Dataset Information

A 10-year analysis of the effects of media coverage of regulatory warnings on antidepressant use in The Netherlands and UK.

ABSTRACT:

Background

In 2003-2004 and 2007-2008, the regulatory banning of SSRI use in pediatrics and young adults due to concerns regarding suicidality risk coincided with negative media coverage. SSRI use trends were analyzed from 2000-2010 in the Netherlands (NL) and the UK, and whether trend changes might be associated with media coverage of regulatory warnings.

Methods

Monthly SSRIs sales were presented as DDDs/1000 inhabitants/day. SSRI-use trends were studied using time-series segmented regression analyses. Timing of trend changes was compared with two periods of media coverage of warnings. Annual Dutch SSRI prescription data were analyzed by age group.

Results

Trend changes in SSRI use largely corroborated with the periods of media coverage of warnings. British SSRI use declined from 3.9 to 0.7 DDDs/month (95%CI 3.3;4.5 & 0.5;0.9, respectively) before the first warning period (2003-2004). A small decrease of -0.6 DDDs/month (-1.2; -0.05) was observed in Dutch SSRI use shortly after 2003-2004. From 2007-2008, British SSRI use stabilized, whilst Dutch SSRI use diminished to -0.04 DDDs/month (-0.4;0.3). Stratified analyses showed a rapid decrease of -1.2 DDDs/month (-2.1; -1.7) in UK paroxetine use before 2003-2004, but only a minimal change in Dutch paroxetine use (-0.3 DDDs/month -0.8;0.2). Other SSRI use, especially (es)citalopram, increased during 2003-2004 in both countries. Significant reductions in Dutch paroxetine use were observed in pediatrics, adolescents, and young adults after 2003-2004.

Conclusion

Changes in SSRI use (NL & UK) were associated with the timing of the combined effect of media coverage and regulatory warnings. Our long-term assessment illustrates that changes in SSRI use were temporal, drug-specific and more pronounced in pediatrics and young adults. The twofold increase in SSRI use over one decade indicates that regulatory warnings and media coverage may come and go, but they do not have a significant impact on the overall upward trend of SSRI use as a class in both countries.

SUBMITTER: Hernandez JF

PROVIDER: S-EPMC3447767 | biostudies-literature | 2012

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

A 10-year analysis of the effects of media coverage of regulatory warnings on antidepressant use in The Netherlands and UK.

Hernandez Juan Francisco JF Mantel-Teeuwisse Aukje K AK van Thiel Ghislaine J M W GJ Belitser Svetlana V SV Warmerdam Jan J de Valk Vincent V Raaijmakers Jan A M JA Pieters Toine T

PloS one 20120920 9

<h4>Background</h4>In 2003-2004 and 2007-2008, the regulatory banning of SSRI use in pediatrics and young adults due to concerns regarding suicidality risk coincided with negative media coverage. SSRI use trends were analyzed from 2000-2010 in the Netherlands (NL) and the UK, and whether trend changes might be associated with media coverage of regulatory warnings.<h4>Methods</h4>Monthly SSRIs sales were presented as DDDs/1000 inhabitants/day. SSRI-use trends were studied using time-series segmen ...[more]

PMID: 23029065

Similar Datasets

Project description:ObjectiveTo investigate if the widely publicized warnings in 2003 from the US Food and Drug Administration about a possible increased risk of suicidality with antidepressant use in young people were associated with changes in antidepressant use, suicide attempts, and completed suicides among young people.DesignQuasi-experimental study assessing changes in outcomes after the warnings, controlling for pre-existing trends.SettingAutomated healthcare claims data (2000-10) derived from the virtual data warehouse of 11 health plans in the US Mental Health Research Network.ParticipantsStudy cohorts included adolescents (around 1.1 million), young adults (around 1.4 million), and adults (around 5 million).Main outcome measuresRates of antidepressant dispensings, psychotropic drug poisonings (a validated proxy for suicide attempts), and completed suicides.ResultsTrends in antidepressant use and poisonings changed abruptly after the warnings. In the second year after the warnings, relative changes in antidepressant use were -31.0% (95% confidence interval -33.0% to -29.0%) among adolescents, -24.3% (-25.4% to -23.2%) among young adults, and -14.5% (-16.0% to -12.9%) among adults. These reflected absolute reductions of 696, 1216, and 1621 dispensings per 100,000 people among adolescents, young adults, and adults, respectively. Simultaneously, there were significant, relative increases in psychotropic drug poisonings in adolescents (21.7%, 95% confidence interval 4.9% to 38.5%) and young adults (33.7%, 26.9% to 40.4%) but not among adults (5.2%, -6.5% to 16.9%). These reflected absolute increases of 2 and 4 poisonings per 100,000 people among adolescents and young adults, respectively (approximately 77 additional poisonings in our cohort of 2.5 million young people). Completed suicides did not change for any age group.ConclusionsSafety warnings about antidepressants and widespread media coverage decreased antidepressant use, and there were simultaneous increases in suicide attempts among young people. It is essential to monitor and reduce possible unintended consequences of FDA warnings and media reporting.

Project description:BackgroundSocial media has become a new source for obtaining real-world data on adverse drug reactions. Many studies have investigated the use of social media to detect early signals of adverse drug reactions. However, the trustworthiness of signals derived from social media is questionable. To confirm this, a confirmatory study with a positive control (eg, new black box warnings, labeling changes, or withdrawals) is required.ObjectiveThis study aimed to evaluate the use of social media in detecting new black box warnings, labeling changes, or withdrawals in advance.MethodsThis scoping review adhered to the Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews checklist. A researcher searched PubMed and EMBASE in January 2021. Original studies analyzing black box warnings, labeling changes, or withdrawals from social media were selected, and the results of the studies were summarized.ResultsA total of 14 studies were included in this scoping review. Most studies (8/14, 57.1%%) collected data from a single source, and 10 (71.4%) used specialized health care social networks and forums. The analytical methods used in these studies varied considerably. Three studies (21.4%) manually annotated posts, while 5 (35.7%) adopted machine learning algorithms. Nine studies (64.2%) concluded that social media could detect signals 3 months to 9 years before action from regulatory authorities. Most of these studies (8/9, 88.9%) were conducted on specialized health care social networks and forums. On the contrary, 5 (35.7%) studies yielded modest or negative results. Of these, 2 (40%) used generic social networking sites, 2 (40%) used specialized health care networks and forums, and 1 (20%) used both generic social networking sites and specialized health care social networks and forums. The most recently published study recommends not using social media for pharmacovigilance. Several challenges remain in using social media for pharmacovigilance regarding coverage, data quality, and analytic processing.ConclusionsSocial media, along with conventional pharmacovigilance measures, can be used to detect signals associated with new black box warnings, labeling changes, or withdrawals. Several challenges remain; however, social media will be useful for signal detection of frequently mentioned drugs in specialized health care social networks and forums. Further studies are required to advance natural language processing and mine real-world data on social media.

Dataset Information

A 10-year analysis of the effects of media coverage of regulatory warnings on antidepressant use in The Netherlands and UK.

Background

Methods

Results

Conclusion

Publications

A 10-year analysis of the effects of media coverage of regulatory warnings on antidepressant use in The Netherlands and UK.

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