A real-world pharmacovigilance assessment of drug-related carcinoembryonic antigen increase

The purpose of this study was to explore the risks associated with drugs that lead to drug-related carcinoembryonic antigen (CEA) increased by data from the Food and Drug Administration Adverse Event Reporting System. The adverse event reports associated with drugs induced CEA increase extracted from January 2004 to December 2024. Reporting odds ratio, empirical Bayes geometric mean, proportional report ratio, and Bayesian confidence propagation neural network were used to analyze the data disproportionation. The results showed that a total of 49 drugs with positive signals were identified, which involved 44 antitumor therapeutics and 5 non-tumor therapeutics. Results of the Bayesian confidence propagation neural network method showed that 83.67% (41/49) of drugs were at high risk of CEA increased. And dacomitinib, regorafenib, fruquintinib, vandetanib, and panitumumab were the top 5 drugs with high risk. Non-antitumor drugs were all moderate risk, involving atorvastatin, zoledronic acid, amiodarone hydrochloride, lithium, and teduglutide. Adverse events occurred primarily 90 days and later. Drug-related CEA increased is more common in women, and which mainly affects people over the age of 60. The number of related adverse event reports increased year by year. The results of this study provided the relevant basis for pharmacovigilance, and provided the basis for strengthening drug safety and making correct drug decision in clinical practice.