ReportsAn analysis of reports of depression and suicide in patients treated with isotretinoin☆,☆☆,★,★★
Section snippets
Methods
The Office of Post-Marketing Drug Risk Assessment of the FDA receives reports of adverse drug events primarily from physicians and pharmacists who submit them on a standardized form directly to the FDA or indirectly through pharmaceutical companies. Reports are entered into a computerized database, the Adverse Event Reporting System (AERS) using a coding thesaurus of adverse reaction terms used for searching and retrieval purposes. From 1969 through September 2000, more than 2 million reports
Results
In the 18-year period from marketing of isotretinoin to May 2000, the FDA received reports of depression, suicidal ideation, suicide attempts, and completed suicide for 431 exposed patients. Data describing these patients are given in the following paragraphs.
Discussion
There are several pieces of evidence that suggest a possible causal association between depression and isotretinoin. These include the relatively large number of reports of serious depression submitted to the FDA for isotretinoin; the temporal relationship between use of the drug and the onset, or worsening, of depression; positive dechallenges with isotretinoin discontinuation and initiation of psychiatric treatment; and positive rechallenges. In addition, the relationship between use of
Acknowledgements
Several persons at the FDA have been involved over time in the analysis and interpretation of psychiatric case reports with isotretinoin exposure, including Kathryn O'Connell, MD, Jonathan Wilkin, MD, Amarilys Vega, MD, Roger Goetsch, RPh, MPH, David Graham, MD, Anne Trontell, MD, Claudia Karwoski, PharmD, and Erick Turner, MD. We acknowledge the assistance of Ana Szarfman, MD, PhD, for data mining analyses. We also thank physicians, pharmacists, patients and their families, and other reporters
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2021, Journal of Affective Disorders ReportsCitation Excerpt :The authors found 47 cases of suicide and 56 cases of suicidal ideation reported. Wysowski et al. (2001a) published reports of depression and suicide to the Food and Drug Administration (FDA) in patients treated with isotretinoin from 1982 to May 2000 that were entered in the Adverse Event Reporting System database. In that period, the FDA received 37 reports of patients treated with isotretinoin who committed suicide; 110 who were hospitalized for depression, suicidal ideation or suicide attempt; and 284 with no hospitalized depression, for a total of 431 patients.
Psychiatric disorders and suicidal behavior in patients with acne prescribed oral antibiotics versus isotretinoin: Analysis of a large commercial insurance claims database
2021, Journal of the American Academy of DermatologyCitation Excerpt :We speculate that greater severity of disease in the isotretinoin group may account for this trend, as acne severity has been correlated with an increased risk of psychiatric disturbances and social impairment.13 Case reports of a challenge-rechallenge response in some patients suggest that depression may be a rare idiosyncratic side effect of isotretinoin,23,24 although if this were the case, it is likely so rare that it did not translate to increased suicidal behavior in our cohort. Thus, providers previously concerned about the association between isotretinoin and suicide may feel more comfortable prescribing isotretinoin to patients who have severe or recalcitrant acne.
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Conflict of interest: None.
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The views expressed are those of the authors and do not necessarily represent the official position of the Food and Drug Administration.
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Reprints not available from authors.
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Correspondence: Diane K. Wysowski, PhD, Division of Drug Risk Evaluation I, HFD-430, Food and Drug Administration, Parklawn Building, Room 15B-08, Rockville, MD 20857. E-mail: [email protected].