Reply to Antidepressant Use and Risk for Suicide Attempts in Bipolar Disorder

See original letter by Goldberg and related article by Leon, et al.

Dr Leon and Colleagues Reply

To the Editor: We thank Dr Goldberg for his comments on our article.1 The question of differential effects of antidepressants in unipolar and bipolar patients extends beyond the scope of the article. We intend to pursue this extensive set of analyses (diagnosis-specific propensity models and propensity-based matched safety models) in our future work.

The purpose of our article was to examine the risk of suicidal behavior with antidepressants in a more generalizable sample than was included in the FDA meta-analyses that served as the empirical basis for the boxed warning for antidepressants. We hypothesized, on the basis of the FDA warning, that we would find an elevated risk of suicide attempts and suicide deaths when patients received an antidepressant. Instead, we found a protective effect of antidepressants. We chose not to distinguish among diagnostic groups in our analyses because the FDA warning is not diagnosis specific: "[P]atients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior."2

References

1. Leon AC, Solomon DA, Li C, et al. Antidepressants and risks of suicide and suicide attempts: a 27-year observational study. J Clin Psychiatry. 2011;72(5):580-586. PubMed doi:10.4088/JCP.10m06552

2. United States Food and Drug Administration. Antidepressant use in children, adolescents, and young adults. Revisions to product labeling. http://www.fda.gov/downloads/Drugs/DrugSafety/InformationbyDrugClass/UCM173233.pdf. Accessed October 7, 2011.

Andrew C. Leon, PhD

acleon@med.cornell.edu

David A. Solomon, MD

Chunshan Li, MA

Jess G. Fiedorowicz, MD

William Coryell, MD

Jean Endicott, PhD

Author affiliations: Department of Psychiatry (Dr Leon and Mr Li) and Department of Public Health (Dr Leon), Weill Cornell Medical College, New York, New York; Department of Psychiatry and Human Behavior, The Warren Alpert Medical School of Brown University, Providence, Rhode Island, and UpToDate Inc, Waltham, Massachusetts (Dr Solomon); Roy J. and Lucille A. Carver College of Medicine, University of Iowa, University of Iowa Hospitals and Clinics, Iowa City (Drs Fiedorowicz and Coryell); and New York State Psychiatric Institute, New York (Dr Endicott). Potential conflicts of interest: Dr Leon has been a member of the Psychopharmacologic Drugs Advisory Committee of the US Food and Drug Administration (FDA) that examined antidepressants and suicidality; has received research support from the National Institute of Mental Health (NIMH); serves on independent data and safety monitoring boards for AstraZeneca, Pfizer, and Sunovion; has been a consultant to the FDA, NIMH, MedAvante, and Roche; and has equity in MedAvante. Dr Solomon is employed by UpToDate, Inc. Dr Endicott has received research support from NIMH and Cyberonics and has been a consultant to or advisory board member for AstraZeneca, Bayer Schering, Cyberonics, Forest, GlaxoSmithKline, Eli Lilly, Otsuka, and Wyeth-Ayerst. Mr Li and Drs Fiedorowicz and Coryell report no financial relationships with commercial interests. Funding/support: The research discussed in this letter was supported by grants from the National Institute of Mental Health. See original publication [J Clin Psychiatry 2011;72(5):580-586] for detailed information.

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