Constipation-predominant irritable bowel syndrome treatment options Linaclotide, Lubiprostone, Plecanatide, and Tenapanor: analysis of the FDA Adverse Event Reporting System (FAERS) database.

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.