Changes in antidepressant use by young people and suicidal behavior after FDA warnings and media coverage: quasi-experimental studyBMJ 2014; 348 doi: https://doi.org/10.1136/bmj.g3596 (Published 18 June 2014) Cite this as: BMJ 2014;348:g3596
- Christine Y Lu, instructor1,
- Fang Zhang, assistant professor1,
- Matthew D Lakoma, analyst1,
- Jeanne M Madden, instructor1,
- Donna Rusinak, program manager1,
- Robert B Penfold, assistant investigator; affiliate assistant professor23,
- Gregory Simon, senior invstigator; lead investigator24,
- Brian K Ahmedani, assistant research scientist5,
- Gregory Clarke, senior investigator6,
- Enid M Hunkeler, senior research scientist7,
- Beth Waitzfelder, investigator8,
- Ashli Owen-Smith, assistant investigator9,
- Marsha A Raebel, senior investigator10,
- Rebecca Rossom, geriatric psychiatrist11,
- Karen J Coleman, research scientist12,
- Laurel A Copeland, associate director13,
- Stephen B Soumerai, professor1
- 1Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, USA
- 2Group Health Research Institute, Seattle, WA, USA
- 3Department of Health Services Research, University of Washington, Seattle, WA, USA
- 4Mental Health Research Network
- 5Center for Health Policy and Health Services Research, Henry Ford Health System, Detroit, MI, USA
- 6Kaiser Permanente Center for Health Research, Portland, OR, USA
- 7The Division of Research, Kaiser Permanente Medical Care Program Northern California, Oakland, CA, USA
- 8Kaiser Permanente Center for Health Research Hawaii, Honolulu, HI, USA
- 9The Center for Health Research Southeast, Kaiser Permanente Georgia, Atlanta, GA, USA
- 10Kaiser Permanente Colorado Institute for Health Research, Denver, CO, USA
- 11HealthPartners Institute for Education and Research, Bloomington, MN, USA
- 12Kaiser Permanente Southern California, Department of Research and Evaluation, Pasadena, CA, USA
- 13Center for Applied Health Research, Central Texas Veterans Health Care System jointly with Scott & White Healthcare, Temple, TX, USA
- Correspondence to: C Y Lu 133 Brookline Avenue, 6th Floor, Boston, MA 02215, USA
- Accepted 21 May 2014
Objective To 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.
Design Quasi-experimental study assessing changes in outcomes after the warnings, controlling for pre-existing trends.
Setting Automated healthcare claims data (2000-10) derived from the virtual data warehouse of 11 health plans in the US Mental Health Research Network.
Participants Study cohorts included adolescents (around 1.1 million), young adults (around 1.4 million), and adults (around 5 million).
Main outcome measures Rates of antidepressant dispensings, psychotropic drug poisonings (a validated proxy for suicide attempts), and completed suicides.
Results Trends 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.
Conclusions Safety 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.
We thank all project managers and analysts in participating sites.
Contributors: SBS, RBP, CYL, FZ, and GS made substantial contributions to the study conception and design. CYL, SBS, MDL, and DR were responsible for data acquisition. CYL, SBS, MDL, FZ, and JMM were responsible for analysis of data. All authors contributed to interpretation of data. CYL drafted the article and is guarantor. All authors provided critical revisions for important intellectual content and approved the final version.
Funding: This research was supported by a cooperative agreement (U19MH092201; principal investigator, GS) with the US National Institute of Mental Health; SBS was the study principal investigator. The content is solely the responsibility of the authors and does not necessarily represent the official views of the US National Institutes of Health. The sponsor had no role in the design and conduct of the study; analysis, and interpretation of the data; the preparation of the manuscript; and the decision to submit the manuscript for publication. SBS was supported in part by the Health Delivery Systems Center for Diabetes Translational Research (HDS-CDTR) (NIDDK grant 1P30-DK092924).
Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare that all authors have support from the National Institute of Mental Health for the submitted work. FZ received personal fees from Policy Analysis outside the submitted work. RBP received research funding from Bristol-Meyers Squibb for a study regarding antipsychotic augmentation therapy for major depression in adults only. GS reports grants from Bristol-Myers Squibb outside this work. EH has two pending patents, “Individualized health care management system” (patent application No 11/155 967 publication No US20050283385. Enid Hunkeler, et al. The Permanente Medical Group will own the patent if granted), and “System and method for assisting a care partner in monitoring a patient with chronic disease” (patent application No 11/155 821 publication No US20050283384. Enid Hunkeler, et al. The Permanente Medical Group will own the patent if granted). Other authors declared no financial relationships with any organizations that might have an interest in the submitted work in the previous three years, no other relationships or activities that could appear to have influenced the submitted work.
Ethical approval: This study was approved by the institutional review boards at all participating sites as well as from state departments of public health when required for the use of information from death certificates.
Data sharing: No additional data available. Data were obtained under data users agreements with individual study sites and are not available for sharing.
Transparency: CYL affirms that the manuscript is an honest, accurate, and transparent account of the study being reported; that no important aspects of the study have been omitted; and that any discrepancies from the study as planned (and, if relevant, registered) have been explained.
This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 3.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/3.0/.