Safety profile assessment of drug products used for the pathogenetic treatment of COVID19 | CMAC

Safety profile assessment of drug products used for the pathogenetic treatment of COVID19

Clinical Microbiology and Antimicrobial Chemotherapy. 2021; 23(3):314-329

​ Syraeva G.I., Mishinova S.A., Kolbin A.S., Eremenko E.O.
10.36488/cmac.2021.3.314-329
COVID-19 SARS-CoV-2 drug products pharmacovigilance pharmacotherapy adverse drug reaction adverse event
Section
Personal Experience
Type
Review
Publication
Clinical Microbiology and Antimicrobial Chemotherapy. 2021; 23(3):314-329

Objective.

To review and summarize literature data in studies of safety of the drug products used for the pathogenetic treatment of COVID-19.

Materials and Methods.

As the first stage of monitoring the drug’s safety, which are used in the treatment of COVID-19 in Russia, a systematic review of studies of the drug’s safety profiles was carried out: mefloquine, hydroxychloroquine, azithromycin, lopinavir/ritonavir, favipiravir, tocilizumab, olokizumab, baricitinib in the international databases Medline, PubMed, ClinicalTrials.gov and Cochrane Library for the period 2019–2021.

Results.

The review included 51 articles that met the selection criteria. Based on the results of the review, it can be concluded that the safety profile (frequency, severity and severity) of most drugs repurposed for COVID-19 corresponds to those for the registered indications. At the same time, according to world experience, there is an increase in the number of reports of adverse drug reactions of hydroxychloroquine and azithromycin, which is provoked by the active use of these drugs for combination therapy.

Conclusions.

According to the literature, a high incidence of adverse events was noted in hydroxychloroquine, chloroquine and azithromycin. Subsequent analysis and comparison of the safety profiles of hydroxychloroquine, chloroquine and azithromycin with data from the national automated information system (AIS) database of Roszdravnadzor is a necessary component of effective and safe pharmacotherapy for COVID-19.

Gulnara I. Syraeva

Pavlov First Saint-Petersburg State Medical University, Saint-Petersburg, Russia
Research Center Eco-safety, Saint-Petersburg, Russia

Mishinova S.A.

Pavlov First Saint-Petersburg State Medical University, Saint-Petersburg, Russia

Alexey S. Kolbin

Pavlov First Saint-Petersburg State Medical University, Saint-Petersburg, Russia

Eremenko E.O.

Pavlov First Saint-Petersburg State Medical University, Saint-Petersburg, Russia

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