Another cold medicine is required to modify the instruction manual! Children should use it with caution, and infants should not use it!

[policies and regulations of chinapharma.com] on January 31, the State Food and Drug Administration issued the announcement on Revising the instructions of lysine for injection (No 11, 2018) According to the announcement, in order to further protect the public's drug safety based on the evaluation results of adverse drug reactions, it was decided to add warning words to the instruction manual of lysine for injection, and revise the [indications], [adverse reactions], [precautions], [children's medication] and other items According to the requirements of the State Administration of food and drug administration, all manufacturers of lysine for injection shall submit supplementary application for the revision of the manual in accordance with the requirements of the revision of the manual, and report to the provincial food and Drug Administration for filing before March 31, 2018 Replace all drug instructions and labels that have been delivered within 6 months after the supplementary application is filed According to the relevant instructions, the indications of lysine for injection are to relieve fever, mild and moderate pain, fever caused by various reasons, and platelet aggregation inhibition Many parents have questions about whether children can take lysine when they have cold and fever symptoms, since it can be used for fever and mild to moderate pain? Experts said that children under the age of 12 should use drugs with caution; infants under 3 months should not use drugs Because children are in the period of growth and development, many organs have not developed well, the detoxification and excretion functions of liver and kidney, and the function of blood-brain barrier are not perfect, and the metabolism, excretion and tolerance of many drugs are easily caused by improper use However, as early as a few years ago, there have been many cases of Rui's syndrome caused by injection of lysine, such as infant death, children's allergies or limb weakness Most of these tragedies are caused by parents and medical staff who do not know the drug application object In this regard, the General Administration of the people's Republic of China has made a key reminder of lysine to remind parents and medical staff In this announcement, we can see that the General Administration explicitly requires the drug's instruction manual to add a warning: "this product can cause anaphylactic shock, severe skin damage and other adverse reactions..." The General Administration also requires that the instruction manual of such drugs [children's medication] be revised as follows: children under the age of 16 should use them with caution, and infants under three months should not use them It may cause Reynold's syndrome in children, see adverse reactions This also means that all pharmaceutical manufacturers that have already delivered the drug will replace the instruction manual and label In CFDA search, we found that there are 55 approvals for lysine for injection, involving 22 pharmaceutical companies The details are as follows: in recent years, there are countless tragic cases caused by improper use of drugs in infants and young children, which make people feel distressed and flustered Parents and medical staff must pay attention to relevant drug knowledge It is understood that aspirin should also be used with caution, in addition to lysine, which should not be used in 3-month-old infants Children are the future of the motherland and the hope of the whole family They need the protection and care of the whole society Appendix: the revised requirements for instructions of lysine for injection I warning words added: "this product can cause anaphylactic shock, severe skin damage and other adverse reactions During the course of medication, close monitoring should be carried out If there are symptoms or signs such as rash, pruritus, dyspnea, asthma, laryngeal edema, and blood pressure drop, the medication should be stopped immediately and treated in time " 2 The indication was changed from "for fever, mild and moderate pain" to "not suitable for the treatment of fever and moderate pain by oral administration" 3 The "anaphylaxis" and "Reynold's syndrome" in the item of adverse reactions [adverse reactions] are revised as follows: 1 Anaphylaxis: a few patients have allergic reactions such as skin rash, urticaria, asthma, angioneuroedema or mucous membrane hyperemia after taking medicine, and anaphylactic shock may occur in severe patients Among them, asthma is more common, and it occurs in the middle-aged people over 30 years old They have dyspnea and wheeze after taking medicine for several minutes It is called "aspirin asthma", which can be life-threatening in severe cases Serious skin lesions have been reported including bullous rash, toxic epidermal necrolysis and exfoliative dermatitis 2 Raynaud's syndrome: children under 16 years old may have Raynaud's syndrome when using this product Children and adolescents with varicella or flu like symptoms within 1-2 weeks should not use this product If the crowd suddenly has severe headache, frequent vomiting and restlessness after using this product, they should be alert to Reynold's syndrome Although this kind of situation is rare, but the nervous system symptom progresses rapidly, may endanger the life IV precautions [precautions] add the following contents: 1 The drug can cause anaphylactic shock The doctor should ask the patient about the history of drug allergy, and monitor closely during the course of medication If there are symptoms and signs such as rash, pruritus, dyspnea, laryngeal edema, and blood pressure drop, the doctor should stop the medication immediately and treat in time 2 The drug can cause serious skin damage, including bullous rash, toxic epidermal necrolysis, exfoliative dermatitis, etc If the patient has skin rash, pruritus and other adverse reactions, the drug should be stopped immediately and the patient should be treated in time V children's medication [children's medication] is revised as: children under 16 years old should use it with caution, and infants under 3 months old should not use it It may cause Reynold's syndrome in children, see adverse reactions (Note: if other contents of the manual are inconsistent with the above revision requirements, they shall be revised together )