ORIGINAL RESEARCH article
Front. Pharmacol.
Sec. Gastrointestinal and Hepatic Pharmacology
Volume 16 - 2025 | doi: 10.3389/fphar.2025.1635792
This article is part of the Research TopicNew Insights into the Management of Chronic Idiopathic Constipation: From Physiopathology to Novel Therapeutic StrategiesView all articles
A pharmacovigilance study of the association between linaclotide/plecanatide and muscle spasms based on Food and Drug Administration adverse event reporting system
Provisionally accepted
- 北京大学国际医院, 北京市, China
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Background Linaclotide and plecanatide, as guanylate cyclase-C agonists, are effective treatments for irritable bowel syndrome with constipation and chronic idiopathic constipation. While their therapeutic benefits are well-established, the potential association between these drugs and the adverse reaction of muscle spasms remains understudied and controversial.Aim To evaluate the potential association between muscle spasms and linaclotide or plecanatide using real-world pharmacovigilance data.Method Cases of muscle spasms linked to linaclotide or plecanatide as primary suspected drugs were extracted from the Food and Drug Administration Adverse Event Reporting System (FAERS). Disproportionality analyses, including reporting odds ratio and information component, were employed to detect safety signals. Temporal patterns were assessed using Weibull distribution analysis.Results A total of 231 muscle spasms cases were identified (linaclotide: 182; plecanatide: 49). Females accounted for 72.3% of the cases (n=167), indicating a higher susceptibility. Disproportionality analysis revealed significant safety signals for both drugs, with plecanatide showing a stronger association (ROR=6.12, 95% CI: 4.61-8.11) compared to linaclotide (ROR=1.88, 95% CI: 1.63-2.18). Weibull analysis demonstrated an early failuretype curve (β < 1), suggesting a higher incidence shortly after treatment initiation.This study identifies a significant association between linaclotide/plecanatide and muscle spasms. The findings highlight the need for vigilance in high-risk populations and call for further investigation into the underlying mechanisms.
Keywords: linaclotide, plecanatide, Muscle spasms, Pharmacovigilance, FAERS
Received: 27 May 2025; Accepted: 17 Jul 2025.
Copyright: © 2025 Fan, li and lin. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: xiangchun lin, 北京大学国际医院, 北京市, China
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