A real-world pharmacovigilance study of neuroleptic malignant syndrome based on FDA adverse event reporting system

Abstract

Background: Neuroleptic malignant syndrome (NMS) is a rare but potentially life-threatening adverse drug reaction. This study aims to identify the most prevalent drugs associated with the risk of NMS according to the United States Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database.

Methods: Analyses were performed using data from the FAERS database from January 2004 to June 2024. Single-drug signals were evaluated using the reporting odds ratio (ROR), proportional reporting ratio (PRR), information component (IC), and empirical Bayes geometric mean (EBGM). Meanwhile, comparisons were performed with drug labels. Additionally, subgroup analysis was conducted, focusing on adverse drug reaction signals among populations of different genders and age groups.

Results: A total of 10,433 adverse event reports related to NMS were identified, with the top 50 drugs ranked by ROR mainly involving antipsychotics (18, 36%), antiparkinson drugs (10, 20%), antidepressants (7, 14%), antiepileptics (3, 6%), anxiolytics (3, 6%), as well as hypnotics and sedatives (3, 6%). NMS is more prevalent in males (5,713, 54.76%). Among the top 20 drugs with the strongest signal strength, the pediatric group showed an additional presence of benzodiazepines and antiepileptic drugs compared to the adult group.

Conclusion: The current comprehensive pharmacovigilance study identified more drugs associated with NMS and provides references to clinicians for clinical practice. Also, further research is needed to investigate the causal relationship between these drugs and NMS.

Keywords: FAERS; adverse event reports; disproportionality analysis; neuroleptic malignant syndrome; pharmacovigilance.