Adverse drug reactions to local anaesthetics: a review of the French pharmacovigilance database.
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.


METHODS
We studied ADRs occurring between 1995 and 2006 reported to the French Pharmacovigilance System.


METHODS
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).


CONCLUSIONS
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.
Fuzier
Régis
R
Laboratoire de Pharmacologie Médicale et Clinique, Unité de Pharmacoépidémiologie, EA 3696, Université de Toulouse, Faculté de Médecine, and Service de Pharmacologie Clinique, Centre Hospitalier Universitaire de Toulouse, Toulouse, France.
Lapeyre-Mestre
Maryse
M
Samii
Kamran
K
Montastruc
Jean-Louis
JL
D000293:Adolescent; D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems / Q000706:statistics & numerical data*; D000368:Aged; D000369:Aged, 80 and over; D000779:Anesthetics, Local / Q000009:adverse effects*; D002648:Child; D002675:Child, Preschool; D016208:Databases, Factual; D005260:Female; D005602:France / Q000453:epidemiology; D006323:Heart Arrest / Q000139:chemically induced* / Q000453:epidemiology; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D008875:Middle Aged; D017891:Pharmacoepidemiology; D011159:Population Surveillance; D011358:Product Surveillance, Postmarketing; D012640:Seizures / Q000139:chemically induced* / Q000453:epidemiology
D000779:Anesthetics, Local