Based on the FDA Adverse Event Reporting System Database,a Study on Signal Mining of Adverse Events for Guanylate Cyclase-C Receptor Agonists

Abstract

Objective:

To analyze and evaluate adverse drug event (ADE) signals for two GC-C receptor agonists, Linaclotide and Plecanatide, thereby enhancing understanding of their clinical safety.

Methods:

Data on adverse reactions associated with Linaclotide and Plecanatide were extracted from the FDA Adverse Event Reporting System (FAERS) for the period from Q1 2013 to Q4 2023. Signal detection was performed using the Reporting Odds Ratio (ROR) and the Proportional Reporting Ratio (PRR).

Results:

A total of 12 275 ADE reports for Linaclotide and 811 for Plecanatide were retrieved, resulting in 28 123 and 2230 ADE signals, respectively, across 24 and 19 System Organ Classes (SOCs). Both drugs predominantly exhibited gastrointestinal ADEs, including abdominal pain, bloating, and diarrhea. Linaclotide was associated with signals for urinary retention, incontinence, and bladder pain, which are not documented in its prescribing information. Plecanatide demonstrated signals for muscle spasms and sleep disorders, also absent from its instructions. Additionally, both drugs revealed signals related to water and electrolyte disorders.

Conclusion:

Clinical utilization of GC-C receptor agonists should take into account not only the prevalent gastrointestinal ADEs but also emerging signals associated with the urinary system, metabolic and nutritional disorders, and the nervous system. A comprehensive understanding of these signals is essential for evaluating medication risks and ensuring appropriate drug administration.