Post-marketing Safety Evaluation of Lutathera ( 177 Lu-DOTATATE) : A Pharmacovigilance Analysis of FDA Adverse Event Reporting System.

BACKGROUND

Lutathera, a key therapy for gastroenteropancreatic neuroendocrine tumors, has demonstrated efficacy, but its real-world safety profile remains unclear. This study aims to conduct a comprehensive analysis of the adverse events (AEs) associated with Lutathera using FDA Adverse Event Reporting System (FAERS) data.

PATIENTS AND METHODS

A retrospective pharmacovigilance analysis was conducted using FAERS data from Q4 2019 to Q3 2024. AE reports involving Lutathera were identified, and a case/non-case approach was employed to evaluate AE signals using disproportionality analysis methods, including the reporting odds ratio and information component (IC). Patient demographics, time to AE onset, and system organ class (SOC) involvement were analyzed.

RESULTS

After data processing, a total of 4284 AE reports associated with Lutathera were analyzed. The median time to AE onset was 113.5 days. Lutathera-related AEs exhibited a notably high mortality rate, reaching as much as 31.2%. Statistically significant signals were detected across 13 SOCs and multiple preferred terms (PTs). Among the SOCs, the most pronounced signals were observed in the category of endocrine disorders. The leading PTs included nonspecific disorders (IC 025 : 5.92), carcinoid syndrome (IC 025 : 5.69), and carcinoid crisis (IC 025 : 5.62). Moreover, several PTs not documented in the drug's labeling were reported, such as encephalitis, intestinal ischemia, and disseminated intravascular coagulation.

CONCLUSIONS

Our study utilized real-world data to identify multiple risk signals associated with Lutathera, providing additional evidence to support its rational use. However, due to the inherent limitations of the FAERS database, further research is warranted to validate these findings.