Evaluating Ubrogepant-related adverse events using the FDA adverse event reporting system

ABSTRACT

Background

Migraine has a high prevalence in the population and accounts for 12% of primary headaches. Ubrogepant is used for the treatment of acute migraine, and although some clinical trials have demonstrated the safety of Ubrogepant, its long-term safety in a large sample of the population remains to be investigated.

Methods

We collected data from the US Food and Drug Administration Adverse Event Reporting System (FAERS) database. We used reporting odds ratio (ROR), the proportional reporting ratio (PRR), the information component (IC) and the empirical Bayes geometric mean (EBGM) to evaluate Ubrogepant-induced adverse events (AEs).

Results

We screened out 2,067 reports of Ubrogepant as primary suspected (PS) and 6,190 reports of Ubrogepant-induced AEs as PS. Our results showed that Ubrogepant-induced AEs targeted 4 system organ classes (SOCs), detected 32 Preferred terms (PTs) signals in 9 SOCs, including common Ubrogepant label consistent with Migraine, Nausea, Somnolence, Paraesthesia oral and Dizziness, It also includes the AEs of Hemiparesis, Mental impairment, Dysstasia, Tinnitus, Chest pain, Cold sweat, Neck pain, etc. that have not been demonstrated in previous studies.

Conclusions

Our study identified new AEs that have not been reported, which provides a new guidance to deepen the comprehension of the safety of Ubrogepant.

KEYWORDS:

• Ubrogepant
• Food and Drug Administration Adverse Event Reporting System
• adverse event
• pharmacovigilance
• system organ classe

Declaration of interests

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

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

Author contribution statement

BC and GX contributed to the conception of the study. YM, ZS and HC performed the SAS software and contributed significantly to the analysis and manuscript preparation. BC, GX, YM, ZS, YH and HC performed the data analyses and wrote the manuscript. YH helped to perform the analysis and contributed constructive discussions.

Acknowledgments

We would like to express our gratitude to Dr. Zhao and his official account “Bioinformatics assistant”.

Data availability statement

Publicly available datasets were analyzed in this study. This data can be found here: [https://fis.fda.gov/extensions/FPD-QDE-FAERS/FPD-QDE-FAERS.html].

Supplemental data

Supplemental data for this article can be accessed online at https://doi.org/10.1080/14740338.2023.2251390.

Additional information

Funding

The study was funded by Ningbo Clinical Research Center for Otolaryngology-Head and Neck Disease [No.2022L005]; Ningbo medical and health brand discipline [No.PPXK2018-02]; Ningbo Natural Science Foundation [2021J290]; Ningbo Clinical Research Center for Otolaryngology-Head and Neck Disease [No.2022L005], all of which are in China.