Comprehensive Study of Drug-Associated Severe Allergic Reactions: An Analysis of High-Risk Medications and Epidemiological Trends Based on the FAERS Database.

Abstract

Purpose: Drug-induced anaphylactic shock (DIAS) is a severe adverse drug reaction. This study aimed to identify drugs significantly associated with DIAS through the real-time updated analysis of large-sample data.

Methods: This retrospective cohort study analyzed 20,748,017 adverse event reports from the Food and Drug Administration Adverse Event Reporting System database spanning from the first quarter of 2004 to the fourth quarter of 2023 to identify the main drugs causing anaphylactic shock. Descriptive statistical analysis was used to report the basic characteristics, while disproportionality analysis was employed to assess the correlation between specific drugs and DIAS events using metrics such as the reporting odds ratio (ROR), proportional reporting ratio (PRR), and χ² test values. Additionally, detailed descriptive analyses were performed to examine yearly trends, sex and age distributions, and the sources and countries of reported DIAS events.

Results: There were a total of 21,073 DIAS events, accounting for 0.10% of all reports. The median weight of the DIAS patients was 70 kg, the median age was 55 years, and the incidence of DIAS was significantly higher among females (56.57%) than among males (35.24%). DIAS was primarily associated with indications such as anesthesia, sclerosis, and arthritis. The top 10 drugs most strongly associated with anaphylactic shock were amoxicillin, propofol, moxifloxacin, infliximab, omalizumab, carboplatin, paclitaxel, cefuroxime, ceftriaxone, natalizumab, and rocuronium bromide. Asymmetric analysis revealed that the top 10 drugs with the strongest signals were remifentanil, carboplatin, propofol, ceftriaxone, iopromide, atracurium, meloxicam, cefuroxime, desflurane, and ringer lactate. (all ROR > 3, PRR > 2, χ² > 4, P < 0.001).

Conclusions: Antibiotics, anesthetics, monoclonal antibodies (mAbs), and antitumor drugs are the main categories of drugs associated with anaphylactic shock. Specifically, high clinical vigilance should be given to β-lactam antibiotics, intravenous anesthetics, antitumor drugs, and mAbs. Future research on DIAS should further explore its mechanisms, evaluate risk factors, and develop effective prevention strategies to enhance the safety and efficacy of drug therapy.