首页 > 科研进展 > 学术交流

Real-world safety profile of riluzole: a systematic analysis of data from the FAERS database and case reports

作者:Zhuo Sun 等 日期:2023-12-18 浏览量:143

第十一届北京罕见病学术大会暨2023京津冀罕见病学术大会征文(047)

1. Department of Pharmacy, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College,

2. State Key Laboratory of Complex Severe and Rare Diseases, Peking Union Medical College Hospital

3. State Key Laboratory of Bioactive Substances and Functions of Natural Medicines, Institute of Materia Medica, Chinese Academy of Medical Sciences & Peking Union Medical College

 Zhuo Sun1,2,3, Xin Liu1,2, Pengjiao An1,2, Bo Zhang1,

Objective: To obtain the safety profile of riluzole in real world, and provide reference for clinical applications.

Methods: Proportional reporting ratio (PRR) was used to detect the riluzole adverse drug reactions(ADRs) from the data between the first quarter of 2004 and the third quarter of 2022 in the FDA adverse event reporting system database (FAERS). Case reports of riluzole published in PubMed before November 2022 were reviewed and patient’s data were extracted.

Results: FAERS analysis identified 86 ADRs. Gastrointestinal system disorders and respiratory, thoracic and mediastinal disorders account for 12 of the top 20 most frequent ADRs. Similarly, 9 of the 20 highest PRR ADRs were gastrointestinal system disorders and respiratory, thoracic and mediastinal disorders. Twenty-two published riluzole-associated cases were identified in the literature. Respiratory, thoracic and mediastinal disorders were the most commonly reported cases (n=9), followed by gastrointestinal disorders, pancreatitis (n=5).

Conclusions:

Strong ADRs between riluzole and pancreatitis were identified, which reminds clinicians to monitor patients carefully. For patients with respiratory symptoms, clinicians should pay attention to distinguish the cause of their occurrence, and take appropriate measures. Beware that riluzole may increase the risk of inflammatory reactions and inappropriate vasopressin secretion and hyponatremia due to respiratory failure.