Anaijin various dosage forms modified supplement tablets for teenagers and children under 18 years of age
The antipyretic drug “An Nai Jin”, which was once realized, will be revised.On March 17, the State Food and Drug Administration issued a notice to amend the “Adverse Reactions” and “Precautions” in the instructions of Anaijin tablets, compound Qinghaoannai tablets, Zhongganling tablets and Zhongganling capsules., Which specifies the number of children under the age of 18.Analgin is approved in various dosage forms. Analgin is a pyrazolone antipyretic and analgesic. It was marketed earlier here. The types of preparations include oral preparations, injections, and nasal drops.Since its listing in the 20th century in the last century, An Nai has recently become the “King of Fever”.However, its highest fatal lethal damage has attracted the attention of many national drug regulatory agencies, including Australia, Norway, the United States and other nearly 30 countries, which have banned sales, evacuated the city or restricted the use of Analgin.With the development of pharmaceutical technology and the deepening of the monitoring of adverse reactions, the awareness of drug safety risks has become more comprehensive. The National Drug Supervision and Administration Department has paid close attention to the safety issues of these varieties and carried out relevant assessments and risk warnings.According to the evaluation of the State Drug Administration, Anaijin injection, Analgin chlorpromazine injection, Pediatric Analgin enema, Analin drops, Analgin nasal drops, nasal dropsThere are serious allergic reactions in children’s antipyretic emboli, severe agranulocytosis and other adverse reactions, the risks are greater than the total, and they are clinical substitute drugs and substitute drug registration certificates.Data from Minet shows that starting in 2018, the market size of Anaijin has dropped to 25.17 million, 46 per inch.18%.According to data from the State Food and Drug Administration, as of March 17 of this year, there were 1,329 relevant approvals and nearly 1,000 manufacturing companies.Among them, An Nai’s recent film approvals totaled 1,124, accounting for the largest proportion.The “survival” of Anaijin tablets must be revised to explain that the State Drug Administration believes that oral preparations such as Anaijin tablets still have some clinical value, which has led toZhongganmaoling tablets and Zhongganmaoling capsules have adopted the risk control measures of the revised manual, added safety warning information, and restricted the applicable population and the scope of indications.According to the revised requirements, some of the above-mentioned medicines are equal to young children under the age of 18.Among them, An Nai Jin tablets added warnings, suggesting that this product may cause serious adverse reactions in the blood system, such as agranulocytosis, thrombocytopenic purpura, and aplastic anemia.This product may also cause severe allergic reactions, such as severe drug eruption, anaphylactic shock, etc.For the appropriate dosage, delete “appropriate dosage for children” and add “should start from the lowest effective dosage”.In addition to adolescents and children, women in the third trimester also supplement the drug.Indications, adverse reactions, precautions and other supplementary amendments.Note that “this product is generally not the first choice” should be added, only for short-term use when the condition is critical and there is no other effective drug treatment.Judging from the revised adverse reactions, Analgin causes skin damage, disease damage, systemic damage, blood system damage, urine system damage, and other damage. There have been reports of fulminant purpura and death.Editor Yue Qingxiu proofreading Liu Yue