Background: GLP-1 receptor agonists (GLP-1RA) have demonstrated cardiovascular benefits, but the relationship between GLP-1RA and tumors is controversial. Recently, clinical trials reported higher rates of malignancy with semaglutide than control group. As real-world evidence of GLP-1RA-associated tumor risk is very limited, we explored the association of GLP-1RA and all types of neoplasms by mining the FDA Adverse Event Reporting System (FAERS) database.Methods: The FAERS data from the first quarter (Q1) of 2004 to the second quarter (Q2) of 2020 in the AERSMine were extracted to conduct disproportionality analysis, which was used by the proportional reporting ratio (PRR) to assess the relationship between GLP-1RA and all types of neoplasms. Then, the details of disproportionate GLP-1RA-associated tumor cases from Q1 2004 to Q2 2021 in the FAERS Public Dashboard were collected to analyze demographic characteristics.Results: A total of 8718 GLP-1RA-associated tumors were reported. Excluding cases with pre-existing tumors, other glucose-lowering drugs, and other GLP-1RA-related adverse events, diabetes cases with GLP-1RA as the main suspected drug were selected. GLP-1RA did not cause a disproportionate increase in all tumor cases (PRR 0.83) at the SOC level, and there was also no increase in most types of tumors associated with GLP-1RA at the HLGT/HLT levels. Significant signals were detected between GLP-1RA and certain tumors, including thyroid cancers [medullary thyroid cancer (PRR 27.43) and papillary thyroid cancer (PRR 8.68)], pancreatic neoplasms malignant (PRR 9.86), and islet cell neoplasms and APUDoma NEC (PRR 2.86). The combination of GLP-1RA with dipeptidyl-peptidase IV inhibitors (DPP4i) perhaps caused the increased reporting rate in some tumors.Conclusion: Our study provided new real-world evidence for oncology safety information of GLP-1RA. Given the wide use of GLP-1RA, clinicians should be well informed about important potential adverse events. Our pharmacovigilance analysis also prompted clinicians to raise concerns about potential tumor-related adverse effects when combining GLP-1RA with DPP4i.

AimsAvapritinib was first approved by the FDA in January 2020 and represents the first precision‐targeted drug for gastrointestinal stromal tumours. However, there is a lack of large‐scale data relating to adverse events (AEs) related to its use. We aimed to explore the avapritinib‐related AEs in real‐world practice based on the post‐marketing data.MethodsWe extracted all avapritinib‐related reports submitted to the FDA Adverse Event Reporting System (FAERS) by June 2022. Based on disproportionality analysis and Bayesian analysis, we then calculated the reporting odds ratio (ROR), proportional reporting ratio (PRR), information component (IC) and empirical Bayes geometric mean (EBGM) to evaluate whether there is a significant association between avapritinib and AEs. Gender, age and time to onset were comparable between haemorrhage/non‐haemorrhage, serious/non‐serious, death/non‐death AEs, respectively.ResultsIn total, 3120 cases related to avapritinib were documented in the FAERS database, and 44% were reported within 30 days of commencing avapritinib. A total of 331 different AE signals were detected, and no significant differences between males and females was identified. Although the number of AEs associated with an abnormal skin texture and executive dysfunction was small, the signal intensity is high, suggesting that these events are strongly correlated with avapritinib. Subgroup analysis showed that elderly male patients were more likely to suffer from serious AEs compared to females (P < .01), but there was no significant difference between the haemorrhage group and the non‐haemorrhage group. Analysis of fatalities due to avapritinib‐related AEs indicated that sex, age and time‐to‐onset were all significantly related to death (P < .05).ConclusionOur study provides a more precise description of the incidence and characteristics of AEs after using avapritinib, clinicians should be particularly careful when prescribing avapritinib to elderly male patients, especially within the 30 days.

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