanation and elaboration.

Authors:  G Ogrinc; S E Mooney; C Estrada; T Foster; D Goldmann; L W Hall; M M Huizinga; S K Liu; P Mills; J Neily; W Nelson; P J Pronovost; L Provost; L V Rubenstein; T Speroff; M Splaine; R Thomson; A M Tomolo; B Watts
Journal:  Qual Saf Health Care       Date:  2008-10
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