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

Clinical Microbiology and Antimicrobial Chemotherapy. 2023; 25(1):34-40

​ Skryabina A.A., Nikiforov V.V., Shakhmardanov M.Z., Zastrozhin M.S., Skryabin V.Yu., Sychev D.A.
10.36488/cmac.2023.1.34-40
antibiotics pharmacovigilance spontaneous reports macrolides adverse drug reactions
Section
Antimicrobials
Type
Original Article
Publication
Clinical Microbiology and Antimicrobial Chemotherapy. 2023; 25(1):34-40

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 01.04.2019 to 30.11.2022 was performed.

Results.

Analysis of the number of spontaneous reports of ADRs, their structure, outcomes and severity criteria was performed. The most clinically significant ADRs were identified, the occurrence of which was reported to pharmacovigilance bodies. The results of a retrospective pharmacoepidemiological analysis showed that the development of complications of pharmacotherapy in most cases was associated with the use of azithromycin and clarithromycin. The main clinical manifestations of adverse drug reactions were skin and subcutaneous tissue disorders, gastrointestinal disorders, as well as general disorders and injection site reactions.

Conclusions.

It was found that the reported events generally corresponded to the general spectrum of ADRs typical for individual representatives of macrolide and azalide antibiotics.

Anna A. Skryabina

Pirogov Russian National Research Medical University, Moscow, Russia

Nikiforov V.V.

Pirogov Russian National Research Medical University, Moscow, Russia

Shakhmardanov M.Z.

Pirogov Russian National Research Medical University, Moscow, Russia

Zastrozhin M.S.

Russian Medical Academy of Continuous Professional Education, Moscow, Russia

Skryabin V.Yu.

Russian Medical Academy of Continuous Professional Education, Moscow, Russia
Moscow Research and Practical Centre on Addictions, Moscow, Russia

Dmitriy A. Sychev

Russian Medical Academy of Continuous Professional Education, Moscow, Russia

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