Chinese medicine injection re exposure safety events, high risk can delisting?

Source: on April 28, 2015, caixin.com, Jiangsu and China Pharmaceutical recalled more than 30000 Shengmai injection, which was not the first safety problem of the drug The national ADR monitoring center case report database received more than 500 reports in eight years; and 2006 Since, there have been many Chinese medicine injections such as Houttuynia cordata, Ciwujia injection, Yinzhihuang injection, Shuanghuanglian injection and so on For more than 70 years since the invention of traditional Chinese medicine injection, it has been faced with controversy and frequent adverse events, but it has never been able to cure Jiangsu Suzhong Pharmaceutical Group Co., Ltd has had adverse reactions again, and the safety of traditional Chinese medicine injection has aroused concern again On April 25, the State Food and Drug Administration issued a notice that the Shengmai injection produced by Jiangsu Suzhong Pharmaceutical Group Co., Ltd (hereinafter referred to as Suzhong Pharmaceutical Group) had an adverse event in Guangdong, and some patients suffered from shivering and fever after taking the medicine At present, the pharmaceutical company has been asked to recall more than 30000 zhishengmai injection batches involved The head of the group told Caixin that all batches of injection involved had been recalled by manufacturers According to the information from Jiangsu food and drug administration, at present, no adverse reactions have been reported from other places except Guangdong As for the cause of the problem, the relevant departments are still investigating Although the injection of traditional Chinese medicine has many troubles, there are still many supporters They believe that traditional Chinese medicine injection has outstanding performance in cardiovascular and cerebrovascular diseases, tumors, bacterial and viral infections, and low cost, which is widely recognized by patients However, the opponents believe that the clinical application of all traditional Chinese medicine injections should be stopped immediately, and the key problems such as whether the injection of unknown ingredients into human body has definite curative effect, unknown toxic and side effects, and rough preparation process should be treated with a scientific attitude and method According to the notice on the official website of the General Administration of food and drug, recently, some patients in Guangdong province suffered from shivering and fever after using Shengmai Injection (batch number: 14081413) produced by Suzhou Zhongyao group After inspection, it was found that the batch of drug pyrogen did not meet the requirements, and the General Administration of food and drug asked Jiangsu food and drug administration to intervene in the investigation According to the investigation, the batch of Shengmai injection produced by Suzhong Pharmaceutical Group was produced on August 14, 2014, valid until August 13, 2016, with a total of 37638 pieces According to the survey, it is sold to 9 provinces (regions) including Jiangsu (2400), Zhejiang (13788), Anhui (12), Fujian (12), Shandong (417), Guangdong (9954), Hainan (15), Sichuan (7200), Xinjiang (3840) According to the requirements of the State Food and drug administration, Jiangsu food and drug administration shall supervise and ensure the recall and destruction of all problematic drugs; at the same time, it shall supervise the enterprises to thoroughly investigate the causes of drug quality problems, rectify the identified causes, and shall not resume production until the causes are identified and the rectification is in place, and the resumption of production shall be reported to the General Administration for filing In addition, the illegal behaviors of the enterprise shall be filed and dealt with according to law Jiangsu Sinopharm group, headquartered in Taizhou City, Jiangsu Province, has 6 holding companies with a total assets of 1 billion yuan and more than 3000 employees According to its official website, the enterprise covers more than 180 varieties of natural drugs, chemical drugs, marine drugs and biochemical drugs In recent years, the company's performance has increased by more than 40% every year Su Zhong Pharmaceutical Group has successfully developed more than 16 national three categories Exclusive patent new drugs, including Zhichuanling injection, huangkuijiao, Qingxuan Zhike granules, Yihechun oral liquid, etc Jiangsu and China Pharmaceutical Group said that, in addition to the more than 30000 injections being recalled, there were no more batches of problematic products entering the market After the occurrence of adverse reactions, Guangdong inspected many batches of products, and finally screened out the batch of products in question The enterprise has informed dealers and medical institutions to stop selling, stop using, off shelf and recycle the batch of products in question In addition, the enterprise used retained samples to inspect four batches of products adjacent to the problem batch According to the 24 day inspection report, no problems were found in the adjacent batches of products for the time being At present, the factory has stopped producing the injection and tested all 53 batches of products in the production line and inventory, which may take more than a week The test results will be released to the society at that time More than 500 cases of adverse reactions of Shengmai Injection in eight years are a kind of traditional Chinese medicine injection, mainly composed of red ginseng, Ophiopogon japonicus and Schisandra chinensis The clinical indications are mainly hemorrhagic shock, coronary heart disease, angina pectoris, heart failure, arrhythmia, pulmonary heart disease and other cardiovascular diseases Because it can reduce blood viscosity and platelet aggregation, and has antithrombotic effect, it is used in the treatment of cerebral infarction and myocardial infarction According to the notice on the official website of the State Administration of food and drug, the pyrogen of Shengmai Injection (batch number: 14081413) produced by Suzhou Zhongyao group does not meet the requirements Zhao Qi, director of ADR Monitoring Office of Jiangsu food and drug administration, said the heat source was generated in the drug production process The raw materials for drug production, our environment and even the air we breathe are not sterile, so there is a sterilization link in the drug production process However, after some bacteria, molds and other microorganisms are eliminated, the cells are destroyed, and the endotoxin of microorganisms will still be released These endotoxin will cause the function of human defense mechanism after entering the human body, and make the human body appear shivering, fever and other symptoms These remnants of sterilization are heat sources Some oral drugs and other preparations allow bacteria and other microorganisms to exist in a certain range, but for injection, the heat source is absolutely prohibited, that is to say, as long as the heat source is detected in injection, it is unqualified A senior manager of a traditional Chinese medicine injection plant told Caixin that the quality control of traditional Chinese medicine injection is a key issue, because injection is a way of injection, which directly enters the body without absorption through digestive tract, so the quality control must be strict However, most of the traditional Chinese medicine injections are made from the raw materials of herbs or decoction pieces after extraction and refinement There are impurities objectively, the content of effective substances is quite different, and it is easy to bring into pyrogen It is not the first time that Shengmai injection has safety problems According to the data of ADR case report database of national ADR monitoring center, among the safety problems of Shengmai injection, severe allergic reactions are the most prominent, especially anaphylactic shock, severe allergic reactions and other serious adverse reactions From January 1, 2004 to September 30, 2011, a total of 508 cases of serious adverse reactions / events of Shengmai injection were received in the case report database of national ADR monitoring center According to the analysis of adverse reactions / events report of Shengmai Injection in the National Center database, there are unreasonable use of the product in clinical, such as over dose use, mixed use, allergic constitution use, etc Whether the traditional Chinese medicine injection can withdraw from the market or not has always been faced with the "dispute of saving and abolishing" According to the annual report on ADR monitoring in 2013 released by the State Food and drug administration, the growth rate of ADR report of traditional Chinese medicine injection has increased compared with that in 2012 The top 10 injections in the report are Qingkailing injection, Shenmai injection, Danshen injection, Shuanghuanglian injection, Xiangdan injection, Xuesaitong injection, Mailuoning injection, Shuxuening injection, Shengmai injection and Huangqi injection Since 2006, many traditional Chinese medicine injections, such as Houttuynia cordata, Ciwujia injection, Yinzhihuang injection, Shuanghuanglian injection, have had fatal adverse events Since September 2014, Tongren Hospital, Chaoyang Hospital, Tiantan Hospital, etc in Beijing no longer use traditional Chinese medicine injections However, on dingxiangyuan, the largest medical platform in China, some doctors clearly indicated that several traditional Chinese medicine injections are high-risk and not recommended It is believed that traditional Chinese medicine injection plays an irreplaceable role in the field of clinical emergency Zhang Boli, academician of Chinese Academy of engineering, once said that traditional Chinese medicine injection has obvious advantages in cardiovascular system, anti-tumor, anti bacterial and anti viral infection In primary hospitals, traditional Chinese medicine injection is popular because of its cheap and effective "It's too early to make a conclusion whether it's more dangerous In the future, pharmaceutical technology will be more advanced, analytical methods will be more scientific, and there may be more pertinent conclusions." The top management of the Chinese medicine injection plant said that about 400 million people use Chinese medicine injection every year in China, "it is impossible to waste it" Zhou Chaofan, a researcher at the Chinese Academy of traditional Chinese medicine, objected He told Caixin, "it is still unknown that the effectiveness and safety of extracting so many ingredients from traditional Chinese medicine are unknown After intravenous injection, they bypass the gastrointestinal barrier and enter the blood directly There must be a safety risk." Zhou Chaofan said that there are nearly 10000 kinds of traditional Chinese medicine, and there are only 120 kinds of traditional Chinese medicine injection, accounting for less than 2% of the total Chinese medicine, but the adverse drug reactions account for about 70% of the total Chinese medicine adverse reactions In recent years, under the promotion of interests, many businesses have played down the concept that traditional Chinese medicine also has toxicity In fact, in the adverse drug reaction report issued by the State Food and drug administration, traditional Chinese medicine injection accounts for more than 80% of the serious reports of traditional Chinese medicine Traditional Chinese medicine injection is still the main risk of traditional Chinese medicine Disputes continue, the traditional Chinese medicine injection is still rapidly increasing production According to the statistics of prospective industry research institute, the compound growth rate of traditional Chinese medicine injection in the past five years is about 22% Although the growth rate is lower than the previous 30%, it is still higher than the growth rate of 15.78% of traditional Chinese medicine and 18.23% of the whole drug market At present, there are 303 enterprises in China with production approval documents of 134 traditional Chinese medicine injection varieties and 1255 different dosage forms, including more than 50 commonly used varieties In 2012, the market size of traditional Chinese medicine injection was about 32 billion Zhou Chaofan pointed out that "the high rate of return on the development, production and sales of traditional Chinese medicine injections has prompted pharmaceutical companies to compete for the production line of traditional Chinese medicine injections Taking the daily dosage of inpatients as an example, the price of traditional Chinese medicine injection is 2-3 times higher than that of other conventional dosage forms Pharmaceutical companies, doctors and hospitals can all benefit from this, which has opened a green light for the promotion and use of traditional Chinese medicine injection "