Pharmacoepidemiol Risk Manage.  2023 Mar;15(1):51-61. 10.56142/perm.22.0017.

Patterns of Adverse Event Reporting for Long- and Short-Acting Benzodiazepines

• Lee JW
• Jung YS
• You SH
• Nam DR
• Jung SY

• KMID: 2544377
• DOI: http://doi.org/10.56142/perm.22.0017

Abstract

Objective
To assess the patterns of adverse event reports including long-acting benzodiazepines compared with short-acting.
Methods
Among the individual case safety reports (ICSRs) reported to KIDS-KAERS database (KIDS-KD) between 2016 and 2020, reports for benzodiazepines were selected. Benzodiazepines were categorized into two groups (long-acting and short-acting) based on their elimination half-life of 24 hours. We compared distribution of reported adverse events following long-acting compared by short-acting benzodiazepines. For comparing patterns of reported adverse events, we adopted the criteria of signal detection: proportional reporting ratio (PRR, PRR ≥ 2, cases ≥ 3, χ² ≥ 4), reporting odds ratio (ROR, ROR ≥ 2, cases ≥ 3, χ² ≥ 4), and log of information component (IC, IC_low > 0).
Results
Among the total of 3,047,435 ICSRs in the KIDS-KD, the number of ICSRs for long-acting benzodiazepines users was 9,490 (0.3%) and shortacting benzodiazepines users was 21,179 (0.7%). The average age was 59 years old. The number of patients aged over 65 years old for long-acting and short-acting benzodiazepines was 3,687 (38.9%) and 7,953 (37.6%), respectively. Adverse events such as delusion (PRR, 2.8), gait abnormal (PRR, 2.6), hypotonia (PRR, 2.6), migraine (PRR, 5.6), or else were reported significantly higher in long-acting benzodiazepines.
Conclusion
We confirmed that adverse events including gait abnormal and delusion showed higher reporting ratios in long-acting benzodiazepines compared with short-acting benzodiazepines. Therefore, caution is required when using longacting benzodiazepines. (PeRM 2023;15:51-61)

Keyword

Benzodiazepines; Half-life; Drug-related side effects and adverse reactions