Exploring the Top 50 Drugs Associated with Restless Legs Syndrome Based on the FDA Data from 2004 to 2024

Area of Science:

• Pharmacovigilance
• Clinical Pharmacology
• Drug Safety

Background:

• Drug-associated restless legs syndrome (RLS) significantly affects patient quality of life.
• Identifying common causative agents is crucial for patient safety and clinical management.

Purpose of the Study:

• To identify the 50 most frequently reported drugs associated with RLS in the FDA Adverse Event Reporting System (FAERS) database.
• To analyze the epidemiological characteristics and risk factors of drug-associated RLS.

Main Methods:

• Extracted RLS-related adverse drug event reports from FAERS (Q1 2004 - Q3 2024).
• Compiled a list of the 50 most common drugs and employed four risk signal detection methods.
• Utilized logistic regression for risk factor analysis and Weibull Shape Parameter (WSP) test for time-to-onset (TTO).

Main Results:

• 16,410 RLS reports were analyzed; sodium oxybate was most frequent (3.9%).
• Nervous system medications accounted for 31.3% of cases; 27 of 50 drugs showed valid risk signals.
• Risk factors included younger age, higher weight, female gender, and specific drugs; most drugs had early onset patterns.

Conclusions:

• Highlights drugs potentially linked to drug-associated RLS.
• Emphasizes the need for clinicians to consider these drug risks in patient care.
• Suggests further investigation into the early onset patterns of drug-induced RLS.