This "fever-reducing magic medicine" has been cancelled by the Food and Drug Administration! It has been banned in many countries before..

On November 12, the State Drug Administration issued the Notice on Cancelling the Registration Certificates of 34 Drugs Including Mercurochrome Solution (No. 132 of 2021). The Notice canceled the registration certificates of 34 drugs including Mercurochrome Solution, among which Analgin Tablets was on the cancellation list.

In the impression of several generations, Analgin tablets can be said to be a "miracle drug for reducing fever."

Analgin has serious adverse reactions

It has been banned in many countries

Analgin is a pyrazolone antipyretic analgesic, its main ingredients are "aminopyrine and sodium sulfite".

Data shows that from 1922 to 1934, aminopyrine was popular in Europe and the United States as a new type of antipyretic and analgesic drug, and was used by people to reduce fever and relieve pain. However, people gradually found that patients taking this drug would have a variety of side effects, such as causing a decrease in leukocytes in peripheral blood, a decrease in immunity, and various infections. In 1934, 1,981 people died of this disease in the United States alone, and more than 200 people died in Europe.

In this context, several countries have banned analgin-related products:

In 1965, the Australian health department banned the import of Analgin; in July 1976, Norway withdrew Analgin from the market; in 1977, the Philippines stipulated that it should only be used as a last resort under proper supervision when other less toxic antipyretics and methods are ineffective and unacceptable when there is a serious threat to life. In 1977, the U.S. FDA (U.S. Food and Drug Administration) officially banned Analgin and withdrew the drug from the U.S. market, and the clinical application of multiple dosage forms was stopped.

The 2013 annual report released by the Indian Ministry of Health and Family Welfare also clearly mentioned that from June 18, 2013, the manufacture, sale and distribution of human use metamizole and all preparations containing metamizole will be stopped immediately.

Since then, more than 30 countries including Australia, Norway and the Philippines have issued orders to ban or restrict the use of analgin.

Studies have shown that the side effects caused by the clinical application of Analgin are mainly reflected in several aspects:

1. Blood: It can cause agranulocytosis, with an incidence of about 1.1%. It has an acute onset and is fatal in severe cases. It can also cause autoimmune hemolytic anemia, thrombocytopenic purpura, aplastic anemia, etc.

2. Skin: It can cause allergic manifestations such as urticaria and exudative erythema. In severe cases, it can cause exfoliative dermatitis and epidermolysis.

3. Local reactions: There may be redness, swelling and pain at the injection site, which may subside after a few days. Some patients may present with symptoms of septicemia, subcutaneous hemorrhages, or purple-black pus, which often take several months to heal.

4. Anaphylactic shock: allergic rash or drug fever, urticaria, severe cases may have exfoliative dermatitis, epidermolysis bullosa and even death. In some cases, anaphylactic shock may occur, even leading to death.

In fact, the drug adverse reaction information bulletins issued by my country's National Center for Adverse Drug Reaction Monitoring have also involved this drug many times. As early as 2002, my country's National Center for Adverse Drug Reaction Monitoring collected data on suspected adverse drug reactions caused by analgin, including:

11 cases of anaphylactic shock, 7 of which were fatal;

16 cases had hematologic reactions, including 1 death;

31 cases of skin and appendage reactions, including 4 deaths;

There were 17 cases of urinary system reactions, including 5 deaths;

9 cases had digestive system reactions, including 1 death;

There were also 8 cases of severe reactions such as respiratory and cardiac arrest, incontinence, etc., one of which was fatal.

The above does not include adverse reaction cases recorded by local monitoring centers.

There are many production batches of Analgin

Most products have been removed from shelves

Analgin was previously widely used in my country, and some township hospitals, health centers and even hospitals in prefecture-level cities still prescribe Analgin to patients.

In recent years, my country has repeatedly introduced policies to restrict the use of analgin products.

On September 4, 1982, the former Ministry of Health issued the "Notice on the Elimination of 127 Drugs". In this list of eliminated drugs, "Compound Analgin Tablets" were eliminated in the same batch, but "Analgin Tablets", "Analgin Injection", "Analgin Injection", "Analgin Nasal Drops" and so on were retained.

On March 17, 2020, the State Drug Administration issued the "Announcement on the Cancellation of the Drug Registration Certificates for Analgin Injection and Other Products" (No. 29 of 2020) and the "Announcement on the Revision of the Instructions for Analgin Related Products" (No. 34 of 2020), requiring the cessation of the production, sales and use of Analgin Injection and other products in my country, and revising the instructions for Analgin Tablets, Chongganling Tablets, Chongganling Capsules, Compound Artemisia Analgin Tablets and other products.

Among them, the "Requirements for the Revision of the Instructions for Analgin Tablets" requires the instructions for Analgin Tablets to be revised in eight aspects, including warnings, indications, usage and dosage, adverse reactions, contraindications, precautions, use by pregnant and lactating women, and use by children. The "Requirements" revised the indications of the drug to "antipyretic for acute high fever, and can also be used for short-term treatment of acute pain, such as headache, migraine, muscle pain, joint pain, dysmenorrhea, etc.", and clearly pointed out that the drug may cause serious adverse reactions in the blood system, and is generally not used as the first choice of medication. It is only used when the condition is serious and there is no other effective drug treatment. It is prohibited for children under the age of 18 and women in late pregnancy.

The reporter checked the website of the National Medical Products Administration and found that as of November 13, 2021, there were 855 drug approval numbers related to Analgin in my country, and there were hundreds of manufacturers. Categories including "Analgin Injection", "Analgin Drops" and "Analgin Nasal Drops" have been removed from the shelves, and five categories are still retained, including "Analgin Tablets", "Analgin", "Compound Artemisia Analgin Tablets", and "Zhongganling Tablets" and "Zhongganling Capsules" containing Analgin ingredients.

The main one among them is "Analgin Tablets", and the approval numbers account for more than 90%.

(Source: Health Times, Medical Messenger)