| アブストラクト | BACKGROUND: Low-dose oral minoxidil (LDOM) is used to treat hair loss, but the literature on its safety profile is relatively sparse. AIMS: Using the FDA Adverse Event Reporting System (FAERS) database, we determined signals for adverse events (AEs) with LDOM use. METHODS: Four sets of case/noncase study disproportionality analyses were conducted to determine reporting odds ratio (ROR) for 10 AEs including pericardial effusion (PE). The oral minoxidil dose ranges were: (i) </=1.25 mg (i.e., 0-1.25 mg), (ii) </=2.5 mg (i.e., 0-2.5 mg), (iii) </=5 mg (i.e., 0-5 mg), and (iv) </=10 mg (i.e., 0-10 mg). RESULTS: For </=1.25 mg, we detected a signal for PE (ROR = 16.41, 95% CI: 2.29, 117.37, p < 0.05). For </=2.5 mg, the analyses detected a signal for PE (ROR = 13.30, 95% CI: 5.96, 29.68, p < 0.05); the ROR in the absence of cardiac impairment was 5.34 (95% CI: 1.33, 21.37, p < 0.05); in the presence of cardiac impairment, the ROR was 49.42 (95% CI: 18.27, 133.66, p < 0.05). A signal for PE was also detected at </=5 and </=10 mg. For PE, there was a significant (p < 0.05) association with a patient outcome of "life threatening" only at the </=10 mg dose range. CONCLUSIONS: Our study, the first FAERS-based signal detection study for LDOM, found significant associations between LDOM use and several AEs. In the absence of causal evidence, these correlations warrant more attention regarding safe use of LDOM. Until more safety data are available, we recommend using LDOM at the lowest effective dose (</=5 mg/day). |
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| ジャーナル名 | Journal of cosmetic dermatology |
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| 投稿日 | 2024/9/27 |
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| 投稿者 | Gupta, Aditya K; Bamimore, Mary A; Abdel-Qadir, Husam; Williams, Greg; Tosti, Antonella; Piguet, Vincent; Talukder, Mesbah |
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| 組織名 | Mediprobe Research Inc., London, Ontario, Canada.;Division of Dermatology, Department of Medicine, Temerty Faculty of Medicine,;University of Toronto School of Medicine, Toronto, Ontario, Canada.;Division of Cardiology, Women's College Hospital and University Health Network,;Toronto, Ontario, Canada.;Department of Medicine and Institute of Health Policy, Management and Evaluation,;University of Toronto, Toronto, Ontario, Canada.;Farjo Hair Institute, London, UK.;Miller School of Medicine, University of Miami, Miami, Florida, USA.;Division of Dermatology, Women's College Hospital, Toronto, Ontario, Canada.;School of Pharmacy, BRAC University, Dhaka, Bangladesh. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/39327649/ |
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