Background: Some evidence of significant patient morbidity or mortality has been reported with the use of local anaesthetics (LAs). The most common adverse drug reactions (ADRs) to LAs are neurological (seizures) and cardiac (conduction disorders, cardiac arrests). However, little is known about other adverse drug reactions (ADRs).
Objective: The aim of this study was to characterize the safety profile of the LAs lidocaine, bupivacaine, mepivacaine, ropivacaine and levobupivacaine.
Study design: We studied ADRs occurring between 1995 and 2006 reported to the French Pharmacovigilance System.
Main outcome measure: For each ADR, we noted type of LA, type of ADR, its seriousness and the causality assessment score.
Results: We identified 727 reports (corresponding to 0.3% of patients in the database) in which LA was suspected as the cause of 1157 different ADRs. Sixty-one patients (8.7%) were children aged <18 years. Lidocaine (36.0%) and bupivacaine (35.4%) were the LAs most often involved. The most frequently reported ADRs were failure of the block (27.7%), followed by neurological (22.1%), allergic (19.4%) and cardiovascular (15.3%) complications. Eight patients died. Spinal anaesthesia performed with bupivacaine represented 90% of failed blocks. Seizures were the most frequent neurological complications, leading to death in four cases. Twenty-two of 111 cardiovascular complications were cardiac arrest (three of which were fatal).
Conclusion: To our knowledge, this is the first analysis of safety profiles of LAs in a non-selected population, using data collected in a pharmacovigilance database. The present study confirmed the frequency and seriousness of both neurological and cardiovascular complications. Other less well documented ADRs were identified, such as spinal anaesthesia failures with bupivacaine and allergic reactions following LA injections.
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The authors acknowledge the assistance of all 31 regional centres of the French Pharmacovigilance System. They also want to thank Frédérique Martin, M.D. (Staff Anesthesiologist, Pôle d’Anesthésie Réanimation, Centre Hospitalier Universitaire Purpan, Faculté de Toulouse, Toulouse, France) for the linguistic consultation and correction of this article, and Philippe Cavalié (Agence Française de Sécurité Sanitaire des Produits de Santé, Saint Denis, France) for his valuable contribution. No funding was provided for the conduct of the study or preparation of the paper. There were no relevant conflicts of interest for any of the authors.
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