Parents note that another common drug for children is banned!

[China Pharmaceutical network industry trends] recently, the State Food and Drug Administration announced that according to the results of adverse drug reaction monitoring and safety evaluation, in order to further protect the public drug safety, it was decided to add warning words to the instructions of Bupleurum injection, revise the adverse reactions, taboos, precautions, etc., and clearly point out that children are forbidden to use Bupleurum injection According to the revision requirements of Chaihu Injection manual, warning words should be added: the adverse reactions of this product include anaphylactic shock, which should be used in the medical institutions with rescue conditions, and the user should have received the training of anaphylactic shock rescue In case of anaphylactic reaction or other serious adverse reactions, the drug should be stopped immediately and treated in time The "contraindications" should include: 1 Those who are allergic to this product or contain Bupleurum preparations and ingredients or have a history of serious adverse reactions should not be allowed 2 Disabled for children The announcement also reminded that Chaihu Injection is a prescription drug Patients should strictly follow the doctor's instructions and read the instructions carefully before using Chaihu Injection can be said to be the senior product in the market of traditional Chinese medicine injection In the past 70 years, Chaihu Injection has been widely used in the treatment of children's cold and fever In addition, Chaihu Injection is widely recognized by doctors and patients because of its fast curative effect and low price According to the background search statistics of China's food and drug administration, there are 77 approval numbers of Bupleurum injection in China, belonging to 73 enterprises Among them, Henan Kanghua Pharmaceutical Co., Ltd., Henan Runhong Pharmaceutical Co., Ltd., Sinopharm and Henan Fushen Pharmaceutical Co., Ltd have strong competitiveness and high market concentration The announcement means that none of these pharmaceutical companies can occupy the market of children's medicine any more So, why is Chaihu Injection stopped for children? According to the industry, it is mainly because of the risk of drug safety, some children will have serious adverse reactions after use Secondly, compared with oral medication, the severity of adverse reactions is significantly higher than oral medication, because there is no absorption problem In addition, the industry believes that Bupleurum injection, as a traditional Chinese medicine injection, must be extracted from traditional Chinese medicine Sometimes, its ingredients are not clear, and there may be many kinds of ingredients If the patient is allergic to one of the ingredients, it is not suitable to use the drug Therefore, we need to further explore the standardization of Chinese patent medicine injection in China "From all levels, no matter managers, manufacturers and hospital medical institutions, they are carrying out standardized management of Chinese patent medicine injection, including early research and development, process improvement and clinical adverse reactions collection and reporting, which is further standardizing the process." According to the industry, from the other side of the drug's ban on children's injection, this is to standardize the management of traditional Chinese medicine injection, and also to promote the further standardization of traditional Chinese medicine, so as to further step onto the world stage In recent years, the safety of traditional Chinese medicine injections has attracted more and more attention According to the annual report of national ADR monitoring issued by China's drug regulatory department, ADRs of traditional Chinese medicine injection account for more than half of ADRs of traditional Chinese medicine in recent years With the safety problems of traditional Chinese medicine injection becoming more and more prominent, the supervision of relevant departments is also becoming more and more strict For example, in October 2017, the opinions on deepening the reform of review and approval system to encourage innovation of medical devices for drugs was released, which proposed that the review and approval of drug injection will be strictly enforced It can be predicted that in the future, the pressure faced by pharmaceutical injection manufacturers will also increase.