A real-world pharmacovigilance study of four anti-non-small cell lung cancer drugs using the WHO-VigiAccess database

The efficacy of anlotinib, gefitinib, afatinib, and osimertinib in the treatment of non-small cell lung cancer is well established, but there are gaps in the safety evidence. This study used real-world data from the World Health Organization-VigiAccess database to evaluate the post-marketing adverse drug reactions (ADRs) of these 4 drugs. ADRs data for anlotinib, gefitinib, afatinib, and osimertinib were collected from the VigiAccess database up to April 30, 2025. To identify and analyze potential ADR signals, the study employed the reporting odds ratio, proportional reporting ratio, multi-item gamma Poisson shrinker, and Bayesian confidence propagation neural network methods. A total of 52,978 adverse event reports were collected for 4 medications, comprising 1642 reports for anlotinib, 10,294 for gefitinib, 12,493 for afatinib, and 28,549 for osimertinib. In the system organ class, all these 4 drugs are generally associated with skin and subcutaneous tissue disorders and gastrointestinal disorders. However, the focus of these 4 drugs varies. In the preferred term classification for specific symptoms, some adverse reactions have high frequency and strong signal intensity rankings, and others have high frequency but not particularly prominent signal intensity. The adverse reactions of anlotinib, gefitinib, afatinib, and osimertinib share certain commonalities and characteristics, which are basically consistent with those described in the drug labels. However, there are also some specific ADRs. Clinically, personalized medication can be carried out based on the characteristics of the drugs and the patient's condition.