Ban! Children's fever-reducing drug used for 70 years suddenly declared by FDA: banned for children

Another common drug for children, banned.

Last night at 12 o'clock, the State Drug Administration (CFDA) issued a bulletin, requiring Chaihu injection instructions to increase the warning language, and [adverse reactions] [contraindications] [precautions] and other items to be revised.

Photo credit: State Drug Administration

http://cnda.cfda.gov.cn/WS04/CL2050/228214.html

In the newly released "Requirements for Revision of Instructions for Chaihu Injection", the CFDA clearly states that in the [Contraindication] item, it must be indicated that"Prohibited for Children。

Photo credit: State Drug Administration

Before that, Chai Hu injection was commonly used for "fever treatment for influenza" and was more commonly used as a fever-reducing injection to reduce fever in children in clinical medicine.

Less than an hour after the news was sent out, the topic had already made it to the Weibo hit list.



Parents who hadn't had time to fall asleep were jolted into leaving messages of fear and anger: their own children, who had been injected with this drug just a short time ago!

How could such a common pediatric drug suddenly be banned?

The reason for this goes back to the adverse reactions.

This CFDA announcement, in addition to stating "contraindicated in children," also clarifies the adverse effects of Chai Hu injection.

Photo credit: State Drug Administration

Before that, on the instruction manual of Chaihu injection, regarding "adverse reactions" and "contraindications", only four words were written - "not yet clear".

Image Source: Internet

Chaihu injection has been used clinically for more than 70 years.

In the middle of the war, when medical resources were scarce, the first "Chai Hu Injection" was born in the crude pharmaceutical factory of the Eighth Route Army. At that time, it was named "Cascade Cheng Lil", and it was mainly used to treat "influenza, returning fever, puerperal fever, fever during the development of tuberculosis", and it could also cope with "stubborn malaria".

In December 1954, this drug was re-assessed and officially named "Chai Hu Injection" and put into mass production, which was brilliant for a while.

However, with widespread clinical use, cases of adverse reactions to Chai Hu injection have ensued.

From the open source, from 1988 to 2005, there were 24 academic papers reporting 41 cases of real adverse reactions.

Among them, there are not a few cases of adverse reactions in children, most of which are manifested as allergic reactions, anaphylactic shock and syncope.

In addition to non-serious adverse reactions, deaths from infusion and intramuscular administration of medications have occurred.

A 6-year-old child with fever due to upper respiratory tract infection and intramuscular injection of Chai Hu injection with widespread diffuse edematous erythema and large epidermal necrosis with large blisters of varying sizes was diagnosed as herpetic epidermolysis bullosa drug rash, and died of resuscitation after 1 week of hospitalization.

An 11-year-old girl, after 14 mL of Chai Hu injection, bleeding spots appeared on her face, hands and feet, and was left untreated, and she developed pain, irritability, flaccid paralysis, and urinary and fecal incontinence 2 hours later. She was diagnosed with anaphylactic shock and acute renal failure, and died of failure to rescue.

It is because of the frequency of such accidents, there is the State Drug Administration of this manual revision.

For the sake of the health of millions of children, please keep the five words "Chai Hu Injection" in your mind and forward this message to the parents around you as you wish.

bibliography

Zhang Xiaoxia, The birth of the first Chinese medicine injection, Chaihu injection, China Traditional Chinese Medicine Newspaper

Announcement of the State Drug Administration on the Revision of the Instruction Manual of Chaihu Injection (No. 26 of 2018)

Zhang Lijuan, Chaihu injection intramuscular injection caused serious adverse reactions in 3 cases, Medical Information, 2010.1

Adverse effects of Chaihu injection Lin, B. M., 362321

Yesterday, Chaihu injection dominated the screen, so how much do you know about the first Chinese medicine injection in the history of the world's pharmaceutical industry? Today we will take a peek at the history of "Chaihu injection".

In the middle of the War of Resistance, the Eighth Route Army was facing a double blockade from the Japanese Army and General Chang Kai-shen, and there was a great shortage of medicines and materials, so the Eighth Route Army actively carried out the cause of self-help in the production of medicines and health care, and set up the Sanitary Material Factory of the Field Health Department (later named Lihua Pharmaceutical Factory, now Wuhan Yuanda Pharmaceutical Group Co., Ltd.), and Soong Ching-ling donated 5,000 yangyang for the establishment of the factory and the purchase of equipments. Chairman Mao once inscribed, "Pharmaceutical treatment of wounds, not afraid of blockade, is one of the conditions for victory over the enemy". These material factories and pharmaceutical factories produced some sanitary materials and supplies such as gauze, cotton wool, bandages and emergency kits using local methods, and also produced simple medicines and Chinese medicine preparations.

In 1939, many soldiers of the Eighth Route Army fighting in the Taihang Mountains suffered from influenza, malaria, etc. Because of the tight blockade, it was difficult to bring in medicines, and there was an abnormal lack of medicines. Qian Xinzhong, then Minister of Health of the 129th Division, called on the medical staff to collect Chaihu in the mountains and boil it into a soup for the sick, "the effect is actually very good". For the convenience of carrying, the Eighth Route Army Pharmaceutical Factory will be made of Chaihu Chaihu cream, but the "clinical effect is not good", and then Qian Xinzhong proposed the distillation of Chaihu Chaihu extract made of injections. The first Chinese medicine injection "Chaihu injection" was born in the Eighth Route Army's simple pharmaceutical factory. This is the history of Chinese medicine, the first intramuscular injection of Chinese medicine, named "Cascade Chenglier". Later, this injection was officially named "Chaihu injection". At that time, it was used to "treat influenza, return fever, puerperal fever, fever during the development of tuberculosis, and to deal with persistent malaria". In May 1943, Xinhua Daily (Taihang edition) published a report entitled "New Contribution to the Medical Profession - Lihua Pharmaceutical Factory Invented Chaihu Injection", which was called a major initiative of the blockade, and became the earliest historical record in China about the success of the western system of traditional Chinese medicine.

Although Chaihu injection has been used in China for more than 70 years, with the strengthening of adverse drug reaction monitoring in recent years, the state has begun to revise the instruction manuals of several Chinese medicine injections. The Annual Report on National Adverse Drug Reaction Monitoring (2017) shows that the proportion of injections and oral preparations in the 2017 TCM ADR/event reports was 54.6% and 37.6%, respectively; and in terms of the routes of administration involved in the serious reports, intravenous administration accounted for a relatively high proportion. Prior to this, the "adverse reactions", "contraindications" and "precautions" of many Chinese medicine injections, including Chaihu injection, were mostly labeled as "not yet clear". Not yet clear".

It is based on the above data, on May 29, 2018, the State Drug Administration issued an announcement that, based on the results of the monitoring of adverse drug reactions and safety evaluation, in order to further protect the safety of public medication, the decision was made to revise the instruction manual of Chaihu injection. The revisions include the addition of warnings and the revision of "adverse reactions", "contraindications", "precautions" and other items. After the revision, the warning of the drug suggests that "adverse reactions include anaphylactic shock", and the contraindications are clarified as "prohibited for children".

There are 8 types of "adverse reactions" for Chaihu Injection, including allergic reactions, systemic reactions, and adverse reactions to the skin and its accessories, respiratory system, cardiovascular system, neuropsychiatric system, digestive system, and the site of application. Allergic reactions and pyrogenic reactions caused by Chinese medicine injections are more common.

Pyrogens belong to bacterial metabolites, and if pyrogens are present in the injection solution, pyrogenic reactions will occur during infusion. Because the raw materials of Chinese medicine injection are various herbs from complex sources, and Chinese medicine injection does not require purification to a single component, Chinese medicine injection is prone to pyrogens, which is an inherent defect of Chinese medicine injection. Children are more prone to allergic reactions when using Chaihu injection.

Clinical use of Chaihu injection as a "fever-reducing injection" itself is also a problem, with the development of the pharmaceutical industry, fever-reducing drugs, fever-reducing patches have been very developed, so there is no need to use the complex composition of the traditional Chinese medicine injections for the treatment of children with fever.

In fact, it's not just the injections that are controversial, but Chai Hu itself, and in addition to the injections, there are common dosage forms such as Xiao Chai Hu granules.

In 1972, Tsumura Juntendo Pharmaceutical Co., Ltd. of Japan was the first to produce Xiaochaihu Tang Granules. In the same year, Prof. Shigeru Aritsu published the research report of "Tsumura Xiao Chaihu Tang Granules have therapeutic effect on chronic hepatitis", and for a while, the Japanese people were convinced and began to use Xiao Chaihu Tang Granules for the treatment of liver diseases, and Chaihu began to go to the peak of its life in Japan. In just a few years, by virtue of the resounding name of Master Shiba, Japan's Tsumura Juntendo Pharmaceutical Co., Ltd. amassed wealth at light speed, and became a pharmaceutical company that attracted attention in Japan and even in the world. Unfortunately, the good times didn't last long, and in the early 1990s, the Japanese media began to break the news about the side effects of Chai Hu. 1991, the then Japanese Ministry of Health and Welfare (equivalent to China's Food and Drug Administration) announced a notice that Xiao Chai Hu Tang Granules could lead to interstitial pneumonitis and reminded physicians and pharmacists to be careful with its use. 1994-1999, due to the large doses of long-term consumption of Xiao Chai Hu Tang Granules, resulting in 188 cases of interstitial pneumonitis, of which 22 died. In 1997, Tsumura Juntendo Pharmaceutical Co., Ltd. declared bankruptcy, and in 2000, President Akira Tsumura was sentenced to three years in prison for this crime. Nowadays, the Japanese people seldom use Xiao Chai Hu Tang granules because they are afraid of the well rope for ten years.

In the 1990s, Guangzhou Baiyunshan Guanghua Pharmaceutical Co., Ltd. took the lead in making Xiao Chaihu Granules, the most popular Xiao Chaihu in the domestic market croaked. 2000, the Chinese Pharmacopoeia formally included Xiao Chaihu Granules, which gained official recognition and became a veritable national medicine.

side effects of faggots The Japanese have already led the way for the benefit of the people of the planet at large. Should we still go forward and follow suit? We can all think for ourselves.

(summer nights listening to the rain)

The hottest thing in healthcare today would have to be "State Drug Administration issued a letter requiring Chai Hu injection to be banned in children", the bombshell went off.

Chaihu injection, the world's first variety of Chinese medicine injection, has been in clinical use for more than 70 years, why is it proposed at this time that it should be banned for use in children? The reason is simple: safety.

The role of Chaihu injection, mainly for the treatment of fever fever, as a "fever-reducing injection" in the treatment of fever in children in common use. Previously, the adverse reactions, contraindications and precautions of Chaihu injection were not clear (in fact, they were not clear).Not only Chaihu injection, which is a common problem of most Chinese medicine injections or oral preparations, most of them lack pharmacological experiments or clinical trials of safety observation(See Section 2.1.2.).

The SFDA announcement also requires that the new specification for Chai Hu injection should state that adverse reactions to the product include anaphylaxis.

According to an announcement from the FDA.China to study and launch reevaluation of traditional Chinese medicine injections in 2018. Chinese medicine injections do have the disadvantage of many adverse reactions, some of them serious as well, and the instructions are mostly written yet unclear.

According to the announcement of the FDA, this has attracted the attention of the state, and the re-evaluation of traditional Chinese medicine injections is very necessary. This time, children are explicitly prohibited from using Chaihu injection, which is alsoBased on the results of adverse reaction monitoring and safety evaluationof this, it is an improvement and a hope.

in my opinionAdverse drug reactions should be studied in depth not only for injections but also for all traditional Chinese medicines.It's not clear that it really shouldn't all be written.Children should not just be prohibited from using Chai Hu injection, but all herbal injections should be avoided in children as much as possible., you can take the instructions and see if the adverse reactions or toxic effects are unknown, and maybe one day soon it will be announced that so-and-so herbal injection you have used is banned for children.

Star medicines are not miracle drugs and cannot be used without contraindications; healthcare professionals and patients still need to think carefully before using them.

PS:Only Chai Hu injection is restricted to children, oral preparations are not affected, nor are soups.

Follow the "Drug Counselor Army" headline, more health questions and answers easy to read!

If you have any other questions or opinions, please feel free to discuss them in the comments section.

Hurray for this belated announcement that regulating the use of medications can lead to greater safety of medications for children.

Many Chinese medicine injection instructions in the [adverse reactions], [contraindications] are still unclear, and this time the State Drug Administration of a paper announcement at least let Chaihu injection of adverse reactions and contraindications have a clearer statement.

The revision of every drug specification does not happen without reason. According to Dr. Clove's report, from 1988 to 2005, it was possible to find 24 academic papers reporting 41 cases of adverse reactions. The adverse reactions include irritability, convulsions, fainting, anaphylactic shock, etc. There have even been fatal incidents of drug use due to infusion and intramuscular injection.

It is because of the above background that the State Drug Administration revised the instruction manual of Chai Hu injection, clearly stipulating that it is prohibited for children. In fact, for fever-reducing drugs for infants and children, the only ones whose safety and effectiveness are recognized worldwide are acetaminophen and ibuprofen, and other fever-reducing drugs such as aspirin and nimesulide should not be used, including, of course, the Chai Hu injection that has just been banned.

In fact, a Chinese medicine injection may contain more than a dozen or even dozens of drug ingredients inside, and with so many ingredients directly entering the blood circulation of the human body, it is easy for infusion reactions to occur. The use of Chinese medicine injections has always been controversial, not only for Chaihu injection.

Safe medication for children is no small matter, and stricter regulations to reduce more safety hazards will allow our children to live in a more secure society.

I am "Hanging Pot Pediatrics", using plain and easy to understand words to tell you interested in medical science. If the answer is helpful to you, welcome to follow, retweet, like and leave a comment.

The State Drug Administration issued a document on the 29th, Chaihu injection is prohibited for children, and requires Chaihu injection instructions to add a warning: the drug has the risk of anaphylactic shock, need to have rescue conditions of medical institutions and anaphylactic shock resuscitation training of physicians can only be used.

If you ask me, a medicine that is not meant for first aid, saving lives, and for which there are safer medicines available as alternatives, and yet you risk being resuscitated, such herbal injections should not only not be used in children, but should be banned for all.

Chinese medicine injections were created in the era of shortage of medicine and modernization of Chinese medicine in China. However, TCM injections violate the principles of medication, whether in TCM or modern medicine.

Looking through the ancient books of Chinese medicine, you will not find any theoretical and practical basis for injecting Chinese medicine into blood vessels. Chinese medicine injections are not in line with the medication principle of TCM evidence-based treatment.

Chinese medicine injections are also not in line with the principles of modern medicine. Modern medicine is concerned with weighing the pros and cons of medication, and using medication only when the benefits outweigh the risks. And the first choice for the route of administration is oral. Because the oral preparation is absorbed through the digestive tract, some impurities and toxic substances, will not enter the blood circulation, the risk of drug safety is low. And drugs to enter the body directly from the blood vessels, the drug requirements are quite high. It must be a compound with clear chemical composition, clear physical and chemical properties, and high purity.

However, Chinese medicine injections are often complex and contain a variety of ingredients, such as various types of alkaloids, peptides, polysaccharides, endolipids, etc., which are highly susceptible to anaphylactic shock reactions.

There have been many clinical cases of anaphylactic shock and even death due to the use of Chinese medicine injections, and the use of such a drug, which has no theoretical basis and no definite efficacy but great safety risks, should be rejected.

Feel free to leave a comment with your opinion.

The State Drug Administration (SDA) has finally declared Chai Hu injection off-limits to children. This decision, although belated, is nonetheless heartening. In fact, knowledgeable people have been speaking out about the dangers of various Chinese medicine injections, including Chaihu injection, especially for children, for many years. Records of the side effects of Chaihu injection are uncountable in relevant papers, for example, the Chinese Journal of Traditional Chinese Medicine Information, Volume 8, Issue 5, May 2001, recorded 43 cases of adverse reactions to Chaihu injection (http://www.cnphars.org/docupload/2009-7/7221574351864.pdf),. Among them, there were 24 cases of anaphylaxis, accounting for 55.8%, 5 cases of respiratory reactions, accounting for 11.6%, 4 cases of cardiovascular system reactions, accounting for 9.3%, and 10 cases of skin reactions, accounting for 23.3%. The authors of the paper concluded, "The chances of anaphylaxis triggered by Chaihu injection are quite high, and it is imperative to draw great attention from both doctors and patients." In addition, the authors of the paper found that "infants and young children have poor tolerance to drugs, and six cases of infants and young children with upper respiratory tract infections in this group had more serious allergic reactions after intramuscular injection of Chai Hu Injection. In particular, one of them, a 3-month-old boy, developed spasmodic laryngeal obstruction immediately after intramuscular injection of Chai Hu Injection."

The danger of Chai Hu injection (and other important injections) is twofold. The first is that contemporary Chinese medicine practitioners hold back and refuse to use scientific methods to study and disclose the toxic side effects of Chinese medicinal herbs, and are often willing to use the phrase "the toxic side effects are not yet clear" as a perfunctory excuse, resulting in patients with allergy risks having no way to avoid them in advance, as well as the accumulation in the body of certain latent toxicity that is difficult to observe in the short term. In the case of Chai Hu, it is now known that the Chai Hu saponin it contains will stimulate the vagus nerve, and if the patient has circulatory disorders and a lowered tolerance, it will easily lead to cardiac arrhythmia, slow heart rate, tachycardia, and so on, and in serious cases, it may even jeopardize life. To solve the problems in this area, it is necessary to let Chinese medicine put down the burden of nationalism, thoroughly embarked on the road of scientization.

The other reason is the use of these drugs as injections. The injections go directly under the muscle, bypassing the barrier of the digestive system when taken orally, leading to more immediate allergic reactions, etc., and amplifying the dangers of Chinese medicines such as Chai Hu. This harm is especially true for children.

One, this time, Chai Hu injection changes the instruction manual, the Chinese medicine practitioners will also be a melon people.

Secondly, Chai Hu injection is not Chinese medicine Chai Hu, it cannot cure the disease, and it has nothing to do with Chinese medicine practitioners when accidents happen. Because, the real Chinese medicine practitioners only prescribe tablets for soup pills and powder, will not (and not qualified) to prescribe Chai Hu injection, to the sick child's ass down. If you do, you are practicing in violation of the law and will be immediately suspended from practice.

Welcome to Wukong Q&A, I am a pediatric pharmacist, Mei II Kang, focusing on children's drug safety science for many years, I have my own unique point of view on the interpretation of drugs and parenting. I'm here to talk about this topic of Chaihu injection, and I'd like to talk more about why the safety of herbal injections is always a hot topic.

Why is Chai Hu Injection prohibited for use in children?

Discussions on the safety of Chinese medicine injections have been a hotspot for drug safety research for many years, and it is not surprising that the CFDA has revised the instruction manual for Chaihu injection by adding children's contraindications, because in recent years there have been a number of Chinese medicine injections in the revision of the instruction manual, and they have all added newborns, infants, children, or children's contraindications or precautions to the instruction manual. Prohibited content or not recommended for children's use of the warning.

Why are children suddenly notified of the ban on the use of a drug that was well used in the past! In fact, the reason is very simple, because through the National Center for Adverse Drug Reaction Monitoring collected Chai Hu adverse reaction report summary of the big data research found that the incidence of adverse reactions in the use of this type of traditional Chinese medicine injection in the children's population will be higher than that of adults, or the risk of serious adverse reactions is high, or the use of this type of drug to bring the degree of risk of the drug to be much greater than the benefit, or itself has other relatively safer similar drugs to replace, so it is mandated to ban this drug for children. There are other relatively safer alternatives to the same drug, and therefore the drug is contraindicated in children.

Why is there a high rate of adverse reactions to herbal injections?

The quality of Chinese herbal medicines is affected by the place of origin, harvesting season, soil quality, climate and other planting conditions, and the composition of the same medicinal materials from different basal sources varies even more; Chinese medicine injections have complex formulas, many medicinal flavors, and complicated compositions, and most of them contain alkaloids, lactones, lignans, terpenoids, tannins, peptides, proteins and pigments, etc., and some of which are allergenic in themselves and are susceptible to causing adverse reactions to patients with allergies. In the process of preparation of traditional Chinese medicine injections, appropriate amounts of solubilizers, bacteriostatic agents, stabilizers, and the above substances into the body, will also react with the body to generate harmful substances;

Chinese medicine injections are basically colored, indicating that there are Chinese medicine particles in the liquid, which may be so small that they are not visible to the naked eye, and the color is caused by which ingredient, many of which are unknown; since Chinese medicine injections belong to traditional Chinese medicine, they should be used in accordance with the principle of diagnosis and treatment, but most of them are used by Western medicine; Chinese medicine injections are used in combination with chemical drugs, especially in combination of multiple drugs; and the instructions for Chinese medicine injections are less informative about pharmacology, toxicology, pharmacokinetics, clinical contraindications, precautions and adverse reactions. However, most of the Chinese medicine injections are used in western medicine; Chinese medicine injections are combined with chemical drugs, especially multi-drugs; the instructions for Chinese medicine injections have less information on pharmacology, toxicology and pharmacokinetics, and the information on contraindications, precautions and adverse reactions is incomplete or undetailed, and it is only a simple reference or even vacant. Strictly speaking, this kind of instruction manual is unqualified and cannot guide clinicians to use drugs.

My reminder and vision for the use of herbal injections

In view of the fact that serious adverse reactions of anaphylaxis can occur with Chinese medicine injections, it is important to seek treatment at a medical institution with emergency treatment capability if using them, and if such adverse reactions occur in a small clinic or a small community-type medical institution, the consequences can be imagined. For the sake of the health and safety of the future flowers of our motherland, I believe that in the future, with the development of post-marketing safety re-evaluation of drugs, there may be more Chinese medicine injections that need to be updated, and more Chinese medicine injections will be explicitly prohibited for use in children.

References: 1. Zhou Chaofan, Warning of Adverse Reactions to Chinese Medicine Injections, Chinese Journal of Pharmacovigilance, Vol. 2, 2005. 2. Zeng Bailin, Exploration of Adverse Reactions to Chinese Medicine Injections and Their Countermeasures, Shizhen Journal of Chinese Medicine and Chinese Medicine, Vol. 3, 2010. 3. Li Rong, Progress in Research on the Relevance of the Occurrence of Adverse Reactions to Chinese Medicine Injections, Journal of Proprietary Chinese Medicines, Vol. 5, 2013. 4. Zhou Chaofan, Be cautious in the use of Chinese medicine injections, Chinese Journal of Pharmacovigilance, Vol. 4, 2005.

When I was a kid and had a fever, Chai Hu injection was the first choice, and the only thing I remember from my childhood memory for reducing fever was Chai Hu injection!

Never thought about it, but it turns out I'm nothing more than a couple decades out of 70.

Chaihu injection, the world's first Chinese medicine injection, has been in clinical use for more than 70 years; previously, it was commonly used as a "fever-reducing injection" in the treatment of fever in children. I used to be just one of the common Chinese children.

Chaihu injection: clearing heat and relieving symptoms.

It is used to treat fever in colds, influenza and malaria.

Main material: Bei Chai Hu, auxiliary materials are polysorbate-80, sodium chloride.

Properties: This product is a colorless to slightly yellow or slightly milky white clear liquid; aroma.

Specification: 2ml each.

Usage and dosage: Intramuscular injection, 2~4ml at a time, 1~2 times a day.

Adverse reactions: not yet known. This is the original instruction for Chai Hu Injection, and the adverse reactions are not yet clear. This is a common phenomenon with so many Chinese medicinal preparations, including proprietary Chinese medicines.

On May 29, the State Drug Administration issued the Announcement on the Revision of the Instruction Manual of Chaihu Injection (No. 26, 2018).

Announcement shows that, according to the results of the monitoring of adverse drug reactions and safety evaluation, in order to further protect the public safety of medication, the State Drug Administration decided to increase the warning words on the instruction manual of Chaihu injection, and [adverse reactions] [contraindications] [precautions] and other items to be revised.

Requirements for the revision of the specification of Chai Hu Injection

I. Warnings should be added and should include:

Adverse reactions of this product include anaphylaxis, should be used in medical institutions with rescue conditions, the user should have received training in anaphylaxis rescue, the occurrence of anaphylactic reactions or other serious adverse reactions after the use of the drug must be immediately discontinued and timely treatment.

II. The following should be added to the item [Adverse reactions]:

Allergic reactions: flushed or pale skin, rash, itching, dyspnea, palpitations, cyanosis, decreased blood pressure, anaphylactic shock, anaphylactoid reactions, etc.

Systemic reactions: chills, chills, fever, pain, malaise, etc.

Skin and its accessories: a variety of rashes may be manifested, with urticaria and dermatitis with itching predominating.

Respiratory: breath holding, shortness of breath, dyspnea, etc.

Cardiovascular system: palpitations, chest tightness, cyanosis, drop in blood pressure, etc.

Neuropsychiatric system: dizziness, headache, numbness, vertigo, syncope, convulsions, confusion, etc.

Digestive system: dry mouth, nausea, vomiting, abdominal pain, diarrhea, etc.

Site of application: pain, rash, itching, localized redness, swelling and hardness.

III. [Contraindications] items should be included:

1. This product is contraindicated in persons who are hypersensitive to this product or to preparations containing Chaihu and the excipients listed in the ingredients, or who have a history of serious adverse reactions.

2. Prohibited for children.

IV. The [caveat] subparagraph should include:

1. The adverse reactions of this product include anaphylactic shock, should be used in medical institutions with rescue conditions, the user should have received training in anaphylactic shock rescue, after the use of the drug appeared allergic reactions or other serious adverse reactions must be immediately discontinued and timely treatment.

2. Strictly in accordance with the provisions of the drug specification of the function of the main use, prohibit the use of drugs beyond the functional main use.

3. This product is an antipyretic and antidote to fever, and should not be used by those without fever.

Why is it that after a full seventy years, the State Drug Administration has only revised, or published, the precautions, and even the toxic side effects and adverse reactions of Chai Hu injection?

Bottom line: we're making progress!

Second sentence: we do progress a bit slowly!

Since the establishment of New China, our reform and opening up are forty years old, we can already face some facts; do a comparison, we will know. Just take out a western medicine, you look at the manual, but on the adverse reactions on the long line, after reading the manual of western medicine, no one dares to eat western medicine; why is this? Because the research, observation and listing of western drugs have a rigorous process, during clinical observation, even one case of adverse reactions in the world, will be recorded and written in the manual.

As for our proprietary Chinese medicines, in the column of adverse reactions, the most written is that it is not yet clear. This is why people have the impression that Chinese medicine has no side effects, but in fact it is a medicine with three poisons, and any medicine has side effects.

In the early days of the founding of the country, it is true that the medical, scientific and technological, and supervisory departments were imperfect, and the listing of medicines, including the instruction manuals, could only be suitable for the national conditions at that time; we have to be honest, the Chai Hu injection has relieved our generations from the pain of illness, and Dr. Wang is the beneficiary.

But as our country continues to grow stronger and more confident, and as medical technology continues to advance, our medical norms are bound to become more and more standardized and improved.

Chai Hu Injection, as a first step, has come forward to further publicize its adverse reactions and precautions; and with the improvement of medical standards, we have a new understanding of how to treat fever in children, as well as a new way to deal with it. So, what's meant to be will be, and Chai Hu Injection is just a model for more standardized Chinese medicine. Although this day comes a little later, it is finally here!

So: the banning of the use of children for Chai Hu injections is a sign of our medical progress, that we have become more confident, and that we have become more responsible to our people!