Ubrogepant and rimegepant: signal detection using spontaneous reports of adverse events from the Food and Drug Administration Adverse Event Reporting System

ABSTRACT

Background

In this study, we fill this gap in knowledge by updating the safety profile of ubrogepant and rimegepant via disproportionality analysis in the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS), a US-based database registering spontaneous reports.

Research design and methods

ASCII files of quarterly extraction of FAERS data were downloaded from the FDA website up to the 3^rd quarter (Q3) of 2021 (last accessed 03/02/2022). Disproportionality analysis was done using the Reporting Odds Ratio (ROR) as a disproportionality measure. RORs of all AEs related to ubrogepant and rimegepant in FAERS were calculated in comparison with those related to erenumab. Drug-event pairs with a frequency ≤ 2, were removed according to European Medicine Agency (EMA)’s procedures.

Results

In total, 2010 and 3691 individual case safety reports (ICSRs) recorded in FAERS reported ubrogepant and rimegepant, respectively, as suspect drugs. Ten disproportionality signals for ubrogepant and 25 disproportionality signals for rimegepant were identified; these were mostly related to psychiatric, neurological, gastrointestinal, skin, vascular, and infectious type of adverse events.

Conclusions

New safety aspects related to the treatment of ubrogepant and rimegepant using disproportionality analysis from spontaneous reporting databases were identified. Further studies are needed to confirm these findings.

KEYWORDS:

• Pharmacovigilance
• FAERS
• migraine
• rimegepant
• ubrogepant
• erenumab

Acknowledgments

V. Battini is enrolled in Ph.D. in Experimental and Clinical Pharmacological Sciences, Università degli Studi di Milano, which supports her fellowship.

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

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

Author contribution statement

V. Battini and M. Sessa conceived and designed the study. V. Battini and M. Sessa designed and supervised the research and analyzed the data. V. Battini wrote the original draft and C. Carnovale, E. Clementi, and M. Sessa reviewed and edited with inputs from all authors. V. Battini, C. Carnovale, E. Clementi, and M. Sessa participated in the interpretation of data, revised and approved the final article as submitted.

Ethics approval

No ethical approval is required for studies using publicly available data from FAERS.

Data availability statement

The data that support the findings of this study are available from the corresponding author, V B, upon reasonable request.

Code availability

Code is available from the corresponding author upon reasonable request.

Abbreviation list

AE	=	adverse events
CGRP	=	calcitonin gene-related peptide
EMA	=	European Medicine Agency
FAERS	=	Food and Drug Administration Adverse Event Reporting System
FDA	=	Food and Drug Administration
ICSRs	=	individual case safety reports
MedDRA	=	Medical Dictionary for Regulatory Activities
NLP	=	Natural Language Processing
ROR	=	Reporting Odds Ratio
SmPC	=	Summary of the Product Characteristics

Additional information

Funding

This paper was not funded.