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Local Anesthetics & Anesthetic Toxicity

Basic Details
Status
Complete
Last Updated
Wednesday, October 23, 2024
Original Posting Date
Health Outcome(s)
anesthetic toxicity
Purpose
Methods, Characterization, or Development
Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR
No
Study Summary

The U.S. Food and Drug Administration (FDA) used the Sentinel System to assess incidence and prevalence of medical codes associated with local anesthetic toxicity. This study specifically assessed International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes.

The results included counts and prevalence of three diagnostic ICD-9-CM codes for local anesthetic toxicity stratified by year, sex, and age group. Prevalence of local anesthetic toxicity ranged from 0 to 1.02 per 100,000 enrollees, varying by year, sex, or age group.

This exploratory study provided information to FDA on the incidence and prevalence of local anesthetic toxicity medical codes in the Sentinel Distributed Database, to better aid decisions on the use of Sentinel data for capturing local anesthetic toxicity.

Result(s) (1)
Counts and Characteristics of Local Anesthetic Toxicity