Safety Profile of Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors: A Disproportionality Analysis of FDA Adverse Event Reporting System

The study analyzed 27,123 adverse event reports from the FDA database to assess the safety profile of EGFR-TKIs, including gefitinib, erlotinib, afatinib, and osimertinib. It found significant adverse events in the skin, nails, gastrointestinal tract, liver, eyes, and lungs, with unexpected reactions like "intestinal obstruction" and "hypokalaemia" for gefitinib and erlotinib, "hyponatraemia" for gefitinib, erlotinib, and afatinib, "alopecia" for erlotinib, and "hair growth abnormal" for afatinib. Skin toxicities were common, with high incidences of any grade skin reactions, and nail toxicity was also reported. Hair abnormalities, including alopecia, were noted in 0-13% of patients. The study emphasized the importance of pharmacovigilance and the need for real-world data to corroborate clinical observations, highlighting the limitations of using FAERS data alone to establish causality and the need for further clinical trials.