A Real-World Data Analysis of Adverse Drug Reactions Associated with Neuroprotective Agents: Insights from WHO-VigiAccess

Cerebrolysin and Citicoline show higher risks of adverse drug reactions, particularly affecting the musculoskeletal and neurological systems, necessitating careful monitoring in clinical practice.

Summary and findings

This study analyzed adverse drug reactions (ADRs) associated with neuroprotective agents, specifically focusing on Cerebrolysin, using the WHO-VigiAccess database. A total of 379,061 ADR reports were examined, with Cerebrolysin showing a high frequency of ADRs primarily affecting musculoskeletal and neurological systems. The findings suggest a need for close clinical monitoring of patients using these agents.

Abstract

<title>Abstract</title> <p>Introduction: Sensorineural hearing loss (SNHL) is a common sensory disorder characterized by auditory nerve damage and cochlear dysfunction, often driven by oxidative stress, excitotoxicity, and neuroinflammation. Neuroprotective agents such as Cerebrolysin, Citicoline, Flunarizine, and Mecobalamin have demonstrated efficacy in addressing these mechanisms by reducing oxidative damage, modulating calcium overload, and promoting neuronal repair. Despite their therapeutic potential for SNHL and related neurological conditions, the real-world safety profiles of these drugs remain unclear. This study aims to evaluate and compare the adverse drug reactions (ADRs) associated with these agents using the WHO-VigiAccess database. Methods A descriptive, retrospective study was conducted using ADR data from the WHO-VigiAccess database. Reports for four neuroprotective drugs were analyzed for demographics, System Organ Class (SOC) distributions, and ADR frequencies. Statistical methods including Reporting Odds Ratio (RoR), Proportional Reporting Ratio (PRR), Principal Component Analysis (PCA), and K-means clustering were applied to identify risk patterns and classify safety profiles. Results Among 379,061 ADR reports, Cerebrolysin (132,476) and Citicoline (123,451) exhibited the highest ADR frequencies, primarily affecting musculoskeletal, neurological, and gastrointestinal systems. Mecobalamin (68,904) was associated with hematological risks (leukopenia, thrombocytopenia), while Flunarizine (54,230) demonstrated the lowest ADR frequency, with sedation and gastrointestinal complaints being predominant. PCA and K-means clustering categorized Cerebrolysin and Citicoline as high-risk drugs, whereas Flunarizine and Mecobalamin were classified as moderate-risk drugs with relatively safer profiles. Conclusion Cerebrolysin and Citicoline exhibit higher ADR risks, particularly musculoskeletal and neurological events, warranting close clinical monitoring. In contrast, Flunarizine and Mecobalamin present safer alternatives for long-term use. These findings underscore the need for individualized therapy and proactive risk management in using neuroprotective agents for SNHL treatment.</p>

Elsewhere in the Cerebrolysin corpus