| アブストラクト | BACKGROUND: Laxatives are widely used in the treatment of constipation, but they also have brought many adverse reactions to patients. METHODS: We conducted a pharmacovigilance analysis based on the United States Food and Drug Administration Adverse Event Reporting System (FAERS) database to analyze the adverse events of six constipation drugs (linaclotide, lubiprostone, prucalopride, naloxegol, naldemedine, and plecanatide) and to search for clinically meaningful adverse reaction signals. We used disproportionality analysis as the main analysis method to detect pharmacovigilance signals, which includes Frequentist methods and Bayesian methods. RESULTS: Among the reports of the six drugs, more adverse reactions were reported from females than males, and the number of adverse reactions reported was higher in the group of 60-89 years. Linaclotide had the lowest proportion of serious adverse event reports (4.38%), while naldemedine had the highest proportion of serious adverse event reports (25.57%). According to the classification of system organ classification (SOC), the number of gastrointestinal adverse events (N = 8321) was the largest. CONCLUSIONS: The adverse reactions of constipation drugs were mainly gastrointestinal symptoms such as diarrhea, abdominal pain and abdominal distension. Linaclotide has the highest safety, and more studies are needed to analyze the cardiovascular safety of lubiprostone. |
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| ジャーナル名 | Expert opinion on drug safety |
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| Pubmed追加日 | 2025/2/14 |
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| 投稿者 | Zhang, Wenyu; Wang, Hui; Yang, Shiwei; Pang, Xue; Hu, Wenqi; Zhang, Guang; Xin, Xuezhi |
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| 組織名 | The First Clinical Medical College, Shandong University of Traditional Chinese;Medicine, Jinan, Shandong Province, China.;Laboratory of Molecular Genetics of Aging & Tumor, Medicine School, Kunming;University of Science and Technology, Kunming, Yunnan Province, China.;Department of General Surgery, The First Affiliated Hospital of Shandong First;Medical University & Shandong Provincial Qianfoshan Hospital, Jinan, Shandong;Province, China.;Department of Health Management, The First Affiliated Hospital of Shandong First;Shandong Engineering Research Center of Health Management, Jinan, Shandong |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/39950440/ |
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