Glucagon‐like peptide‐1 analogues and thyroid cancer: An analysis of cases reported in the European pharmacovigilance database
Open accessAbstract
WHAT IS KNOWN AND OBJECTIVE: The use of glucagon-like peptide-1 (GLP-1) analogues has been linked to the risk of thyroid cancer. Spontaneous reports can provide information about rare adverse events occurring after the time of marketing. Our objective was to detect, from the European pharmacovigilance database (EudraVigilance), a signal of thyroid cancer during GLP-1 analogues treatment in patients with diabetes. METHODS: Herein, we analysed all reports of thyroid cancer reported with GLP-1 analogues in EudraVigilance database from their first marketing authorization till 30 January 2020. A case/non-case method was used to assess the association between thyroid cancer and GLP-1 analogues, calculating proportional reporting ratios (PRRs) and their 95% confidence interval (CI) as a measure of disproportionality. The cases were identified with Medical Dictionary for Regulatory Activities (MedDRA) version 22.1. RESULTS AND DISCUSSION: There were 11 243 cases of thyroid cancer and related preferred terms (PTs) in the 6 665 794 reports recorded in EudraVigilance during the study period. GLP-1 analogues were involved in 236 cases. Exenatide, liraglutide and dulaglutide met the criteria to generate a safety signal, suggesting that thyroid cancer is reported relatively more frequently in association with these drugs than with other medicinal products. The association was strongest for liraglutide followed by exenatide with PRR of 27.5 (95% CI, 22.7-33.3) and 22.5 (95% CI, 17.9-28.3), respectively. Disproportionality was also observed for GLP-1 analogues and individual identified preferred term, that is thyroid cancer (N = 111), medullary thyroid cancer (N = 64) and thyroid neoplasm (N = 46) with PRR of 14.4 (95% CI, 11.8-17.4), 221.5 (95% CI, 155.7-315.1) and 35.5 (95% CI, 25.9-48.5), respectively. WHAT IS NEW AND CONCLUSIONS: Our findings showed disproportionality for thyroid cancer, medullary thyroid cancer and thyroid neoplasm in patients treated with GLP-1 analogues. We have found evidence from spontaneous reports that GLP-1 analogues are associated with thyroid cancer in patients with diabetes.
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Pharmacovigilance databases reflect nonsubstantiated events reported by individuals and attributed to a particular drug; they do not establish a causal or even an association relationship between a drug and the event, serving instead for hypothesis generation.
“However, these databases reflect nonsubstantiated events reported by individuals and attributed—by those individuals—to a particular drug.61–63 They do not establish a causal or even an association relationship between a drug and the event, serving instead for hypothesis generation and prompt for future investigation of disproportional increased reporting of events.”
From Glucagon-Like Peptide-1 Receptor Agonists and Thyroid Cancer: A Narrative Review (2024) · cites this paper as [61]
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Experimental — accuracy not yet measuredIn the European Pharmacovigilance Database, the thresholds for reporting a new safety signal were fulfilled for exenatide, liraglutide, and dulaglutide as thyroid cancer was reported relatively more frequently with these drugs compared with all other drugs in the database.
“The investigators calculated the proportional report ratio for GLP-1 RA and thyroid cancer and found the thresholds for reporting a new safety signal were fulfilled for exenatide, liraglutide, and dulaglutide as thyroid cancer was reported relatively more frequently with these drugs compared with all other drugs in the database.61”
From Glucagon-Like Peptide-1 Receptor Agonists and Thyroid Cancer: A Narrative Review (2024) · cites this paper as [61]
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- Authors
- Mali, G., Ahuja, V., & Dubey, K.
- Affiliations
- Jamia Hamdard (IN)
- Sun Pharma (India) (IN)
- Corresponding author
- Dubey, Kiran
- Venue
- Journal of Clinical Pharmacy and Therapeutics
- Publisher
- Wiley
- Published
- 2020-09-14
- Volume
- 46
- Issue
- 1
- Pages
- 99-105
- ISSN
- 0269-4727 (ISSN-L)
- 1365-2710
- OpenAlex
- W3084829832
- Semantic Scholar
- 4c101ca11813393f38c3b9703b509d0bc2839c13
- Cited by
- 44
- References
- 35
- Citations by year
- 2026: 9 · 2025: 11 · 2024: 10 · 2023: 10 · 2022: 3 · 2021: 1
- FWCI
- 2.46
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- Locations
- Journal of Clinical Pharmacy and Therapeutics (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Thyroid Cancer Diagnosis and Treatment
- Keywords
- glucagon-like peptide-1 analogues, thyroid cancer, medullary thyroid carcinoma, liraglutide, exenatide, dulaglutide, diabetes mellitus, adverse drug reactions, pharmacovigilance, disproportionality analysis, proportional reporting ratio, drug safety signals, EudraVigilance, drug-induced cancer risk
- MeSH terms
- Adolescent, Adult, Aged, Aged, 80 and over, Diabetes Mellitus, Type 2, Europe, Female, Humans, Hypoglycemic Agents, Male, Middle Aged, Thyroid Neoplasms, Databases, Factual, Glucagon-Like Peptide 1, Young Adult, Pharmacovigilance
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