Drug-Induced Anaphylaxis: National Database Analysis

Author:

Butranova Olga1ORCID,Zyryanov Sergey12ORCID,Gorbacheva Anastasia1,Asetskaya Irina1,Polivanov Vitaly3ORCID

Affiliation:

1. Department of General and Clinical Pharmacology, Peoples’ Friendship University of Russia Named after Patrice Lumumba (RUDN), 6 Miklukho-Maklaya St., 117198 Moscow, Russia

2. Moscow City Health Department, City Clinical Hospital No. 24, State Budgetary Institution of Healthcare of the City of Moscow, Pistzovaya Srt. 10, 127015 Moscow, Russia

3. Pharmacovigilance Center, Information and Methodological Center for Expert Evaluation, Record and Analysis of Circulation of Medical Products under the Federal Service for Surveillance in Healthcare, 4-1 Slavyanskaya Square, 109074 Moscow, Russia

Abstract

(1) Background: National health system databases represent an important source of information about the epidemiology of adverse drug reactions including drug-induced allergy and anaphylaxis. Analysis of such databases may enhance the knowledge of healthcare professionals regarding the problem of drug-induced anaphylaxis. (2) Methods: A retrospective descriptive analysis was carried out of spontaneous reports (SRs) with data on drug-induced anaphylaxis (SRsAs) extracted from the Russian National Pharmacovigilance database (analyzed period 2 April 2019–21 June 2023). The percentage of SRsAs among SRs of drug-induced allergy (SRsDIAs) was calculated, as well as of pediatric, elderly, and fatal SrsAs. Drugs involved in anaphylaxis were assessed among total SRsAs, pediatric, and elderly SRsAs, and among fatal SRsAs. Demographic parameters of patients were assessed. (3) Results: SRsAs were reported in 8.3% of SRsDIAs (2304/27,727), the mean age of patients was 48.2 ± 15.8 years, and females accounted for 53.2% of cases. The main causative groups of drugs were antibacterials (ABs) for systemic use (44.6%), local anesthetics (20.0%), and cyclooxygenase (COX) inhibitors (10.1%). Fatal SRsAs were reported in 9.5% (218/2304) of cases, the mean age of patients was 48.0 ± 16.7 years, and females accounted for 56.4% of cases. Pediatric SRsAs accounted for 3.9% of pediatric SRsDIAs and 5.8% of all SRsAs, with a mean age of 11.8 ± 4.5 years, and females acccounted for 51.9% of cases. Elderly SRsAs accounted for 2% of elderly SRsDIAs and 2.8% of all SRsAs, and the mean age was 73.0 ± 5.3 years, and females accounted for 43.5% of cases. ABs caused 40% of SRsAs in the elderly, 42.9% in children, and 50% of fatal SRsAs. (4) Conclusions: Our study revealed a relatively high proportion of anaphylaxis among SRs of drug-induced allergy. ABs were the most prevalent causative agents, especially in fatal SRsAs.

Publisher

MDPI AG

Subject

Drug Discovery,Pharmaceutical Science,Molecular Medicine

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