Thyroid hyperplasia and neoplasm adverse events associated with GLP-1 receptor agonists in FDA Adverse Event Reporting System
ABSTRACT
Background:
Glucagon-like peptide-1 receptor agonists, GLP-1 RAs, are one of the most commonly used drugs for type-2 diabetes mellitus. The clinical guidelines recommend GLP-1 RAs as an adjunct to diabetes therapy in patients with chronic kidney disease, presence or risk of atherosclerotic cardiovascular disease, and obesity. The weight loss observed in clinical trials has been explored further in healthy individuals, putting GLP-1 RAs on track to be the next weight loss treatment.
Objective:
Although the adverse event profile is relatively safe, most GLP-1 RAs come with a labeled black boxed warning of the risk of thyroid cancers, based on animal models and some postmarketing case reports in humans. Considering the increasing popularity of this drug class and its expansion into a new popular indication, a further review of most recent postmarketing safety data was warranted to quantify thyroid hyperplasia and neoplasms instances.
Methods:
GLP-1 RA patient reports from FDA Adverse Event Reporting System database were analyzed using reporting odds ratios and 95% confidence intervals.
Results:
In this study we analyzed over eighteen million reports from United States Food and Drug Administration Adverse Event Reporting System and provided evidence of significantly increased propensity for thyroid hyperplasias and neoplasms in patients taking GLP-1 RA as monotherapy when compared to patients taking sodium-glucose cotransporter-2 inhibitors monotherapy.
Conclusions:
GLP-1 receptor agonists, regardless of indication, are associated with over 10-fold increase in thyroid neoplasms and hyperplasias adverse event reporting when compared to SGLT-2 inhibitors. Clinical Trial: N/A
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