The Japanese will stop producing the popular antibiotic vilprafen in Russia

An international pharmaceutical company headquartered in Japan, Astellas, has decided to withdraw the antibiotics vilprafen and vilprafen solutab (international nonproprietary name - josamycin) from the Russian market, RBC has found out.

In the second half of December, Russian pharmacies almost ran out of stocks of these drugs. Thus, according to the online pharmacy aggregator Megapteka (it sees the assortment of more than 10 thousand points throughout the country), in Moscow on December 21, vilprafen solutab was available in only one of the 2.5 thousand pharmacies connected to the service. There was no Vilprafen at all. There were no medications with josamycin in any pharmacy in St. Petersburg, Perm, Tambov, in Voronezh they were available only in 19 out of 461 points connected to the service, in Samara - in 25 out of 364.

According to the state register of medicines, vilprafen and vilprafen solutab are produced by the Ortat factories (part of the R-Pharm group of Alexey Repik), as well as Zio-Zdorovye (Pharmeko holding, founded by Vladimir Babiy).

The Zio-Zdorovye company, which an RBC correspondent contacted as a consumer, reported that Astellas had decided to stop producing josamycin in RUSSIA and withdraw it from the market. The Russian representative office of the Japanese pharmaceutical company, which RBC contacted in a similar way, confirmed the cessation of production and the withdrawal of the drug from the market of vilprafen, clarifying that its other drugs will remain. RBC's interlocutors did not name the reasons for this decision.

In response to an official request to Pharmaco, which includes Zio-Zdorovye, they recommended contacting Astellas. Astellas and R-Pharm did not respond to RBC’s requests.

What is vilprafen used for?

Preparations based on josamycin are used in the treatment of infections of the upper and lower respiratory tract and ENT organs, infections in dentistry and ophthalmology, skin and soft tissues, gastrointestinal diseases and others. Vilprafen and Vilprafen Solutab differ in their release form - they are produced in the form of film-coated tablets and dispersible (that is, dissolving) tablets.

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DSM Group CEO Sergei Shulyak considers the withdrawal of vilprafen from the Russian market an unexpected decision. He notes that this drug has no analogues in Russia and so far it is not known that anyone is going to release it. At the same time, Shulyak notes that vilprafen is in demand and believes that patients will not be left without this medicine . It is possible that one of its current manufacturers will receive a compulsory license to produce the drug, Shulyak concludes.

What is happening to the demand for antibiotics in Russia

According to statistics, the demand for antibiotics is decreasing this year. According to the analytical company DSM Group, in the ten months of 2023, 191.2 million packages of antibiotics were sold in the country for 48.9 billion rubles. (data includes pharmacy sales and sales through government procurement). This is 23 and 20% less, respectively, than for the same period in 2022.

Over the past full four years, antibiotic sales in volume terms expectedly peaked in 2020, when the CORONAVIRUS pandemic began in the country. Then, in particular, 419.3 million packages of these drugs were sold for more than 76 billion rubles. In monetary terms, the most antibiotics were sold in 2021 - by 91.7 billion rubles, although in packages there was a decrease to 403.5 million units. In 2022, consumption of antibiotics fell 1.4 times, to 290.6 million packages, although sales in monetary terms amounted to 72.3 billion rubles.

The most purchased antibiotics by sales volume in monetary terms include drugs with INNs cefixime, azithromycin, amoxiclav, ceftriaxone and amoxicillin .

At the same time, sales of Astellas antibiotics leaving the Russian market, despite a general decline in demand for this category of drugs, have been growing this year. Sales of antibiotics with the INN josamycin at the end of ten months of 2023 amounted to 1.4 million packages for 915.8 million rubles. This is almost 17 and 15% more, respectively, than in the same period last year. The most packages of josamycin were sold in 2019 - 2.8 million for 1.8 billion rubles. There was a slight increase in value in 2021, but there was a decline in units that continued into 2022.

What awaits patients after the disappearance of vilprafen

According to the Roszdravnadzor register, the last batches of vilprafen solutab produced by Zio-Zdorovye were put into circulation in July of this year. Information on the release of vilprafen could not be found.

The remaining stocks of vilprafen and vilprafen solutab currently available in Russian medical organizations will last for a little more than six months; in pharmacies there are stocks left for less than a month, the press service of the Ministry of Health told RBC with reference to the analytical showcase of the Russian government.

The Ministry of Health also noted that josamycin can be replaced with drugs with the international nonproprietary names azithromycin and clarithromycin, “for which there has been a steady introduction into civilian circulation.” According to the Ministry of Health, the remaining amounts of azithromycin in circulation cover more than a year's need, and clarithromycin - eight months.

At the same time, the ministry did not comment on the issue of stopping the production of josamycin in Russia.

However, there may be other difficulties with the drugs specified by the Ministry of Health. Due to the incorrect and excessive use of antibiotics during the coronavirus pandemic, which did not bring any effect, the population has developed high resistance to such drugs, says DOCTOR of Medical Sciences and Professor Svetlana Kanevskaya. Among the main mistakes, she names the prescription of antibiotics not according to indications (for example, for viruses that such drugs do not kill), as well as non-compliance with the dosage regimen in terms of frequency and duration of treatment.

Marina Berezhnaya, HEAD of the emergency department of the European Medical Center, agrees with her. She also notes that due to the uncontrolled use of antibiotics by the population, microbes in patients’ bodies become “accustomed” to the drugs, and doctors do not receive the desired treatment effect. The key mistake, she says, is self-medication, when a person “prescribes” himself an antibiotic based on the advice of a relative, friend, or his own similar experience in the past. Another mistake is the excessive reinsurance of the doctor, who finds it easier to prescribe as many drugs as possible, including due to insufficient examination to formulate the most correct and effective treatment plan. “Simply put, just in case,” concludes Berezhnaya.

What the WHO says about antibiotic resistance

By 2050, antibiotic resistance could cause the death of 10 million people a year - this is the conclusion reached by the Regional Office for Europe of the World Health Organization (WHO). In November of this year, the organization reported that antibiotic resistance already kills 5 million people every year, about half a million of them in Europe and Central Asia.

WHO has included antibiotic resistance as one of the ten global threats to the world. The situation is worst in countries with low and middle incomes, the organization notes. According to her, antibiotics are most often used for colds, flu symptoms, sore throat and cough. Moreover, such symptoms are most often caused by viruses, which are not affected by antibiotics, the WHO emphasizes.

What does the Ministry of Health offer?

In October of this year, the Ministry of Health developed a draft order in which it proposed to abandon the use of antibiotics in the treatment of ARVI. According to the document, the ministry wants to completely abandon these drugs for colds. It is planned to replace them with antiviral drugs, the list of which has expanded - in addition to arbidol, ingavirin and zanamivir, it may include kagocel, triazavirin, tilorone and nobazit.

The current standard of treatment for ARVI in Russia has existed since 2013. According to it, patients are prescribed antibiotics azithromycin, cephalosporin, cefoperazone and others.

Doctors interviewed by RBC consider the decision to exclude antibiotics in the treatment of ARVI to be correct. According to Kanevskaya, the disease is caused by viruses, which these drugs do not treat, and antibiotics are necessary if a bacterial infection is added to a viral infection.

Berezhnaya also considers it inappropriate to prescribe antibiotics for the classic course of a common respiratory infection - she insists that only a doctor can determine the indications for any type of treatment .