Comprehensive analysis of adverse drug reactions associated with teduglutide: post-marketing insights and safety implications.

Background: Intestinal failure often necessitates teduglutide, a glucagon-like peptide-2 (GLP-2) analog that enhances intestinal adaptation by increasing absorptive surface area, thereby reducing reliance on intravenous supplementation (IVS). This study analyzes adverse drug reactions (ADRs) associated with teduglutide when used to treat short bowel syndrome (SBS) to inform clinical practice and enhance post-marketing surveillance.

Research design and methods: Retrospective analysis was conducted using the FDA Adverse Event Reporting System (FAERS) database. ADRs reported from teduglutide's FDA approval in 2012 through 20 August 2024 were analyzed using descriptive statistics and presented as [N (%)] or [median (IQR)].

Results: Of the 4,533 reports, 2,669 were females, and patients had a median age of 56 years, with 2,787 reports involving hospitalization and 443 associated with death. Gastrointestinal ADRs were the most frequently reported (N = 3,881), followed by infections (N = 2,273), cardiovascular events (N = 1,318), weight changes (N = 754), neuropsychiatric concerns (N = 651), and device-related infections (N = 618) were prominent. Mortality associated ADRs included infections (N = 222), gastrointestinal events (N = 172), and cardiovascular complications (N = 132).

Conclusions: Teduglutide is associated with significant ADRs necessitating vigilant monitoring while managing SBS patients, particularly for gastrointestinal health and infection risks. FAERS data limitations restrict causality determination, highlighting the need for further research to optimize safety.