| アブストラクト | BACKGROUND: Migraine has a high prevalence in the population and accounts for 12% of primary headaches. Ubrogepant is used for the treatment of acute migraine, and although some clinical trials have demonstrated the safety of Ubrogepant, its long-term safety in a large sample of the population remains to be investigated. METHODS: We collected data from the US Food and Drug Administration Adverse Event Reporting System (FAERS) database. We used reporting odds ratio (ROR), the proportional reporting ratio (PRR), the information component (IC) and the empirical Bayes geometric mean (EBGM) to evaluate Ubrogepant-induced adverse events (AEs). RESULTS: We screened out 2,067 reports of Ubrogepant as primary suspected (PS) and 6,190 reports of Ubrogepant-induced AEs as PS. Our results showed that Ubrogepant-induced AEs targeted 4 system organ classes (SOCs), detected 32 Preferred terms (PTs) signals in 9 SOCs, including common Ubrogepant label consistent with Migraine, Nausea, Somnolence, Paraesthesia oral and Dizziness, It also includes the AEs of Hemiparesis, Mental impairment, Dysstasia, Tinnitus, Chest pain, Cold sweat, Neck pain, etc. that have not been demonstrated in previous studies. CONCLUSIONS: Our study identified new AEs that have not been reported, which provides a new guidance to deepen the comprehension of the safety of Ubrogepant. |
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| ジャーナル名 | Expert opinion on drug safety |
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| 投稿日 | 2023/8/23 |
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| 投稿者 | Cao, Bing; Gu, Shanshan; Shen, Zhisen; Zhang, Yuna; Shen, Yiming; Chen, Hang |
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| 組織名 | Department of Otorhinolaryngology Head and Neck Surgery, Lihuili Hospital;affiliated to Ningbo University, Ningbo, Zhejiang, China.;Department of Otology and Skull Base Surgery, National Health Commission Key;Laboratory of Hearing Medicine (Fudan University), Shanghai City, P. R. China.;Department of Thoracic surgery, The Affiliated Lihuili Hospital, Ningbo;University, Ningbo, Zhejiang Province, P. R. China. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/37608560/ |
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