pharmacovigilance

Objective. To analyze spontaneous reports (SRs) from the Russian database of adverse reactions (Automated information system «Pharmacovigilance» of Roszdravnadzor), containing information on fatal outcomes during ceftriaxone treatment, and to identify factors associated with an increased risk of death with ceftriaxone use. Materials and Methods. The study included 122 SRs concerning fatal cases during ceftriaxone therapy. All SRs were submitted to the Russian pharmacovigilance database from 06 May 2019 to 23 November 2022.

Objective. To perform pharmacoepidemiological analysis of spontaneous reports of adverse drug reactions (ADRs) occurred during macrolide group antibiotics prescription and registered in the “Pharmacovigilance 2.0” subsystem of the Federal Service for Surveillance in Healthcare. Materials and Methods. A retrospective pharmacoepidemiological analysis of spontaneous reports of ADRs arising from the use of all macrolide and azalide antibiotics registered in Russia and registered in the electronic database of the “Pharmacovigilance 2.0” subsystem of the Federal Service for Surveillance in Healthcare for the period from 01.

Objective. The purpose of this study is to systematize and comprehensively evaluate safety data on the drug favipiravir using the national pharmacovigilance database of the Russian Federation. Materials and Methods. The report is based on spontaneous reports in the national automated information system of pharmacovigilance of the Russian Federation for the reporting period from 01.01.2020 – 04.07.2022. To identify safety signals we used disproportionality analysis, to estimate consumption of favipiravir – indicator of the number of consumed DDDs, we additionally performed review of concomitant therapy as a risk factor for serious adverse reactions.

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.

Due to increased use of antibiotics in current clinical practice it is very important to evaluate all risks of antimicrobial therapy. Pharmacovigilance plays a vital role in ensuring that doctors, together with the patient, have enough information …