OBJECTIVES: Drug-drug interaction harms are difficult to assess and evidence in this field is limited. This study aims to describe the characteristics of the recipients and drugs involved in fatal drug interactions reports in the FDA Adverse Event Reporting System (FAERS). FAERS uses the Medical Dictionary for Regulatory Activities (MedDRA) Preferred Terms (PTs) -single medical concept- for classification of the adverse events.

METHODS: FAERS 2022 reports mentioning the following MedDRA PTs: Drug interaction, Inhibitory drug interaction, Potentiating drug interaction, Labelled drug-drug interaction issue, and Labelled drug-drug interaction medication error, with death as the outcome were included. The process included de-duplication and manual review of cases for categorization of the implicated drugs based on their pharmacological action.

RESULTS: From 10,202 drug interaction reports, 647 (6.34%) resulted in death. The demographic profile indicated 55.64% of these cases involved males, with sex data missing in 12%, and the mean age was 57.30 years (SD=22.1), with 22% missing age information. The average of drugs by report was 6.1(SD 10.2) and Interquartile Range (Q1-Q3: 2-7). Analysis revealed that the most frequently implicated drug families were Antithrombotics/Anticoagulants (Clopidogrel Bisulfate, Rivaroxaban), Antidepressants (Sertraline Hydrochloride, Citalopram Hydrobromide, Venlafaxine Hydrochloride), Beta-blockers (Bisoprolol/Bisoprolol Fumarate), Opioids (Fentanyl/Fentanyl Citrate, Diamorphine, Methadone Hydrochloride), and Antibiotics/Antibacterials (Sulfamethoxazole/Trimethoprim, Clarithromycin).

CONCLUSIONS: FAERS database provides crucial insights into fatal outcomes from drug interactions. Despite the high frequency of reports involving specific drug families, it's important to recognize that not all fatal adverse reactions due to drug interactions may be identified. This study underscores the complexity of assessing drug interaction harms and the necessity for further research in this critical area.