OBJECTIVES

Diabetes insipidus disorder of salt and water metabolism marked by intense thirst and heavy urination. Sevoflurane, also called Fluoromethyl, is an ether inhalation anaesthetic agent used for the induction and maintenance of general anaesthesia. This study aims to quantify the risk of Diabetes insipidus associated with Sevoflurane using disproportionality analysis of USFDA Adverse Event Reporting System (FAERS).

METHODS

An analysis was performed using publicly available FAERS data. Signal strength was calculated by Reporting odds ratios (RORs) and Proportional reporting ratios (PRRs) with 95% confidence intervals (CIs). A value of ROR lower limit >1 and PRR >2, minimum 3 cases and chi square <4 indicates an association between drug and the adverse events.

RESULTS

FAERS database had a total of 1454 reports for Diabetes Insipidus. Amongst which, 35(2.4%) reports were associated with sevoflurane. sevoflurane associated diabetes insipidus was found to have a signal strength of ROR:44.652(27.199-73.306) and PRR:44.447(27.136-72.801). sevoflurane without concomitant drugs associated with diabetes insipidus was found to have a signal strength of ROR:61.21486(43.72279-85.70493) and PRR:60.79081. The minimum and maximum age reported was found to be 15years and 71years respectively with signal strength of ROR:8.791; PRR:8.769 for paediatrics, ROR:72.021; PRR71.178 for adults. Diabetes insipidus was mostly reported in females (48.57%) compared to males (34.29%) with the signal strength of ROR:52.809; PRR:52.567 and ROR:52.078; PRR:51.707 respectively.

CONCLUSIONS

The present showed an associated between Sevoflurane and Diabetes insipidus, while this adverse event is not listed in the pre-clinical trial or post-marketing data. Although a causal relation cannot be definitively proved, the number of cases reported suggests that there might be an association. Increased awareness of this risk among both prescribers and patients may help mitigate the number and severity of these adverse events.