| アブストラクト | OBJECTIVE: This study aimed to identify and characterize drugs associated with reports of head injury through a comprehensive analysis of the FDA Adverse Event Reporting System (FAERS) database. METHODS: A retrospective disproportionality analysis was conducted on FAERS reports from 2004 to 2023. Cases were identified using a single Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term: "Head Injury" (PT code 10019196). Four disproportionality methods-Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinker (MGPS)-were used to detect significant safety signals. RESULTS: Analysis of 26,485 head injury reports revealed a rising trend over time, with 84.12% being serious and 8.51% fatal. Strongest signals were detected for coagulation factors, notably vonicog alfa (ROR: 43.69) and pegylated factor VIII (ROR: 26.93). Chamomile also showed a significant association (ROR: 20.10). In contrast, warfarin had the highest report count (n = 429) but only a moderate signal strength (ROR: 6.77). CONCLUSION: This large-scale pharmacovigilance study identifies a strong association between coagulation factor therapies and reports of head injury. This signal most plausibly reflects confounding by indication rather than a direct prothrombotic mechanism. It also raises safety concerns regarding chamomile. These findings highlight the need for increased clinical vigilance and further investigation into these potential risks. |
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| ジャーナル名 | Brain and behavior |
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| Pubmed追加日 | 2026/6/15 |
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| 投稿者 | Guo, Jiaqi; Wei, Luming; Liu, Junfeng; Zhang, Jimei; Wang, He; Lu, Wanjun |
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| 組織名 | Department of Orthopedics, The Affiliated Hospital of Beihua University, Jilin;City, China.;Department of Oral Implantology, The Affiliated Stomatological Hospital of Xuzhou;Medical University, Xuzhou, China.;Department of Neurosurgery, Tonghua Central Hospital, Tonghua, China.;Department of Hepatobiliary and Pancreatic Surgery, Tonghua Central Hospital,;Tonghua, China.;Department of Neurology, The Affiliated Hospital of Beihua University, Jilin;Department of Neurology, Jiangdu People's Hospital Affiliated to Yangzhou;University, Yangzhou, China. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/42289946/ |
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