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Thyroid hyperplasia and neoplasm adverse events associated with GLP-1 receptor agonists in FDA Adverse Event
Abstract:
Glucagon receptor-like peptide 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 adjunct to diabetes therapy in patients with chronic kidney disease, presence or risk of atherosclerotic cardiovascular disease, obesity, and other cardiometabolic conditions. The weight loss seen in clinical trials has been explored further in healthy individuals, putting GLP-1 RAs on track to be the next weight loss treatment. 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 is warranted to quantify thyroid hyperplasia and neoplasms instances. In this study we analyzed over eighteen million reports from United States Food and Drug Administration Adverse Event Reporting System and identified 17,653 relevant GLP-1 RA monotherapy reports to provide the 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 inhibitor monotherapy.
Insights
Glucagon receptor-like peptide receptor agonists (GLP-1 RAs) show increased risks of thyroid hyperplasia and neoplasms. This finding is based on analysis of postmarketing safety data for GLP-1 RA monotherapy.
Area of Science:
- Endocrinology
- Pharmacovigilance
- Oncology
Background:
- Glucagon receptor-like peptide receptor agonists (GLP-1 RAs) are widely prescribed for type-2 diabetes and increasingly for weight management.
- Clinical guidelines recommend GLP-1 RAs for patients with chronic kidney disease, cardiovascular disease, and obesity.
- Concerns exist regarding thyroid cancer risk, highlighted by animal studies and human case reports, necessitating further safety data review.
Approach:
- Analysis of over 18 million reports from the FDA Adverse Event Reporting System (FAERS).
- Identification of 17,653 relevant GLP-1 RA monotherapy reports.
- Comparative analysis against sodium-glucose cotransporter-2 inhibitor (SGLT-2i) monotherapy data.
Key Points:
- GLP-1 RA monotherapy demonstrated a significantly increased propensity for thyroid hyperplasias and neoplasms.
- The study quantified instances of thyroid hyperplasia and neoplasms in patients using GLP-1 RAs.
- Findings suggest a potential link between GLP-1 RA use and thyroid abnormalities.
Conclusions:
- Postmarketing safety data indicates a heightened risk of thyroid hyperplasia and neoplasms with GLP-1 RA monotherapy.
- Further investigation into the thyroid safety profile of GLP-1 RAs is warranted given their expanding indications.
- This research provides crucial evidence for clinicians and regulatory bodies regarding GLP-1 RA safety.
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