| アブストラクト | BACKGROUND AND OBJECTIVE: Psychiatric monitoring during isotretinoin treatment may be warranted. However, beyond depression and suicide, it is unclear which psychiatric adverse events (AEs) should be prioritized for monitoring. METHODS: Psychiatric AEs reported in FAERS from January 2004 to June 2024 were analyzed using disproportionality analysis, with reporting odds ratios >1 identifying positive signals. A clinical priority scoring system ranked the importance of these signals, and time-to-onset analysis evaluated their temporal patterns. Sensitivity analyses assessed the robustness of findings. RESULTS: Among the 19,412 cases of isotretinoin-related psychiatric AEs, 50 positive signals included over 20 cases each. Twenty-five important signals were identified and grouped into categories of depressive disorder, suicide and self-injury, anxiety disorder, mood change, bipolar disorder, psychosis, and affective disorder. Acne patients exhibited more important signals compared to nonacne patients. The median time-to-onset for moderate-priority signals was 80 days (IQR: 31, 265), displaying an early failure-type pattern (alpha = 0.55, 95% CI: 0.54-0.56). LIMITATION: Cross-sectional study. CONCLUSION: Mood disturbances, suicide and self-injury, and psychosis are key psychiatric AEs that require focused monitoring, particularly among acne patients. Intensified early monitoring, followed by continuous assessment, may help reduce the harm associated with these events. |
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| ジャーナル名 | Journal of the American Academy of Dermatology |
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| Pubmed追加日 | 2025/3/3 |
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| 投稿者 | Nie, Wenjia; Wu, Xiaopeng; Xia, Yuting; Zheng, Liyun; Lu, Hengcheng |
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| 組織名 | Dermatology Hospital of Jiangxi Province, Jiangxi Provincial Clinical Research;Center for Skin Diseases, Candidate Branch of National Clinical Research Center;for Skin Diseases, JXHC Key Laboratory of Skin Infection and Immunity, The;Affiliated Dermatology Hospital of Nanchang University, Nanchang, China.;Department of Psychiatry, Jiangxi Mental Hospital & Affiliated Mental Hospital,;Jiangxi Medical College, Nanchang University, Nanchang, Jiangxi, China; Nanchang;City Key Laboratory of Biological Psychiatry, Jiangxi Provincial Clinical;Research Center on Mental Disorders, Jiangxi Mental Hospital, Nanchang, Jiangxi,;China.;Department of Dermatology, Union Hospital, Tongji Medical College, Huazhong;University of Science and Technology, Wuhan, Hubei, China.;China. Electronic address: nkzly@foxmail.com.;Cardiovascular Research Institute of Jiangxi Province, Jiangxi Provincial;People's Hospital, The First Affiliated Hospital of Nanchang Medical College,;Nanchang, Jiangxi, China. Electronic address: hengchenglu@163.com. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/40024390/ |
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