Changes in antidepressant use by young people and suicidal behavior after FDA warnings and media coverage: quasi-experimental study

Lu, Christine Y.; Zhang, Fang; Lakoma, Matthew D.; Madden, Jeanne M.; Rusinak, Donna; Penfold, Robert B.; Simon, Gregory E.; Ahmedani, Brian K.; Clarke, Gregory N.; Hunkeler, Enid M.; Waitzfelder, Beth E.; Owen-Smith, Ashli; Raebel, Marsha A.; Rossom, Rebecca C.; Coleman, Karen J.; Copeland, Laurel A.; Soumerai, Stephen B.

doi:10.1136/bmj.g3596

Cited by 182 publications

(165 citation statements)

References 34 publications

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“…27 After the warning, antidepressant use by adolescents declined by 31%. The authors concluded that although completed suicides are rare, attempted suicides increased by about 21.7% during this same time period.…”

Section: Primary Care Management Of Depression In Children and Adolesmentioning

confidence: 99%

Primary care management of depression in children and adolescents

Haefner

2016

The Nurse Practitioner

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Depression is the most common mental health disorder in children and adolescents, and primary care is often the first point of contact for children and adolescents with depression. Depression impacts all areas of life, impairing academics and interactions with family and friends. The purpose of this article is to help NPs identify and treat children and adolescents presenting with depression in the primary care setting.

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Section: Primary Care Management Of Depression In Children and Adolesmentioning

confidence: 99%

Primary care management of depression in children and adolescents

Haefner

2016

The Nurse Practitioner

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“…Finalmente, un estudio analizó el efecto en la población de las campañas de salud pública y su cobertura en los medios de comunicación (Lu et al, 2014). Concretamente, estudiaron el efecto de las campañas de prevención del suicidio mediante medicamentos antidepresivos.…”

Section: C-contenidos Publicados En Otros Medios De Comunicaciónunclassified

Avances en investigación y buenas prácticas en comunicación y salud

Terrón¹,

Peñafiel²,

Catalán³

2017

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“…Interestingly, our interrupted times series study [4] on this topic was not identified by their search, and therefore, it was not included in their review. Our study of 10 years of health care data among 7 million people investigated if the widely publicized 2004 warnings from the FDA about possible suicidality risk with antidepressants in youth were associated with changes in antidepressant use and suicidal behaviour.…”

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confidence: 99%

Comment on ‘Measuring the impact of medicines regulatory interventions – systematic review and methodological considerations’ by Goedecke et al.

Soumerai

2018

Brit J Clinical Pharma

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We read with interest the recent systematic review of studies that examined the impact of pharmacovigilance regulatory interventions worldwide by Goedecke et al.[1] and aimed to highlight methodological challenges.We agree that policies such as pharmacovigilance regulatory actions can have intended and unintended consequences. Monitoring the outcomes of such policies is an important [2] public health issue because they often affect tens of millions of people. However, we were surprised that Goedecke et al. included studies using weak research designs (for example, cross-sectional studies) that are typically excluded by international standards, i.e., Cochrane Systematic Reviews [3]. Secondly, their search and review omitted one of the most important studies in the field, our paper [4] published by BMJ in 2014 reporting an interrupted time series analysis of changes in antidepressant use and suicidal behaviour after safety FDA warnings from the US Food and Drug Administration (FDA) and media coverage.Weak research designs include single observations before and after (pre-post) an intervention without any controls and simple cross-sectional designs that correlate the exposure to an intervention with outcomes at a single point in time [5]. These designs are excluded by Cochrane systematic reviews of effects of health policies or programmes [6]. They rarely provide trustworthy evidence of policy effects because they do not control for common biases (e.g., secular trends or history bias and selection bias). Instead, interrupted time series (ITS) with and without a control series are one of the strongest quasi-experimental designs for evaluating policy effects. Based on Cochrane review standards, of the 153 articles included by Goedecke et al., only 48 ITS studies can provide credible evidence.Goedecke et al. included 27 articles that examined regulatory actions related to antidepressants. Interestingly, our interrupted times series study [4] on this topic was not identified by their search, and therefore, it was not included in their review. Our study of 10 years of health care data among 7 million people investigated if the widely publicized 2004 warnings from the FDA about possible suicidality risk with antidepressants in youth were associated with changes in antidepressant use and suicidal behaviour. We found that safety warnings and widespread media coverage decreased antidepressant use, and there were simultaneous increases in suicide attempts (as measured by psychotropic drug poisonings) among youth, which might be one consequence of under-treatment of mood disorders.Importantly, drug safety warnings or regulatory actions generally have little or no effect on health behaviour except those widely reported by media [3]. For instance, the antidepressant warnings were widely publicized by media reports [7]. It is possible that the warnings and extensive media attention led to unexpected and unintended population-level reductions in treatment for depression and subsequent increases in suicide attempts among young peo...

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Changes in antidepressant use by young people and suicidal behavior after FDA warnings and media coverage: quasi-experimental study

Cited by 182 publications

References 34 publications

Primary care management of depression in children and adolescents

Primary care management of depression in children and adolescents

Avances en investigación y buenas prácticas en comunicación y salud

Comment on ‘Measuring the impact of medicines regulatory interventions – systematic review and methodological considerations’ by Goedecke et al.

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