Author: zhulikou431
The State Drug Administration of China (SDA) announced in the evening of May 29, 2018 the decision to revise the package insert of Bupleurum injection (as shown in the following figure). Besides adding warning and revision of adverse reaction, contraindication, and notice, what draws the greatest public attention is the "contraindicated for children" in the contraindication, for which the main reason is the multiple adverse reactions of the Bupleurum injection (see the following figure).
There are mainly three categories of TCM injection: one is the heat clearing and detoxifying category, mainly used to treat respiratory system diseases; two is the blood circulation promoting and stasis removing category, mainly used to treat cardiovascular and cerebrovascular diseases; three is the tonifying and qi-correcting category, mainly used to treat tumors. According to the data in 2017 Annual Report for National Adverse Drug Reaction Monitoring, among the suspected pharmaceutical products involved in the adverse drug reaction/event reports in 2017, the top 10 categories by TCM cases were separately: blood circulation promoting and stasis removing drugs in the blood-regulating formulae (31.1%), heat clearing and detoxifying drugs in the heat-clearing formulae (9.5%), qi and yin tonifying drugs in the tonic formulae (8.7%), cold drugs in the resuscitation formulae (8.2%), cold-pungent and diaphoretic drugs in the exterior releasing formulae (5.6%), heat clearing and dampness removing drugs in the dampness eliminating formulae (4.9%), wind dispelling and dampness eliminating drugs in the dampness eliminating formulae (3.0%), heat clearing and phlegm eliminating drugs in the phlegm-expelling formulae (2.3%), qi-tonifying drugs in the tonic formulae (1.7%), and qi-supplementing and blood-activating drugs in the blood-regulating formulae (1.5%); furthermore, TCM injections and TCM oral preparations separately accounted for 54.6% and 37.6%.
The safety problems of TCM injections are mostly caused due to adverse reactions thereof, including from the adverse reaction events of the Houttuynia cordata injection and Acanthopanax senticosus injection in the early days, to death event caused by Shuanghuanglian injection in 2009, to the emergency recall of Safflower injections and Xiyanping injections by the former CFDA due to serious adverse events that happened in many places of China in September 2017. The former CFDA announced on September 23 thereafter to halt use of Xiyanping injection.
There are the following root causes for the adverse reactions of TCM injections:
★Blind spot in prescription drug selection during TCM injection R&D: TCM injections are mostly compound products that use a large number of non-statutory varieties not from the pharmacopeia as the raw materials, of which the quality standard, chemical ingredient, and toxicity, etc. lack reference data and standards, directly threatening the quality stability and safety of TCM injections and increasing the risks of adverse reaction occurrence.
★Limitations of clinical trials before the marketing of TCM injections: the limitations mainly show as small number of clinical trial cases and short trial process, etc.
★Low quality standards for TCM injections: the quality standards fail to control the multiple ingredients of the injections.
★Backward production processes of TCM injections: modernization of TCM production is now advocated and some manufacturers have introduced advanced production equipment and improved production processes, however, there are still many old production processes of which the most serious impact is the impurity residual in TCM injections, eventually affecting the quality stability and use safety.
★Clinical use of TCM injections lacking standardization: this is also a common problem. The amount of clinical use of TCM injections has been greatly reduced in recent years as the TCM injection varieties are restricted, however, there are still non-standard clinical use phenomena such as irrational combination of Chinese and Western medicines, o...
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