No cases of serious side effects of the Favipiravir-based preparations for treatment of patients with the novel coronavirus infection have been recorded in Russia, Healthcare Ministry aide Alexey Kuznetsov told journalists on Friday.
“Since the moment of registration the preparations are included in the compulsory drug marking system which allows to control the movement of each pack. According to the legislation, the oversight of pharmaceuticals is performed by Roszdravnadzor [the Federal Service for Surveillance in Healthcare]. No cases of serious adverse side effects of use of the preparations were registered in our country,” he said.
The official also noted that Russian Favipiravir-based preparations have proven their safety and effectiveness according to the results of three phases of clinical trials and are successfully used for treatment of the COVID-19 patients.
Earlier, the Izvestiya daily reported that pharmacologists analyzed the data on the safety of Favipiravir and preparations on its base used for the treatment of the coronavirus infection.
According to them, the instructions for the Japanese Avigan preparation mention the possibility of motor disorders in patients, including sleepwalking and heightened risk of falls. The experts think that this can be related to the influence of the preparation on central nervous system.
“The information on possible adverse side effects of use of the favipiravir preparations, cited by a number of media outlets, was obtained from the publication of the PharmaCOVID Information Center for drug therapy of patients with the novel coronavirus infection on the basis of Russia’s Medical Academy of Continued Professional Education of Russia’s Healthcare Ministry. This publication was designated exclusively for the comprehensive information of the professional community and the support of decisions of practicing physicians and was based on the data included in the instructions for the medicinal use of the Avigan preparation (Japan) where possible motor disorders were noted in elderly flu patients. I would emphasize that the said side effects of the Japanese preparation are related precisely to the flu and not to the effect of the preparation,” he concluded.
Earlier, the Federal Service for Surveillance in Healthcare reported that three drugs with the international nonproprietary name (INN) of Favipiravir were registered in Russia: Avifavir, Areplivir, and Coronavir. The agency has not received any reports on any reactions related to non-specific motor disorders during the use of the medications.
SARANSK, RUSSIA – OCTOBER 6, 2020: A worker oversees the process of blister packaging of pills at the Biokhimik pharmaceutical plant where the Areplivir drug developed by Promomed for COVID-19 treatment is produced, in Saransk, capital of Mordovia. Founded in 1959, Biokhimic specialises in manufacturing different groups of antibiotics, including penicillins, cephalosporins, carbapenems, aminoglycosides.
Areplivir was registered by the Russian Healthcare Ministry on June 23, 2020, being the second Russian-made drug based on Favipiravir, a synthetic medication earlier used to treat rare viral infections, including Ebola virus, along with complicated influenza diseases.