Traditional Chinese medicine and drug-induced anaphylaxis: data from the Beijing pharmacovigilance database

Background Traditional Chinese medicine (TCM) is one of the major triggers for drug-induced anaphylaxis (DIA). Objective We aimed to use the Beijing pharmacovigilance database (BPD) to analyze TCM-induced DIAs in Beijing, China. Setting Drug allergy case reports from the BPD provided by the Beijing Center for Adverse Drug Reaction Monitoring. Method Drug allergy cases from January 2004 to December 2014 were adjudicated. DIA triggered by TCMs were analyzed and compared with those triggered by non-TCM drugs by calculating the reported risk ratio (RRR). We also calculated the RRRs based on severe DIA and death outcomes. Main outcome measure TCMs implicated in DIAs were identified and compared with non-TCM drugs. Results TCMs accounted for 1651 (18.2%) of the total 9074 allergic cases, in which 84.4% (1393/1651) were triggered by injections. Of the TCM allergic cases, 8.5% (141) were DIAs and 7.3% (120) were severe DIAs, and three patients died from injections. The RRR between TCMs and non-TCM-induced DIAs was 0.63. When anaphylactic cases were compared between TCMs to the top four non-TCM drug triggers, RRRs were 0.73 (95% CI 0.61-0.87) for antibiotics, 0.36 (95% CI 0.29-0.44) for radiocontrast agents, 0.55 (95% CI 0.43-0.68) for chemotherapeutics, and 0.29 (95% CI 0.23-0.37) for biologics. Compared to TCM oral or topic formulations, TCM injections had higher RRRs in each of the above comparisons. Conclusion TCM was associated with a decreased risk of DIA compared to non-TCM drugs in drug allergy cases, and the risk was higher for TCM injections.