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

ABSTRACT

Background

The study aims to obtain the safety profile of riluzole in the real world and provide reference for clinical drug applications.

Research design and methods

Proportional reporting ratio (PRR) was used to detect 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, Embase, and Web of Science 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.

KEYWORDS:

• Riluzole
• safety
• FAERS
• systematic review
• case reports

Declaration of Interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Author contributions

Z Sun and X Liu contributed to the conceptualization and design of the study. Z Sun and P An performed the statistical analysis. Z Sun wrote the original draft. X Liu and B Zhang contributed to manuscript revision, read, and approved the submitted version. All authors substantially contributed to the conception and design of the review article and interpreting the relevant literature and have been involved in writing the review article or revising it for intellectual content.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This paper was funded by the National High Level Hospital Clinical Research Funding (2022-PUMCH-B-059), CAMS Innovation Fund for Medical Sciences (CIFMS 2021-I2M-1-003), the Fundamental Research Funds for the Central Universities (3332021003, 2021-RW310-001), the Youth Research Fund of Peking Union Medical College Hospital (201911755) and the Research Fund of Chinese Research Hospital Association (Y2021FH-YWPJ01-106)