Local anaesthetic drugs: adverse effects as reported through the ADROIT system in the UK.

PURPOSE: Adverse drug reactions (ADRs) to local anaesthetic drugs are reported voluntarily through the Adverse Drug Reporting On Line Tracking system (ADROIT). We aimed to determine hazards associated with drugs commonly used in anaesthesia including ropivacaine and levobupivacaine.

METHODS

The ADROIT database was queried for all ADRs to local anaesthetics used in anaesthesia and surgery between 1967 and 2005. Details of age, sex, suspect drug, date and reaction details were analysed.

RESULTS

There were 985 reports analysed, 797 for lidocaine, 160 for bupivacaine, 16 for ropivacaine and 12 for levobupivacaine. The female to male ratio was 1.6:1 and age was not a factor determining the frequency of reactions. A vasoconstrictor was included in the lidocaine formulation in 27% of reports. When methylprednisolone (Depo-Medrone) or prilocaine (as EMLA cream) were used in combination with lidocaine, the frequency of allergic reports increased significantly (p < 0.0001). Levobupivacaine demonstrated a hazard signal for cardiovascular symptoms. Fatality rate within the reports was higher for bupivacaine (11%) than for lidocaine (3%).

CONCLUSIONS

The patient's age and sex were not found to influence the type of reactions reported. Lidocaine with methylprednisolone or prilocaine (as EMLA(TM) cream) generated the largest number of reports of allergic phenomena. Fatalities were most frequently reported in association with bupivacaine.