Details
Plecanatide is a guanylate cyclase-C (GC-C) agonist indicated for the treatment of chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C) in adults. The U.S. Food and Drug Administration (FDA) initiated this study in the Sentinel System using tree-based scan statistics to support safety signal identification for plecanatide. An active comparator study was conducted using a serotonin-4 (5-HT4) receptor agonist, prucalopride, as the comparator product. Find more information about the Prucalopride & Signal Identification Study here.
The goal of the study was to monitor non-pregnancy and non-cancer outcomes among new users of plecanatide. After evaluating the statistical alerts generated by this study in the context of other information, the FDA did not identify any new safety concerns and determined no further evaluation or action is warranted at this time. Statistical alerts are triaged in consideration of the study design, existing drug knowledge, therapeutic context, treated population, and potential public health impact. Alerts determined to be newly identified safety signals (NISS) follow the FDA’s Center for Drug Evaluation and Research manual of policies and procedures for NISS (MAPP 4121.3). Overall, the study did not identify any new safety concerns for plecanatide in this sample of real-world adult patients.