Drug-related adverse events in people with dementia – Statistical data from the FDA adverse event reporting system

Abstract

Background

People with dementia (PwDs) are particularly vulnerable to adverse events (AEs). Recognising and understanding AEs is essential to improve patient safety.

Objective

This study analysed FAERS data from the past decade to identify AE symptom characteristics in PwDs.

Methods

The FAERS data (2014–2024) was reviewed, extracting reports with dementia as an indication. The reports’ features were described and analysed, including k-means clustering to identify patterns.

Results

From 2014 to 2024, 20,913 reports related to PwDs were extracted. Consumers and health care professionals were the most common reporters. Regarding patient outcomes, 38.7% of records reported hospitalisation and 10.6% reported death. The most frequently reported AEs were death, aggression, and bradycardia. Cholinesterase inhibitors (ChEIs), antipsychotics, and anticonvulsants were frequently associated with nervous system and psychiatric disorders. K-means clustering identified four groups, with older PwDs on ChEIs experiencing cardiovascular issues, while younger PwDs on antipsychotics faced higher mortality, drug ineffectiveness, and fall risks.

Conclusions

Many symptoms observed in PwDs are often attributed to ageing or disease progression, potentially obscuring their link to drug-related causes. Enhancing AE reporting across healthcare roles, promoting public awareness, conducting regular medication reviews, and providing training in early detection are vital for the safe management of dementia.