Safety profile of lasmiditan: a retrospective post-marketing pharmacovigilance study based on the real-world data of FAERS database

ABSTRACT

Background

Lasmiditan offers a promising option for the treatment of migraines, particularly for individuals with cardiovascular concerns. It is crucial to gather comprehensive safety information of lasmiditan through large-scale post market monitoring.

Research design and methods

This study assessed the safety profile of lasmiditan based on real-world data of FDA Adverse Event Reporting System (FAERS) database. Four disproportionality analysis methods were applied to mining the significant signals. The differences in adverse event signals among different subgroups were investigated concerning race, sex, age, weight, dose, and concomitant drug.

Results

A total of 820 reports and 1,661 adverse events with lasmiditan as the primary suspected drug were identified. Two new adverse event signals related to nervous system disorders emerged. Females and males were more likely to develop paresthesia and dizziness, respectively. Most common adverse events were more likely to occur in the elderly patients and at high doses.

Conclusions

It is essential to be vigilant about the relation of potential nervous system disorders with lasmiditan. The importance of heightened clinical vigilance regarding paresthesia in females and dizziness in males was underscored. Additionally, it is advised to administer a lower initial dose for elderly patients.

KEYWORDS:

• Post-marketing safety
• lasmiditan
• adverse event
• disproportionality analysis
• pharmacovigilance

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.

Reviewer disclosures

One reviewer was employed by Lundbeck in the past two years. The remaining reviewers have no other relevant financial relationships or otherwise to disclose.

Author contribution statement

Cheng Jiang and Hongrui Zhang designed the study. Xiaochen Wan, Shuohan Zhang and Cheng Jiang performed the statistical analyses. Xiaochen Wan and Shuohan Zhang wrote the first draft and interpreted the results. Cheng Jiang and Hongrui Zhang reviewed and corrected the manuscript. All authors contributed to the article and approved the submitted version. All authors agree to be accountable for all aspects of the work.

Data availability statement

The original data that support the findings of this study are available online at https://fis.fda.gov/extensions/FPD-QDE-FAERS/FPD-QDE-FAERS.html The original contributions presented in the study are included in the article. Further inquiries can be directed to the corresponding author.

Ethics statement

Ethical review and approval were waived for this study because it is based on anonymous data that can be downloaded from a publicly available source.

Additional information

Funding

This paper was funded by the Public Service Technology Research Project of Zhejiang Province [LGF22H300010], National Natural Science Foundation of China [82104383], Medical Health Science and Technology Project of Zhejiang Province [2023RC141], and State Administration of Traditional Chinese Medicine Science and Technology Department-Zhejiang Provincial Administration of Traditional Chinese Medicine Co-construction of Key Laboratory of Research on Prevention and Treatment for Depression Syndrome [GZY-ZJ-SY-2402].