SURVEILLANCE OF ADVERSE DRUG REACTIONS TO TRADITIONAL CHINESE MEDICINES: A REAL-WORLD ANALYSIS FROM SHENZHEN, CHINA
Author(s)
Limin Li, Master of Chinese Medicinal Pharmacy1, Fenfang Wei, Msc2;
1Shenzhen Insititute of Pharmacovigilance and Risk Management, shenzhen, China, 2shenzhen institute of pharmacovigilangce and risk management, shenzhen, China
1Shenzhen Insititute of Pharmacovigilance and Risk Management, shenzhen, China, 2shenzhen institute of pharmacovigilangce and risk management, shenzhen, China
OBJECTIVES: To characterize the patterns and burden of adverse drug reactions (ADRs) associated with Traditional Chinese Medicines (TCMs) using data from a regional spontaneous reporting system in Shenzhen.
METHODS: A retrospective analysis was conducted on spontaneous ADR reports collected by the Shenzhen Institute of Pharmacovigilance and Risk Management in 2024. Reports involving TCM products (including herbal formulas, external preparations, and injectables) were extracted from the Guangdong Pharmacovigilance and Risk Control System. Descriptive statistics were used to analyze patient demographics, involved TCM products, ADR severity, and affected organ systems. Signal detection was performed on frequently reported products and serious cases.
RESULTS: Among 38,912 ADR reports, TCMs accounted for 1,731 cases (4.45%). Of these, 763 were serious (44.1%). The most frequently reported TCMs were Liu Shen Wan (85 cases), Xiaotong Tiega plaster (78 cases), and Zhengqing Fengtongning sustained-release tablets (21 cases). Serious TCM-related ADRs most commonly involved the blood system (31.53%), skin and appendages (17.44%), and gastrointestinal tract (12.50%). A notable cluster signal involving Zhengqing Fengtongning tablets highlighted hepatobiliary injury, leading to label review and risk communication.
CONCLUSIONS: TCMs contribute to a measurable burden of ADRs, with serious reactions occurring in a significant proportion of cases. Risk signals are often associated with specific formulations and routes of administration. These findings underscore the necessity for strengthened TCM-specific pharmacovigilance, including improved labeling, targeted monitoring of high-risk products, and enhanced training for healthcare professionals in recognizing and reporting TCM-related ADRs.
METHODS: A retrospective analysis was conducted on spontaneous ADR reports collected by the Shenzhen Institute of Pharmacovigilance and Risk Management in 2024. Reports involving TCM products (including herbal formulas, external preparations, and injectables) were extracted from the Guangdong Pharmacovigilance and Risk Control System. Descriptive statistics were used to analyze patient demographics, involved TCM products, ADR severity, and affected organ systems. Signal detection was performed on frequently reported products and serious cases.
RESULTS: Among 38,912 ADR reports, TCMs accounted for 1,731 cases (4.45%). Of these, 763 were serious (44.1%). The most frequently reported TCMs were Liu Shen Wan (85 cases), Xiaotong Tiega plaster (78 cases), and Zhengqing Fengtongning sustained-release tablets (21 cases). Serious TCM-related ADRs most commonly involved the blood system (31.53%), skin and appendages (17.44%), and gastrointestinal tract (12.50%). A notable cluster signal involving Zhengqing Fengtongning tablets highlighted hepatobiliary injury, leading to label review and risk communication.
CONCLUSIONS: TCMs contribute to a measurable burden of ADRs, with serious reactions occurring in a significant proportion of cases. Risk signals are often associated with specific formulations and routes of administration. These findings underscore the necessity for strengthened TCM-specific pharmacovigilance, including improved labeling, targeted monitoring of high-risk products, and enhanced training for healthcare professionals in recognizing and reporting TCM-related ADRs.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
RWD171
Topic
Real World Data & Information Systems
Disease
No Additional Disease & Conditions/Specialized Treatment Areas