The safety of ethyl-containing starch is warned about the impact of the drugs

February 26, the state Food and Drug Administration issued a warning to pay attention to the drug containing hydroxyethyl starch in severe sepsis patients with kidney injury and mortality increased risk. The daily economic news reporter was informed that before that, the European Drug Administration (EMA) had made it clear that the Drug Risk Assessment Committee (PRAC) recommended that hydroxyethyl starch be returned to the city. Xu Lingni, a researcher in CIC's pharmaceutical industry, sees the two companies will suffer as a result of the market share of China Resources dual-core and the Cologne pharmaceutical industry as a whole in the market of hydroxyethyl starch. To the specific population risk in layman's parlance, containing hydroxyethyl starch drugs for blood volume supplements, mainly for the prevention and treatment of various causes of low blood volume, including hemorrhagic, burns and surgical shock, such as thrombotic occlusive disease. February 26, the reporter was informed that the State administration of food and drug supervision of its safety issues again analyzed and evaluated. It is concluded that the risk of elevated mortality, kidney damage and excessive bleeding in patients with hydroxyethyl starch in specific health conditions, especially in patients with severe sepsis, is increased. The state Food and Drug Administration said that the risks mentioned in foreign literature have been monitored in China. A number of foreign studies and meta-analysis suggest that the risk of death and/or kidney replacement therapy increases with the use of hydroxyethyl starch in patients with severe sepsis compared to crystalline liquid. In the report of adverse reactions of hydroxyethyl starch drugs collected in China, the main reasons for the use of surgery or after surgery to fill the volume of congestion, blood loss of blood flow, cerebral infarction, trauma, burns and so on, 1 cases (0.03%) of the use of drugs for septic shock, no obvious risk of using. In order to promote clinical safety and rational use of hydroxyethyl starch drugs, the general administration will be the first unified revision of hydroxyethyl starch specifications. In the field of the Basic Medicine Catalogue (2012 edition) of China, the hydroxyethyl starch 40 and Dextran are two categories of blood volume expansion agents, which are widely used in clinic. Fresenius, Cologne, double cranes are based on this variety as the company's key product layout development. From the industry point of view, the general administration of the "reminder" or will be in the field of large infusion leading enterprises have an impact. As an important variety in domestic infusion, hydroxyethyl starch has more than 1.5 billion yuan in the conservative value. According to the relevant statistics released February 26 by the General administration, we are currently selling 4 molecular weight products including hydroxyethyl starch 20 sodium chloride injection, hydroxyethyl starch 40 sodium chloride injection, hydroxyethyl starch 130/0.4 sodium chloride injection and hydroxyethyl starch 200/0.5 sodium chloride injection. and Hydroxyethyl starch 130/0.4 electrolyte injection. Xu Lingni said that the domestic enterprises involved are mainly huarun double cranes (market, interrogation) and the branch-LUN pharmaceutical industry. China Resources Double Crane 2012 large infusion sales income of 2.44 billion yuan, of which surplus source (hydroxyethyl starch and sodium chloride injection) sales scale of about 100 million yuan, accounting for the total income of large infusion of about 4%. The Cologne pharmaceutical industry in 2012In the annual report, called Hydroxyethyl starch sodium lactate ringer injection industrialization, has been the development and Reform Commission general name of chemical drugs developed project. Currently marketed in China, hydroxyethyl starch drugs In addition to the general administration of the above-mentioned injection products, but also including hydroxyethyl starch 130/0.4 electrolyte injection. From an industry point of view, the move will have an impact on the enterprises involved in the production of the above products. "Because of hydroxyethyl starch drugs in the entire market with CR dual-core and the market share of the cologne industry is larger, so the two companies will suffer severe impact." Xu Lingni said to the daily economic news reporter. In the past 2013 years, the responsible person in charge of the drug industry in the "21st Century Economic Report" interview Blunt, the company related products a total of two, its own profit is very thin, the proportion of the overall sales of small, of which the profit contribution accounted for is small, and 2012 two products overall sales are less than 10 million and Cologne for product safety monitoring has been ongoing, the above-mentioned responsible person in the media interview suggested that this matter also need to further discussion and research in China's relevant academic circles, should not easily give up this clinical commonly used products.