Safety profile of lanreotide: a retrospective post-marketing pharmacovigilance study based on the real-world data from FAERS database

Purpose: Lanreotide, a class of synthetic somatostatin analogs (SSAs), is the recommended first-line treatment for neuroendocrine tumors (NETs) and acromegaly. Although the efficacy and safety of lanreotide have been established, limited real-world safety studies exist on this medication. This study sought to provide comprehensive assessment of the adverse effects associated with lanreotide administration in real-world clinical practice. Methods: We retrospectively extracted 17,499,090 reports of adverse drug events (ADEs) from the FAERS database. Four proportional imbalance analysis algorithms were utilized to identify lanreotide-related positive signals. This study employed subgroup analysis to assess the drug safety of lanreotide. Results: A total of 7795 ADEs and 1045 significant preferred terms (PTs) were identified when lanreotide was designed as the ‘primary suspected’ drug. In addition to common ADEs such as nausea, new ADEs such as urinary tract infection, pneumonia, and nasopharyngitis are also observed. Subgroup analyses showed that there were both commonalities and disparities in signal detection among gender, age, reporter, and dosage groups. The sensitivity analyses, excluding concomitant medications, confirmed the persistence of most positive signals. In addition, the combination drug analysis revealed that certain ADEs may occur with the additional treatment of lanreotide. Conclusion: This study performed a detailed comprehensive analysis of the post-marketing pharmacovigilance data for lanreotide, revealing valuable insights to optimize therapeutic apllications and mitigate potential adverse effects. These discoveries will advance the safe clinical use of lanreotide.