The Beijing News reporter counted the announcements issued by the State Food and Drug Administration. Since this year, 28 kinds of drugs have been required to modify the instructions, including some traditional Chinese medicine injections, large varieties of Chinese patent medicines, such as Pudilan anti-inflammatory solution, Bupleurum injection, Acanthopanax senticosus injection, etc. Among them, there are 19 drugs whose instructions have been revised, involving children and adolescents of different ages.
Traditional Chinese medicine injection is the focus
According to the statistics of the Beijing News reporter, of the 28 drugs whose instructions were revised this year, 10 were traditional Chinese medicine injections, of which 8 were banned/restricted or given risk warnings in the scope of children's drug use, including Chaihu injection, Shuanghuanglian injection, Qingkailing injection, Shenmai injection, Acanthopanax senticosus injection, etc.
Traditional Chinese medicine injection, as a unique drug category in China, played a very good role in the past years when there was a shortage of medicine, but most of the varieties were approved before 1985, and the clinical effectiveness data and safety data were seriously insufficient. In recent years, adverse reaction accidents have occurred frequently, causing patients to worry about the safety of traditional Chinese medicine injections.
The Beijing News reporter inquired about the information and found that among the traditional Chinese medicine injections that were required to modify the drug instructions this time, several varieties had had serious adverse reactions and fatal events. For example, the adverse reactions caused by Shuanghuanglian injection were the most prominent in 2009: three patients in Anhui, Yunnan and Jiangsu provinces died of serious adverse reactions after injecting Shuanghuanglian injection produced by Heilongjiang Duoduo Pharmaceutical. In October 2008, 6 patients in Yunnan Province experienced serious adverse reactions when using Wanda Acanthopanax senticosus injection, and 3 died.
According to the 2017 National ADR Monitoring Annual Report, among the 1.429 million ADR reports, according to the statistics of drug administration routes, intravenous administration accounted for more than 84% of the ADR reports of traditional Chinese medicine. Among the drug formulations involved in adverse drug reactions for children, 83.5% were injections.
Traditional Chinese medicine injection has been focused on, and the policy has been tightened, which has hit the market very hard. After the highly concerned "star drug for children's fever" Chaihu injection was required to be banned for children, the market also faced an impact. The Beijing News reporter found that there are 77 approval numbers of Chaihu injection in China, belonging to 75 enterprises respectively, including well-known enterprises such as Sinopharm Group, Yunnan Baiyao, and Shijiazhuang Pharmaceutical Group, as well as enterprises such as Henan Kanghua Pharmaceutical and Henan Runhong Pharmaceutical, which account for a large proportion of production and sales.
According to the data from Mi Nei Wang, the overall market scale of Chaihu injection in 2017 was 36.82 million yuan. The top three enterprises in terms of market share include Shiyao Yinhu Pharmaceutical (27.39%), Henan Fusen Pharmaceutical (14.03%) and Furen Pharmaceutical Group (9.36%). Among them, the contribution rate of Chaihu injection to the sales of Chinese patent medicines of Shiyao Yinhu Pharmaceutical in 2017 was 3.24%.
The reporter of the Beijing News sorted out 28 drugs that had been required to modify the instructions this year, and made an inventory of the contents related to children for your reference.
1. Chaihu injection: forbidden for children
Indications: It is used to treat fever of cold, influenza and malaria.
Revised content: "Prohibited for children" must be indicated in the [taboo] item.
2. Acanthopanax senticosus injection: forbidden for children
Indications: for transient ischemic attack caused by liver and kidney insufficiency, cerebral arteriosclerosis, cerebral thrombosis, cerebral embolism, etc. It is also used for coronary heart disease, angina pectoris with neurasthenia and climacteric syndrome.
Revised content: "Prohibited for pregnant women and children" is added to the [taboo] item
3. Shuanghuanglian injection: forbidden for children under 4 years old
Indications: It is used for fever, cough and sore throat caused by exogenous wind heat.
Revised content: forbidden for children aged 4 and below and pregnant women.
4. Shenmai injection: forbidden for newborns and infants
Indications: It is used to treat shock, coronary heart disease, viral myocarditis, chronic cor pulmonale, and granulocytopenia of the type of deficiency of both qi and yin.
Modification content: The [taboo] item should include: "Prohibited for newborns and infants", "Prohibited for pregnant women and breast-feeding women". The [Precautions] item should include: patients with serious heart disease, patients with abnormal liver and kidney functions, the elderly, children and other special groups, as well as patients who use this product for the first time should use it cautiously. If it is really necessary to use, clinical medication monitoring should be strengthened.
5. Qingkailing injection: forbidden for newborns and infants
Indications: It is mainly used to treat patients with high fever, restlessness, sore throat, red tongue, yellow fur, and pulse count caused by wind heat and toxin, and fire toxin; Upper respiratory tract infection, viral cold, acute suppurative tonsillitis, acute pharyngitis, acute tracheitis, high fever and other diseases belong to the above syndromes.
Modification content: The [contraindication] item should include the prohibition for newborns, infants and pregnant women.
6. Drugs containing codeine cold medicine: forbidden for children under 18 years old
Indications: severe dry cough and irritating cough caused by various reasons, especially for severe dry cough with chest pain. It can be used for moderate pain analgesia. It is an auxiliary drug for local anesthesia or general anesthesia and has sedative effect.
Revised content: The relevant content in [Contraindications] and [Children's Drug Use] is revised to "Prohibited for Children under 18".
7. Pidotimod preparation: forbidden for children under 3 years old
Indications: It is used for auxiliary treatment of chronic or recurrent respiratory tract infection and urinary tract infection
Revised content: [Drug use for children] and [contraindication] are newly added for children under 3 years old.
8. Mint Huoluo Cream: forbidden for children under two years old
Indications: Mainly used for muscle fatigue, muscle aches and pains, bruises and pains, rheumatism and bone pains, travel sickness and waves, colds and headaches, mosquito bites.
Revised content: Children under two years old and pregnant women are forbidden.
9. Haizhu wheezing tablet: forbidden for newborns and premature infants
Indications: for bronchial asthma and chronic tracheitis.
Revised content: The warnings and [taboos] should include the prohibition for pregnant women and lactating women. Prohibited for newborns and premature infants.
10。 Xuesaitong injection: forbidden for children
Indications: for apoplectic hemiplegia, blood stasis blocking collaterals; Arterial atherosclerotic thrombotic cerebral infarction, cerebral embolism, central retinal vein occlusion with congestion syndrome.
Content to be revised: the [taboo] item should be added: forbidden for children.
11. Xueshuantong injection: forbidden for children
Indications: for central retinal vein occlusion, sequelae of cerebrovascular disease, internal eye disease, anterior chamber hemorrhage, etc.
Content to be revised: the [taboo] item should be added: forbidden for children.
12. Lysine acetylsalicylate for injection: forbidden for infants under 3 months old and cautious for infants under 16 years old
Indications: Not suitable for the treatment of fever and moderate pain after oral administration.
Revised content: [Children's medication] is revised to be used with caution for children under 16 years of age, and forbidden for infants under 3 months of age.
13. Amiodarone hydrochloride injection: the safety of this product for children is not clear
Indications: It is used to treat serious arrhythmia when oral administration is not suitable.
Revised content: [Children's drug use] The revised requirements are changed to: the safety and effectiveness of amiodarone hydrochloride in children have not been established.
14. Gastrodin injection: children should use it with caution
Indications: It is used for neurasthenia, neurasthenic syndrome syndrome management, nervous headache and other diseases (such as migraine, trigeminal neuralgia, great occipital neuralgia, etc.), as well as for vertigo of traumatic brain syndrome, such as Meniere's disease, drug-induced vertigo, traumatic vertigo, sudden deafness, vestibular neuritis, vertebrobasilar artery insufficiency, etc.
Content of revision: The item [Children's medication] was revised as: no study on the effectiveness and safety of children's medication was conducted, and children should use it with caution.
15. Jingwu Capsule: Children should use it with caution
Indications: For insomnia, dreaminess, tinnitus, forgetfulness, hair loss and early whiteness.
Revised content: Item [Precautions] should include: children should use it with caution.
16. Bailemian capsule: children should use it with caution
Indications: insomnia, insomnia, etc.
Revision: Item [Precautions] should include: children should use it with caution and under the guidance of doctors.
17. Qibao Beard Pill: Children should use it carefully
Indications: for deficiency of liver and kidney, early whiteness of hair and beard, shaking of teeth, spermatorrhea and night sweat, waist acid, weak muscles and bones, weak waist and legs, thin band.
Revised content: Item [Precautions] should include: children should use it with caution.
18. Xinyuan Capsule: Children should use it with caution
Indications: for chest obstruction, heart kidney yin deficiency, heart blood stasis, symptoms of chest distress, chest tingling or colic, or chest pain penetrating the back, fixed, even worse at night, palpitations, night sweats, upset sleeplessness, waist pain, knee weakness, tinnitus and dizziness; Coronary heart disease stable exertional angina pectoris and hyperlipidemia can be seen in the above syndromes.
Revised content: Item [Precautions] should include: children should use it with caution.
19. Mianserin Hydrochloride Tablets: The safety and effectiveness of drugs for children and adolescents under 18 years of age have not yet been established
Indications: It is applicable to all types of depression patients treated with drugs and can relieve their depressive symptoms.
Content of revision: the content of [Children's medication] in the original instruction manual is revised to: the safety and effectiveness of medication for children under 18 years of age and adolescents have not been established.
Beijing News reporter Wang Kala, editor Yue Qingxiu, proofread Li Ming
