Details
Prucalopride is a serotonin-4 (5-HT4) receptor agonist indicated for the treatment of chronic idiopathic constipation (CIC) 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 prucalopride. An active comparator study was conducted using a guanylate cyclase-C agonist, plecanatide, as the comparator product. Find more information about the Plecanatide & Signal Identification Study here.
The goal of the study was to monitor non-pregnancy and non-cancer outcomes among new users of prucalopride. 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 prucalopride in this sample of real-world adult patients.