adverse drug reactions | CMAC

adverse drug reactions

Adverse drug reactions of macrolide therapy: analysis of spontaneous reports according to the Pharmacovigilance system

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.

Report of the Russian database on adverse drug reactions for COVID-19-related drugs with a focus on favipiravir

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.

Gastrointestinal adverse drug reactions and antibiotic-associated diarrhea during antibiotic therapy in outpatient practice: prevention and treatment

Adverse drug reactions affecting gastrointestinal tract, quite often with the development of antibioticassociated diarrhea, are the most common undesirable effects of antibiotic therapy in outpatient practice. This review provides modern approaches …

Emerging Concepts in Use of Macrolides in Pregnancy and Lactation

This paper reviews general issues of the use of antimicrobial agents in pregnant women. Currently available data on safety of macrolides during pregnancy and lactation are considered with the focus on several indications for their therapeutic and …