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    Home > Medical News > Latest Medical News > Children cannot "feed" cold medicines randomly, 14 kinds of medicines for children were named by the Drug Administration

    Children cannot "feed" cold medicines randomly, 14 kinds of medicines for children were named by the Drug Administration

    • Last Update: 2021-07-08
    • Source: Internet
    • Author: User
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    Reporter | Yuan Yiming

    Edit | Xie Xin


    On April 23, the official website of the State Food and Drug Administration announced the "Announcement on Revising the Drug Inserts of 14 Varieties of Paracetamol and Mami Oral Solution" (hereinafter referred to as the "Announcement"), restricting and warning on the use of several cold medicines for children

    .


    The "Announcement" shows that the 14 medicines that need to be revised this time are paracetamol Mami oral solution, paracetamol Mami syrup, pediatric paracetamol granules, paracetamol and pseudoephedrine chewable tablets, pediatric compound paracetamol tablets, and children Aminocahuangmin Granules, Aminojinjinmin Granules, Aminocayumin Solution, Children's Compound Paracetamol and Renin Tablets, Aminocahuangmin Oral Solution, Paracetamol and Pseudoephedrine Dispersible Tablets (Ⅲ), Pediatric Paracetamol and Namin Tablets, Pediatric Paracetamol Huang Namin Tablets, Pediatric Paracetamol Huang Namin Granules

    .


    In accordance with the requirements of the State Food and Drug Administration, the 14 drugs mentioned above need to be added with warnings and precautions, "Parents or guardians are not recommended to use this product for infants under 2 years old, and should be used under the guidance of a physician or pharmacist"; In the item column, “should be used strictly in accordance with the usage and dosage of the drug insert to avoid overdose”, and “cannot take other anti-cold medicines with similar ingredients to this product at the same time” to “should avoid combined use containing the same or similar Anti-cold medicine with active ingredients"

    .


    It is worth noting that the above 14 kinds of products all contain acetaminophen

    .
    Acetaminophen is a metabolite of phenacetin in the body, which can reduce the synthesis and release of prostaglandins PGE1, bradykinin and histamine by inhibiting the hypothalamic body temperature regulation central prostaglandin synthase

    .
    Acetaminophen is indicated for colds and fever, arthralgia, neuralgia and migraine, cancer pain and postoperative pain relief.
    It is also an alternative medicine for patients who are allergic to, intolerant or not suitable for aspirin

    .


    Acetaminophen is available as a prescription drug and an over-the-counter drug

    .
    It is generally believed that it is safe to use acetaminophen at a dose not exceeding the recommended dose, and medicines containing acetaminophen have become a common anti-fever and cold medicine in many people's homes

    .
    However, in fact, the harm of acetaminophen is not low if it is used incorrectly

    .


    On October 27, 2017, the list of carcinogens published by the International Agency for Research on Cancer of the World Health Organization was preliminarily compiled and referenced.
    Acetaminophen was included in the list of 3 types of carcinogens (the carcinogenicity is not clear, the possibility is relatively low)

    .


    On March 3, 2020, the National Medical Products Administration issued the "Announcement on Revising the Instructions for Paracetamol Normal Release and Sustained Release Preparations

    .
    " It requires that the instructions of acetaminophen regular-release and sustained-release preparations should be marked "Excessive use of acetaminophen can cause severe liver damage; long-term medication should regularly check liver biochemical indicators; if abnormal or abnormal liver biochemical indicators are found during medication When there is general fatigue, loss of appetite, oiliness, nausea, abdominal distension and pain, yellow urine, yellow eyes, yellow skin and other clinical manifestations that may be related to liver damage, the drug should be stopped immediately and medical treatment should be taken, and acetaminophen should be taken orally The maximum amount per day does not exceed 2g"

    .


    The "Announcement" also requires that the instructions of the above 14 products must be named "Avoid overdose", which also means to prevent children from causing damage to the body due to overdose of acetaminophen

    .


    In addition to the misunderstanding of acetaminophen, there is still a problem with the vague concept of "compound" in the use of children's cold medicine

    .
    The 14 products named this time are all compound cold medicines, which are compound preparations containing two or more pharmaceutical ingredients in one medicine

    .
    In this case, if the parents take two drugs containing acetaminophen at the same time for their children, the dose will be very easy to overdose

    .


    This is also the reason why the "Announcement" requires the instructions to specify that the above 14 products "should avoid the combined use of anti-cold medicines containing the same or similar active ingredients"

    .


    The "Announcement" requires that the marketing authorization holders of the above 14 products should file for the record before July 21, 2021 and replace all the drug inserts and labels that have been shipped out of the factory within 9 months after the record

    .
    Jiemian reporters found on the official website of the State Food and Drug Administration that the above-mentioned drugs involved 412 document numbers

    .


    According to data from Minai.
    com, the size of China's children's medicine market reached 65.
    197 billion yuan in 2016, and it is expected to exceed 70 billion yuan in 2017, of which cough and cold medicines account for more than 40%

    .
    In contrast, pediatric cold and cough medicines are mostly compound preparations.
    In 2017, of the 32 pediatric cold and cough medicines in public hospitals in major cities in China, compound preparations accounted for more than 70%

    .


    According to data from Mi Nei.
    com, in 2017, the amount of pediatric paracetamol in public hospitals in major cities in China was 22.
    55 million yuan, of which the top three manufacturers were Angel Yeast (85.
    76%), Hunan Hengwei (10.
    32%), and Xinjiang Nanjing Tongrentang Health (3.
    15%), and many other manufacturers account for 0.
    77%

    .

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