Risk of Cutaneous Adverse Drug Reactions with GLP-1 Receptor Agonists: Insights from FAERS and Systematic Review
Author(s)
Shifa Taj, PharmD1, Mohammed Zuber, PharmD2, Nihala Jabeen, BS3, Muhammed Rashid, Ph.D4, Lorenzo Villa Zapata, PharmD, PhD2.
1Independent Researcher, Bengaluru, India, 2University of Georgia, Athens, GA, USA, 3Independent Researcher, Malappuram, India, 4University of Utah, Salt Lake City, UT, USA.
1Independent Researcher, Bengaluru, India, 2University of Georgia, Athens, GA, USA, 3Independent Researcher, Malappuram, India, 4University of Utah, Salt Lake City, UT, USA.
OBJECTIVES: GLP-1 receptor agonists (GLP-1 RAs) are widely used for type 2 diabetes and obesity management. Recent reports suggest an association between GLP-1 RAs and cutaneous adverse drug reactions (CADRs). This study aimed to assess GLP-1 RA-related CADRs using a disproportionality analysis of individual case safety reports (ICSRs) and a systematic review.
METHODS: A disproportionality analysis through retrospective case/non-case study was conducted using spontaneous reports in the FDA Adverse Event Reporting System (FAERS) database until Q3 2024. Signal detection followed the Evans criteria: events >2, Chi-Square (chisq) >4, and Proportional Reporting Ratio (PRR) >2. Additionally, a systematic review of the CADRs was conducted. Comprehensive literature searches in PubMed, Embase, Web of Science, and Grey Literature up to January 1, 2024, including case reports describing GLP-1 RA-associated cutaneous manifestations were included.
RESULTS: Disproportionality analysis identified strong signals for GLP-1 RA-related cutaneous adverse drug reactions (CADRs). Exenatide was associated with injection site nodules (n=1925; PRR=95.2; chisq=123934.7), while semaglutide showed a signal for injection site discharge (n=232; PRR=44.9; chisq=8742.3). Liraglutide was linked to injection site urticaria (n=197; PRR=6.0; chisq=797.6), dulaglutide to injection site hypersensitivity (n=61; PRR=8.4; chisq=373.4), and albiglutide to injection site rash (n=43; PRR=12.8; chisq=454.2). The systematic review included 32 descriptive studies involving 38 patients (20 females, and 18 males; aged 29-84 years). Frequently reported CADRs included morbilliform drug eruptions, injection site nodules, and bullous pemphigoid. Rare reactions such as angioedema and leukocytoclastic vasculitis were also observed. Dulaglutide was the most frequently implicated drug, followed by exenatide and liraglutide.
CONCLUSIONS: Findings from the FAERS database and systematic review demonstrate a significant association between GLP-1 RAs and CADRs, ranging from localized to rare systemic reactions. Carefully monitoring CADRs in patients using GLP-1 RAs is essential to optimizing treatment safety, improving outcomes, and ensuring the overall well-being of patients undergoing this therapy.
METHODS: A disproportionality analysis through retrospective case/non-case study was conducted using spontaneous reports in the FDA Adverse Event Reporting System (FAERS) database until Q3 2024. Signal detection followed the Evans criteria: events >2, Chi-Square (chisq) >4, and Proportional Reporting Ratio (PRR) >2. Additionally, a systematic review of the CADRs was conducted. Comprehensive literature searches in PubMed, Embase, Web of Science, and Grey Literature up to January 1, 2024, including case reports describing GLP-1 RA-associated cutaneous manifestations were included.
RESULTS: Disproportionality analysis identified strong signals for GLP-1 RA-related cutaneous adverse drug reactions (CADRs). Exenatide was associated with injection site nodules (n=1925; PRR=95.2; chisq=123934.7), while semaglutide showed a signal for injection site discharge (n=232; PRR=44.9; chisq=8742.3). Liraglutide was linked to injection site urticaria (n=197; PRR=6.0; chisq=797.6), dulaglutide to injection site hypersensitivity (n=61; PRR=8.4; chisq=373.4), and albiglutide to injection site rash (n=43; PRR=12.8; chisq=454.2). The systematic review included 32 descriptive studies involving 38 patients (20 females, and 18 males; aged 29-84 years). Frequently reported CADRs included morbilliform drug eruptions, injection site nodules, and bullous pemphigoid. Rare reactions such as angioedema and leukocytoclastic vasculitis were also observed. Dulaglutide was the most frequently implicated drug, followed by exenatide and liraglutide.
CONCLUSIONS: Findings from the FAERS database and systematic review demonstrate a significant association between GLP-1 RAs and CADRs, ranging from localized to rare systemic reactions. Carefully monitoring CADRs in patients using GLP-1 RAs is essential to optimizing treatment safety, improving outcomes, and ensuring the overall well-being of patients undergoing this therapy.
Conference/Value in Health Info
2025-05, ISPOR 2025, Montréal, Quebec, CA
Value in Health, Volume 28, Issue S1
Code
CO39
Topic
Clinical Outcomes
Topic Subcategory
Clinical Outcomes Assessment, Relating Intermediate to Long-term Outcomes
Disease
No Additional Disease & Conditions/Specialized Treatment Areas, SDC: Diabetes/Endocrine/Metabolic Disorders (including obesity), SDC: Sensory System Disorders (Ear, Eye, Dental, Skin)