Safety Concerns of Traditional Chinese Medicine Injections Used in Chinese Children

OBJECTIVE: To explore risks underlying traditional Chinese medicine (TCM) injection-related adverse drug reactions (ADRs) in Chinese children, and to discuss the implications of postmarketing reevaluation studies. METHODS: We identified potential cases of exposure to TCM injections for children (<18 years of age) and adults (18 years and upwards) from database of ADRs. First, the associations between TCM injection-related ADRs and three administration routes (i.e., intravenous or intramuscular administration, oral administration, and external use) and the imbalance of TCM injection-related ADRs between the paediatric and adult populations were tested using the Chi-square (χ(2)) test. Second, the proportional reporting ratio (PPR) was applied to identify statistically significant associations between drugs and anaphylactic shock in the paediatric population. RESULTS: The χ(2) test revealed that the highest frequency of paediatric ADRs was due to 5 types of herbal injections (i.e., Shuanghuanglian (SHL), Yuxingcao (YXC), Qingkailing (QKL), Xiyanping (XYP), and Reduning (RDN) herbal injections) (P<0.000), and the reports of ADRs attributed to the XYP and RDN herbal injections in children accounted for a greater proportion than the reports for adults (P<0.000). The PPR identified 5 types of herbal injections-anaphylactic shock pairs (i.e., the SHL, XYP, QKL, YXC, and Fufang Danshen herbal injections) that met the minimum criteria (i.e., a PPR of at least 2 and χ(2) of at least 4 and three or more cases), which suggested that TCM injections were significantly associated with anaphylactic shock. CONCLUSIONS: TCM injections pose graver risks to the paediatric population than the adult population. To achieve optimal benefits and minimal risk to children treated with TCM injections, we suggest reevaluating the effectiveness and safety, monitoring the risks, and promoting rational use of TCM injections in Chinese children.