Post-marketing safety assessment of constipation drugs: a real-world pharmacovigilance study based on FAERS database.

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Tác giả: Wenqi Hu, Xue Pang, Hui Wang, Xuezhi Xin, Shiwei Yang, Guang Zhang, Wenyu Zhang

Ngôn ngữ: eng

Ký hiệu phân loại: 577 Ecology

Thông tin xuất bản: England : Expert opinion on drug safety , 2025

Mô tả vật lý:

Bộ sưu tập: NCBI

ID: 57714

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 ( 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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