Bupleurum injection is the world\’s first type of traditional Chinese medicine injection. It is widely used as an \”antipyretic injection\” in the treatment of children\’s fever. However, on May 29, 2018, the State Food and Drug Administration issued an announcement based on the adverse reaction monitoring and safety evaluation results of the drug: requiring Bupleurum Injection to revise the instructions to clearly indicate: Contraindicated for children! Prior to this, the \”adverse reactions\”, \”taboos\” and \”precautions\” in the instructions for Bupleurum Injection were not clear. Why is it suddenly banned for children? This also starts with the adverse reactions. According to a search of public information, from 1988 to 2005, 24 relevant academic papers reported 41 real cases of adverse reactions. Among them, there are not a few cases of adverse reactions in children, most of which are allergic reactions, anaphylactic shock, syncope, etc. In addition to minor adverse reactions, deaths due to infusion and intramuscular injection have also occurred. The National Medical Products Administration stated that in order to further protect the public\’s drug safety, it has decided to add warnings to the instructions for Bupleurum Injection and revise items such as [adverse reactions], [taboos], and [precautions]. Attachment: Requirements for revision of instructions for Bupleurum Injection 1. A warning should be added, which should include: Adverse reactions of this product include anaphylactic shock. It should be used in medical institutions with rescue conditions. Users should receive anaphylactic shock rescue training. If allergic reactions or other serious adverse reactions occur after taking the medication, the medication must be stopped immediately and treated promptly. 2. The following content should be added to the [Adverse Reaction] item: Allergic reaction: skin flushing or paleness, rash, itching, dyspnea, palpitations, cyanosis, drop in blood pressure, anaphylactic shock, anaphylactoid reaction, etc. Systemic reactions: chills, chills, fever, pain, fatigue, etc. Skin and its appendages: A variety of rashes can occur, mainly urticaria and dermatitis with itching. Respiratory system: breathlessness, shortness of breath, difficulty breathing, etc. Cardiovascular system: palpitations, chest tightness, cyanosis, decreased blood pressure, etc. Neuropsychiatric system: dizziness, headache, numbness, vertigo, syncope, convulsions, confusion, etc. Digestive system: dry mouth, nausea, vomiting, abdominal pain, diarrhea, etc. Application site: pain, rash, itching, local redness, swelling and induration, etc. 3. [Contraindications] should include: 1. It is prohibited for those who are allergic to this product or the preparations containing Bupleurum and the excipients listed in the ingredients or have a history of serious adverse reactions. 2. Not allowed for children. 4. [Precautions] should include: 1. The adverse reactions of this product include anaphylactic shock. It should be used in medical institutions with rescue conditions. Users should have received anaphylactic shock rescue training. If allergic reactions or other serious symptoms occur after taking the drug, Adverse reactions must be discontinued immediately and treated promptly. 2. Use strictly in accordance with the functional indications specified in the drug instructions, and use of super-functional indications is prohibited. 3. This product is an antipyretic and superficial medicine, and should not be used by people without fever. 4. Use strictly in accordance with the recommended usage and dosage in the drug instructions, paying special attention to not exceeding the dose and not using the drug continuously for a long time. 5. Before taking medication, you should carefully inquire about the patient’s condition, medication history and allergy history. Those with a history of drug allergy or allergic constitution should use with caution. 6. People with a family history of allergies should use it with caution. 7. Improper storage of this product may affect the quality of the drug.This product should be carefully checked before use. Do not use it if it is found that the liquid has turbidity, precipitation, discoloration, crystallization and other drug properties changes, or if the bottle has leaks, cracks, etc. 8. Mixing and compatibility is strictly prohibited and caution should be exercised in combined use of medications. This product should be used alone and is not allowed to be mixed with other drugs. 9. Special groups such as the elderly, pregnant women, patients with abnormal liver and kidney function, and patients who are using traditional Chinese medicine injections for the first time should use it with caution and strengthen monitoring. 10. Strengthen medication monitoring. During the medication process, the medication reaction should be closely observed, especially in the first 30 minutes. If abnormalities are found, the medication should be stopped immediately and active treatment measures should be taken to treat the patient. What should I do if my child has a fever? When a child has a low fever, physical cooling is generally recommended; only when the body temperature exceeds 38°5, the use of antipyretics is recommended. The well-known ibuprofen (Motrin) and acetaminophen (Tylenol) are commonly used antipyretics for children and are safe as long as they are used according to the doctor\’s advice. Representative acetaminophen drugs include Tylenol, paracetamol, Biliton, and Peifuning. It is by far the most commonly used children\’s antipyretic medicine, suitable for babies over 3 months old and adults. Its fever-reducing intensity is equivalent to that of aspirin (it works quickly), but it has few side effects, slight gastrointestinal irritation, does not affect blood coagulation, and does not cause Reye\’s syndrome. It has been widely recommended and used by countries around the world. This drug is currently also recommended by the World Health Organization as the first choice drug for children with high fever. However, if this drug is used improperly, it can damage the liver. Because this drug is metabolized by the liver, the metabolites contain a very small amount of hydroxylates that are toxic to liver cells. If the baby is too young, the liver detoxification function is incomplete, so be careful as it may cause liver damage, so Be sure to read the instructions carefully before taking this medicine, or take it under the guidance of a doctor! The representative drugs of ibuprofen are Motrin and Fenbid. Ibuprofen has the advantages of less adverse reactions, mild gastrointestinal irritation, less impact on hemogram and kidney function, and its antipyretic effect is more durable. The average controlled fever reduction time is about 5 hours. For high fever above 39, ibuprofen has a better antipyretic effect than acetaminophen. It is generally used for babies over 6 months old who have a high fever that is difficult to go away. It should be used with caution for babies under 6 months old. However, the order of effects of ibuprofen is anti-inflammatory, analgesic, and antipyretic. Therefore, its primary role is to reduce inflammation rather than reduce fever. Therefore, even if the baby reaches the age of taking ibuprofen, parents should strictly calculate the dose accurately based on the baby\’s weight. What is banned this time is Bupleurum injection. Bupleurum oral liquid, oral granules and other preparations can still be used. But Mr. Xiaokang must emphasize one point: no matter what medicine, it must be used under the guidance of a doctor, especially when it comes to dosage, you must ask clearly about the specific dosage and usage. Before giving medicine to your child, be sure to read the medicine instructions carefully. It will tell you the common symptoms after taking the medicine. Babies with certain medical conditions cannot take the medicine. If you are really not sure, go to the doctor to ask for clarification. , can you give medicine to your child. Do not blindly give medicine to your baby, or increase the dose without permission!
You are Here
- Home
- Parenting knowledge
- infancy
- The Food and Drug Administration has issued an order: This type of antipyretic drug for children is prohibited. Never give it to your child again.