Chemical scientists: If Kagocel is safe, it means it is useless as a medicine

Kagocel: composition and dosage form of the drug

The active component of the medicine is a sodium salt based on carmoxymethylcellulose and a polyphenol compound of plant origin. Kagocel stimulates the formation of human interferons, immune proteins that suppress harmful microflora:

• macrophages;
• lymphocytes;
• endothelial cells;
• granulocytes;
• fibroblasts.

The drug has antimicrobial, immunomodulatory, radioprotective effects. Active against pathogens of ARVI and herpes simplex.

Kagocel is available in the form of tablets for oral use: biconvex, light brown in color with small inclusions. Packaging: contour blisters with 10 cells.

The drug tablet contains 12 mg of gossypol copolymer and auxiliary components:

• starch;
• calcium salts;
• lactose;
• povidone.

Composition of Kagotsela1

One tablet of the drug includes:

• the main biologically active component is kagocel (copolymer of gossypol with carboxymethylcellulose) – 12 mg;
• potato starch – 10 mg;
• calcium stearate – 0.65 mg;
• ludipress (directly pressed lactose, which is a mixture of lactose monohydrate, povidone (Kollidon 30) and crospovidone (Kollidon CL)) - up to 100 mg.

It is important to note that during the production of the drug, special attention is paid to its purification from free gossypol, an inhibitor of dehydrogenase enzymes, which is highly toxic and can have a negative effect on the functioning of the human reproductive system. It’s funny that Kagocel’s alleged influence on this particular system was one of the key topics of his heated discussion in the media and on the Internet. Meanwhile, a unique innovative technology is used to purify the drug from gossypol - Kagocel simply does not contain substances that in one way or another can affect reproductive function.

Mechanism of action

After administration, the active substance is concentrated mainly in the tissues of the liver, lungs, spleen, and kidneys during the day. A small amount accumulates in muscles, brain and blood plasma.

The protective level of interferons grows in the body over 48 hours and lasts up to 5 days from the moment of taking the medicine. This property makes it necessary to prescribe Kagocel at an early stage of the disease - no later than 4 days from the moment of infection.

It is excreted from the body through the intestines. It is not deposited in tissues, has no toxic effect, and does not cause cell mutations.

Chemical scientists: If Kagocel is safe, it means it is useless as a medicine

We remind you that at the end of January, State Duma deputy Sergei Shargunov sent an official request to the Minister of Health Mikhail Murashko to find out whether the antiviral drug Kagocel had undergone the necessary clinical trials. The deputy also asked how accurate is the information in the media that one of the side effects of Kagocel is infertility. Following this, comments appeared in the media, first from Roszdravnadzor, and with it - and (), as well as the Ministry of Health, claiming that clinical studies of the drug were carried out, there was no data on the risks associated with its use.

However, scientists have not believed in a drug with a complex active substance for a long time. Therefore, the RAS Commission for Combating Pseudoscience turned to the Russian University of Chemical Technology. Mendeleev with a request to clarify what the drug “Kagocel” is: “In the media, primarily on television, there is a large-scale advertising campaign for a drug for the treatment of influenza and ARVI called “Kagocel”. The composition of the active substance of the drug declared by the manufacturer causes serious confusion, and therefore I ask you to give professional advice on the issues that have arisen:

1. Sodium salt of a copolymer of (1→4)-6-0-carboxymethyl-β-D-glucose, (1→4)-β-D-glucose and (21→24)-2,3,14,15,21 ,24,29,32-octahydroxy-23-(carboxymethoxymethyl)-7,10-dimethyl-4,13-di(2-propyl)-19,22,26,30,31-pentaoxaheptacyclo [23.3.2.216.20.05. 08.28.27.09.18.012.17] dotriaconta-1,3,5(28),6,8(27),9(18),10,12(17),13,15-decaene - this is the chemical name, chemical formula or something else?

2. Could a substance with a similar chemical name or chemical formula exist in principle?”

The Chairman of the RAS Commission on Combating Pseudoscience, Academician of the Russian Academy of Sciences Evgeniy Aleksandrov received a response from Anna Shcherbina, Vice-Rector for Science of the Russian University of Chemical Technology. Mendeleev, which explains the origin of such a complex name. It was obtained by a chemical substance formed by the interaction of carboxymethylcellulose with gossypol, from the authors of the Russian Federation patent No. 2270708 (“Sodium salt of a copolymer of carboxymethylcellulose and gossypol, pharmaceutical composition and method for the prevention or treatment of viral diseases”).

As the chemists explain, “gossypol, a brown solid, is a phytoalexin polyphenolic compound found in the seeds, roots and leaves of the cotton plant. Gossypol is a biologically active compound. It exhibits antiviral and antimalarial activity.” Its side effects include suppression of spermatogenesis and hepatotoxicity, “which prevent its use as a medicine.”

Academician of the Russian Academy of Sciences: “Ergoferon”, “Anaferon” and other “immunomodulators” are treated only with sugar

In the official response of the Russian Chemical-Technological University. Mendeleev scientists draw attention to the fact that in the polymer molecule “Kagocel” “gossypol is in a form associated with carboxymethylcellulose by covalent bonds and, in accordance with this, the structural element of gossypol cannot exhibit the biological activity inherent in the individual compound . In gossypol, we recall, it is antiviral and contraceptive, as well as toxic. However, in the human body this bound substance decomposes into its components, that is, the same “pure” gossypol is released - contraceptive and toxic. Scientists reassure: “the decomposition of this polymer compound with a molecular weight of more than 100,000 Da (Da - atomic mass units for measuring atoms and molecules - Ed.) in biological media with the formation of toxic gossypol is quite slow, as a result of which its concentrations in the human body are at oral use in accordance with the instructions cannot reach values ​​hazardous to health.”

The RAS Commission for Combating Pseudoscience still has questions for the experts of the Russian University of Chemical Technology. Mendeleev. As Sergei Finaev, advisor to the chairman of the commission, said, scientists are going to send another request to the university, since they have not seen a specific answer to the question of what is the “sodium salt of a copolymer of carboxymethylcellulose and gossypol, indicated by a complex formula, a pharmaceutical composition and a method for the prevention or treatment of viral diseases.” : “Apparently, this is a polymer,” says Sergei Finaev, “which means it tends to accumulate in the body. Who studied this process and how remains to be seen.” It is clear that chemists will not be able to perform pharmacokinetic studies, which are usually carried out during preclinical studies of a drug. But they can tell whether Kagocel is actually excreted from the body unchanged (and therefore does no harm or benefit) or whether it accumulates and decomposes “with the formation of toxic gossypol quite slowly.”

Chief pharmacologist of St. Petersburg: We treat ARVI with the contraceptive “Kagocel” and the useless “Arbidol”

We remind you that Kagocel is an officially registered drug in Russia. This means that before allowing a drug onto the market, the Ministry of Health, in accordance with Russian legislation, conducted an examination of data from preclinical and clinical trials confirming its quality, effectiveness and safety .

As “Doctor Peter” said earlier, “Kagocel” - today an immunostimulating drug “for the treatment of ARVI” until recently had a completely different purpose: “it was used for a long time as a contraceptive drug, causing a disorder of spermatogenesis, and then suddenly it became an immunomodulator. In the late 1990s, a WHO study group on methods of regulating male fertility concluded that the risks of its use outweighed the benefits and its use in its pure form as a contraceptive was prohibited. Simply put, the use of gossypol, and now Kagocel, led to male infertility.”

© DoctorPeter

How to take Kagocel

The tablets are taken orally without chewing or breaking into pieces. Drink plenty of water. Meal times don't matter. Gastric juice does not affect the absorption of the drug into the bloodstream.

For prevention, adults and adolescents over 12 years of age are recommended to use Kagocel in cycles:

• 2 tablets each once within 2 days;
• repeated 2-day intake after a break of 5 days.

This scheme contributes to the formation and maintenance of the body’s defenses for a week after the next use of the medicine.

For the treatment of ARVI, the following is prescribed:

• 2 pills three times a day for the first 2 days;
• 1 pill three times a day on days 3–4.

A total of 18 tablets are enough for a 4-day course. Longer treatment is irrational.

When treating herpes, Kagocel is taken for 5 days: 2 pills three times a day. The course is designed for 30 tablets.

Comprehensive preclinical research in 2022 in Russia

In 2022, specialists from the State Research Institute of General Pathology and Pathophysiology, together with colleagues from the Chemical-Pharmaceutical Institute TsKhLS-VNIHFI, conducted additional independent preclinical studies of Kagocel on laboratory animals (rabbits, rats, white mice), which confirmed the results of previous tests: the drug Kagocel non-toxic even in doses that are 20–40 times higher than therapeutic.

Also NIIEM im. N.F. Gamaleya RAMS conducted additional studies to study the mutagenic activity of Kagocel: the absence of mutagenic activity in the drug was confirmed - as a result of the experiment, no mutated cells or disturbances in the structure of their genome were detected under the influence of Kagocel.

Contrary to false rumors that were and are still spreading in the media that Kagocel has a negative effect on male potency, preclinical studies have not confirmed this. In 2017, specialists from the Federal State Budgetary Institution “Research Center for Toxicology and Hygienic Regulation of Biological Products of the Federal Medical and Biological Agency” and the Federal State Budgetary Institution “Research Institute of General Pathology and Pathophysiology” dealt with this issue. It was shown that the administration of Kagocel, neither in a preventive nor in a therapeutic regimen, did not in the slightest affect the reproductive health of experimental animals.

In the same 2022, at the Research Institute of Pharmacology and Regenerative Medicine named after. E.D. Goldberg Tomsk National Research Medical Center of the Russian Academy of Sciences conducted special studies of the effect of Kagocel on the fertility and quality of the offspring of laboratory animals. The data obtained are summarized in articles by T.G. Borovskaya and V.A. Mashanova, published in peer-reviewed, respected scientific and medical journals “Antibiotics and Chemotherapy”, as well as “Serbian Journal of Experimental and Clinical Research”.

The experiments carried out at the research institute completely refute the information disseminated by unscrupulous media. A group of scientists who studied the effect of Kagocel on laboratory rats came to several irrefutable conclusions about the drug:

• It does not suppress reproductive function.
• Does not contribute to spontaneous abortion.
• Does not affect the genome of germ cells.
• Does not affect the health of the offspring either in the short or long term.
• Does not cause deviations in the morphological state of the gonads.

Studies have shown that the drug does not have a negative effect on both adults and immature cubs. The age of the cubs who took part in the study corresponds to human age of 2-3 years. This means that the drug is also safe for children aged 3 years and older. The results obtained are part of the evidence base for the reproductive safety of using the drug Kagocel for the prevention of influenza and other respiratory viral infections in frequently ill children and adolescents.

Based on safety data obtained from the results of preclinical studies, it was shown that the drug belongs to a safe substance (toxicity class 5).

In total, more than 20 studies involving more than 21,000 people were conducted to assess the safety of Kagocel - and each of them confirmed the safety of the drug.

And finally, an interesting fact that does not concern preclinical and clinical studies. Over 16 years of use of the drug, with the sale of about 200 million packages of the drug Kagocel (over the specified period, more than 100 million patients received treatment with the drug Kagocel), the manufacturing company registered and analyzed only 160 adverse reactions, the possibility of which is indicated in the Instructions for Medical Use drug. This is “as much as” 0.00008% of the number of packages sold over 16 years.

How to take Kagocel for children

Children 3–6 years old with the flu are prescribed:

• 1 pill twice a day for the first 2 days;
• on days 3 and 4 - 1 pill once.

Children 6–12 years old can take:

• three times a day, 1 pill in the first 2 days;
• in the remaining 2 days - 1 pill twice a day.

To prevent diseases in childhood, 2 tablets are enough for 7 days: 1 pc. daily for the first 2 days, then at a 5-day interval. Preventive treatment can be repeated throughout the epidemic season.

Is it possible to combine Kagocel with alcohol?

There is no data on the interaction of the drug components with ethanol and the formation of toxic compounds when used together. However, under the influence of alcohol, the mechanism of interferon formation may be disrupted. In such cases, the therapeutic effect of Kagocel will be insufficient or will disappear.

In addition, alcohol may increase the risk of allergic reactions and side effects while taking the medication. For these reasons, you should abstain from alcohol for a period of at least 5 days from the last time you took Kagocel.

Does Kagocel threaten infertility?

Buyers in the Moscow pharmacy hypermarket of the 36.6 chain.
Photo: Artem Geodakyan/TASS The active ingredient of the drug is gossypol (a natural compound found in cotton), associated with oxidized carboxymethylcellulose.

Gossypol can inhibit spermatogenesis and has even been studied in clinical studies for use as a male contraceptive. However, this idea had to be abandoned. Firstly, in 20% of cases the effect of the drug was irreversible, that is, it made the man infertile forever, and secondly, according to preliminary data, there is a possibility that gossypol has genetic toxicity.

The manufacturer of Kagocel claims that gossypol is included in the drug in bound form and is not released during chemical transformations in the body, and therefore cannot inhibit spermatogenesis. At the same time, a number of experts, for example, the authors of the work “Leaders in Sales of Over-the-Counter Drugs and Problems of Their Safety,” question this statement.

If we assume that high-molecular-weight Kagocel is broken down into smaller molecules during absorption in the gastrointestinal tract, then, according to Doctor of Medical Sciences, Professor of RUDN University E. Ushkalova and her co-author, research fellow at the Scientific Center for Advanced Medical Practice named after. V.I. Kulakova N. Chukhareva, taking the drug “in the prepubertal and pubertal period (that is, in children and adolescents) is even more dangerous in terms of its effect on reproductive functions than in adulthood.”

The authors of the article believe that until the results of targeted studies are obtained to study the long-term consequences of Kagocel use in males, including children and adolescents, the drug cannot be characterized as safe with a high degree of confidence.