| アブストラクト | Vitiligo, an autoimmune disorder causing depigmented skin patches, includes two types, segmental (SV) and non-segmental (NSV). Previously, NSV was off-label treated using Calcineurine inhibitors (Tacrolimus and Pimecrolimus). In 2022, the FDA approved Ruxolitinib cream, targeting the JAK/STAT pathway for NSV treatment based on promising results. This research conducts a retrospective descriptive safety assessment of Tacrolimus, Pimecrolimus, and Ruxolitinib safety in vitiligo treatment, utilizing the FDA Adverse Event Reporting System (FAERS) database spanning the period from 2013 to 2023 and including patients aged 2 years and above, encompassing both brand and generic names. A total of 844 adverse event reports involving 388 patients were extracted and categorized into dermatological and systemic groups for analysis. Tacrolimus resulted in 12 hospitalizations, two life-threatening events, and four disabilities. Pimecrolimus exhibited urticaria and pigmentation disorders, with tooth fracture as the primary systemic event. Pericarditis was the predominant systemic side effect of Ruxolitinib, followed by anemia, headache, and urosepsis. Local dermatological side effects reported were generally mild, not warranting treatment cessation. In conclusion, vitiligo significantly impacts patients' psychological well-being, necessitating continuous post-marketing safety monitoring for topical medications. |
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| ジャーナル名 | Diseases (Basel, Switzerland) |
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| Pubmed追加日 | 2025/7/25 |
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| 投稿者 | Alqifari, Saleh F; Gari, Musaab Habibulla; Guo, Jeff J; Alamin, Shoroq; Esmail, Aya K; Esmail, Abdullah K; Hamad, Heba R; Aljabri, Ahmed; Alatawi, Amirah M; Albishi, Laila A; Alraddadi, Mohammed Olaythah; Hetta, Helal F |
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| 組織名 | Faculty of Pharmacy, University of Tabuk, Tabuk 47713, Saudi Arabia.;James L. Winkle College of Pharmacy, University of Cincinnati Academic Health;Center, Cincinnati, OH 45267, USA.;College of Medicine, Sulaiman Alrajhi University, Al Bukairiyah 52726, Saudi;Arabia.;Department of Pharmacy Practice, Faculty of Pharmacy, King Abdulaziz University,;Jeddah 22254, Saudi Arabia.;Department of Family and Community Medicine, Faculty of Medicine, University of;Tabuk, Tabuk 47713, Saudi Arabia.;Pediatric Department, Faculty of Medicine, University of Tabuk, Tabuk 47713,;Saudi Arabia.;Department of Internal Medicine, Faculty of Medicine, University of Tabuk, Tabuk;47713, Saudi Arabia.;Division of Microbiology, Immunology and Biotechnology, Department of Natural;Products and Alternative Medicine, Faculty of Pharmacy, University of Tabuk,;Tabuk 71491, Saudi Arabia. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/40709998/ |
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