PhD Student University of Cincinnati Cincinnati, United States
Background: The safety of injectable Ketamine has not been assessed in the real world despite its long use in clinical settings.
Objective: To estimate and characterize adverse drug reactions (ADRs) associated ketamine reported in the FDA Adverse Event Reporting System (FAERS).
Methods: FAERS was combined with Adverse Event Reporting System (AERS) to include all reports from 2004 to 2021 using standardized methods and validation process. Retrospective descriptive analysis of all major reported ADRs and outcomes. The total numbers of ADRs reports, cases, adverse reactions and outcomes were estimated. Preliminary
Results: Total of 163 reports for injectable ketamine compared to 30 reports for esketamine.25% of the reports were in 2018 quarter3. Female were 20%. product used for unknown indication was the most common indications, around 50%. 7% reported depression as the reason for indication. The United States had the highest rate of reports with over 45%, followed by Taiwan. Majority of the outcomes were documented as other serious which represent around 75% of the total outcomes, while hospitalization comes second and represent approximately 41% of the total outcomes, and around 20% of the outcomes were classified as life-threatening. Death less than 10% and around only 2% of outcomes required intervention and finally, only 1% of the outcomes were classified as a disability.
Drug abuse and urinary tract infections were the most common adverse events reported, followed by acute kidney injury. The other most common adverse events were seizures and bradycardia. Most of the ketamine indications were reported as unknown and epileptics.
Further work will include disproportional analysis to assess the association of Ketamine with ADRs. Further work is needed which include data cleaning, mapping, case reports deduplication, cleaning, and drug names Standarization utilizing RXnorm and MedDRA dictionaries for indications.
