Retrospective Analysis of Spontaneous Reports of Fatal Adverse Reactions Associated with Lidocaine

Abstract

SCIENTIFIC RELEVANCE. Pain and pain relief are among the most important problems that arise during medical procedures. Lidocaine is used not only as an anaesthetic during interventions but also as a diluent for other medicinal products. Analysis of adverse drug reactions (ADRs) associated with lidocaine contributes to studying lidocaine toxicity and, as a result, developing measures to reduce side effects.AIM. The authors aimed to conduct a retrospective analysis of spontaneous reports of fatal ADRs associated with lidocaine.MATERIALS AND METHODS. This study analysed spontaneous ADR reports of fatal outcomes associated with lidocaine submitted to the federal ADR database in the Automated Information System of the Federal Service for Surveillance in Healthcare of the Russian Federation (Pharmacovigilance, versions 1.0 and 2.0) from 1 January 2008 to 31 December 2020.RESULTS. The ADR reports included 102 fatal outcomes associated with lidocaine. Most often, lidocaine was prescribed as a local anaesthetic or as a diluent for antibacterials. Studying the administered lidocaine doses, the authors identified several overdose cases. Most life-threatening conditions were due to hypersensitivity reactions of anaphylactic shock (54 cases, 52.9%). Lidocaine administration was accompanied by loss of consciousness, respiratory failure, and cardiac arrest in 10 cases (9.8%). Convulsions were a significant clinical sign in 9 cases (8.8%).CONCLUSIONS. Awareness of the risks of systemic toxic effects of local anaesthetics, including lidocaine, necessitates the practical implementation of certain safety measures, such as allergy skin tests before administration and mandatory monitoring of doses and patients’ well-being after administration.

Keywords

• lidocaine
• toxic reactions
• adverse drug reactions
• anaphylaxis
• pharmacovigilance
• spontaneous reports
• drug safety