Food and Drug Administration Reminds Attention to Anaphylactic Shock Caused by Cefathiamidine for Injection and Drug Risk for Children


Release time:

2015-12-12

The State Food and Drug Administration recently issued the 69th issue of "Adverse Drug Reaction Information Bulletin", reminding attention to the anaphylactic shock caused by cefathiamidine for injection and the risk of drug use for children. Cefathiamidine for injection is a systemic anti-infective drug independently developed in China. Its mechanism of action is similar to that of other cephalosporins, and it has bactericidal effect by inhibiting the biosynthesis of bacterial cell wall. Indications for sensitive bacteria caused by respiratory system, hepatobiliary system, facial features, urinary tract infection and endocarditis, sepsis. From July 1, 2014 to June 30, 2015, 5802 adverse drug reaction/event reports caused by cefathiamidine for injection were received in the national adverse drug reaction monitoring database, mainly involving skin and its accessories damage, systemic damage, gastrointestinal system damage, etc. Serious adverse reactions/events were reported in 277 cases, mainly manifested as anaphylactic shock, anaphylactoid reactions, dyspnea, chills, high fever, palpitation, chest tightness, rash, pruritus, etc. Among them, the adverse reactions of anaphylactic shock were more prominent, accounting for 17.0% of the serious cases reported. In the serious report, 133 cases did not use the dosage according to the instructions, including single overdose, daily overdose administration, not divided administration, etc. There are more reports of cefathiamidine for injection in children, including 1677 cases of adverse reactions/events of cefathiamidine for injection in children under 6 years old, accounting for 28.9 of the total reports of this variety. 53.9 per cent of pediatric patients were administered once a day, with 2-4 doses not in accordance with the drug instructions. According to the analysis of monitoring data, the State Food and Drug Administration recommends the following: 1. Cefathiamidine for injection is prone to severe allergic reactions, such as anaphylactic shock. Medical personnel should ask the patient's allergic history in detail before using this product. Allergy to the ingredients contained in this product is prohibited, and those with allergies should be used with caution. Patients should be closely observed during the administration period. Once allergic symptoms occur, the drug should be stopped immediately and treated. 2. Medical staff should use this product in strict accordance with the drug instructions, and use the recommend daily dose in batches, especially when using drugs for children, to avoid excessive single dose or overdose of the total daily dose. 3. Production enterprises shall timely revise and improve the relevant contents of drug instructions, strengthen the monitoring of adverse drug reactions after listing, do a good job in publicity and training of safe drug use, and guide clinical rational drug use. For more information, please visit the website of the State Food and Drug Administration (http://www.cfda.gov.cn) or the website of the National Adverse Drug Reaction Monitoring Center (http://www.cdr-adr.org.cn/). Tips: 1. cefathiamidine is mainly used to treat what disease? Cefathiamidine is a systemic anti-infective drug independently developed in China, which belongs to the first generation of cephalosporins. Its mechanism of action is similar to other cephalosporins, and it can achieve bactericidal effect by inhibiting the biosynthesis of bacterial cell wall. Indications for sensitive bacteria caused by respiratory system, hepatobiliary system, facial features, urinary tract infection and endocarditis, sepsis. What are the adverse reactions of Cefathiamidine for 2. injection? The clinical manifestations of adverse reactions of cefathiamidine for injection mainly involve skin and its appendages damage, systemic damage, gastrointestinal system damage and respiratory system damage, including rash, pruritus, urticaria, maculopapular rash, dyspnea, chills, palpitation, high fever, chest tightness, vomiting, diarrhea, allergic reaction, anaphylactic shock and so on. Severe allergic reactions caused by cefathiamidine for injection include anaphylactic shock, anaphylactic reactions, dyspnea, chills, high fever, palpitation, chest tightness, and rash. What are the risks of medication for 3. children? The proportion of adverse reactions reported in children after the use of cefathiamidine was higher, and the cases of adverse drug reactions reported in children under 6 years old accounted for 28.5 of the total reports. Overdose use is common in children, with 57.9 per cent of children taking the drug once a day and not divided into doses according to the instructions. The main clinical manifestations of severe adverse reactions in children were rash, pruritus, chills, high fever, anaphylactic shock, anaphylactic reaction, cyanosis, dyspnea and so on. What are the precautions for the 4. use of cefathiamidine for injection? 1. This drug can cause anaphylactic shock and should be used in medical institutions with rescue conditions. Allergic reactions or other serious adverse reactions after medication must be stopped immediately and treated in time. 2. Patients with a history of gastrointestinal diseases, especially ulcerative colitis, Crohn's disease or pseudomembranous colitis, should be used with caution. The application of this product in patients with renal dysfunction must be appropriately reduced. 3. This product should be ready to use, should not be placed for a long time. 4. This product should be used alone and should not be mixed with other drugs in the same container.