| アブストラクト | BACKGROUND: FDA approved treatments for constipation-predominant irritable bowel syndrome (IBS-C) include secretagogues (Linaclotide, Lubiprostone, and Plecanatide) and a retainagogue (Tenapanor). The FDA Adverse Event Reporting System (FAERS) database collects suspected medication-related adverse events (AEs). RESEARCH DESIGN AND METHODS: Reports in FAERS from the date of each medication's FDA approval until 30 June 2024 were analyzed. Reports containing other suspected medications or a reason for use outside of IBS and/or constipation were excluded. RESULTS: Linaclotide was most associated with diarrhea (n = 2,082, 24.1%), abdominal pain (n = 815, 9.4%), abdominal bloating (n = 795, 9.2%), and nausea/vomiting (n = 266, 3.1%). Plecanatide was most associated with diarrhea (n = 137, 20.4%), abdominal pain (n = 76, 11.3%), abdominal bloating (n = 62, 9.2%), and nausea/vomiting (n = 34, 5.1%). Tenapanor was most associated with diarrhea (n = 51, 32.9%), abdominal pain (n = 13, 8.4%), and abdominal bloating and nausea/vomiting (n = 11 each, 7.1%). Lubiprostone was most associated with dyspnea (n = 221, 13.0%), nausea/vomiting (n = 161, 9.5%), chest pain (n = 157, 9.3%), abdominal pain (n = 85, 5.0%), and diarrhea (n = 79, 4.7%). CONCLUSIONS: This post-marketing analysis of the FAERS database revealed diarrhea, abdominal pain, bloating, and nausea/vomiting were the most frequently reported AEs across all medications. Novel findings include the potential for clinically significant dehydration from Linaclotide-induced diarrhea and Lubiprostone-associated dyspnea and chest pain. |
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| 組織名 | Department of Internal Medicine, Virginia Commonwealth University, Richmond,;Virginia, USA.;Center for Advanced Therapeutic Endoscopy (CATE), Porter Adventist Hospital/PEAK;Gastroenterology, Denver, CO, USA. |
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