A real-world analysis of safety profile of selexipag by using FDA adverse Event Reporting System (FAERS)

ABSTRACT

Background

The current investigation sought to conduct a real-world analysis of adverse events (AEs) associated with selexipag by utilizing data from the Food and Drug Administration Adverse Event Reporting System (FAERS).

Methods

The Reporting Odds Ratios (ROR) and the Medicines Healthcare Products Regulatory Agency (MHRA) method were employed to assess the potential associations between selexipag and AEs. Case reports of adverse drug reaction (ADR) related to selexipag were systematically sourced from PubMed, Embase, and Web of Science databases.

Results

Our analysis identified 281 Preferred Terms (PTs) signals across 20 System Organ Classes (SOCs) were found to meet the screening threshold. The most common AEs were consistent with instructions, randomized controlled trials (RCTs), and case reports. Of significant note, unexpected AEs principally target SOCs of infections and infestations, blood and lymphatic system, renal and urinary disorders, hepatobiliary disorders, including pneumonia, metapneumovirus, decreased hemoglobin. transfusion, iron-deficiency anemia, dialysis hypotension, abnormal creatinine renal clearance, liver function test increased, hepatic function abnormal, hepatic enzyme increased. Within the pediatric population, unexpected signals such as pyrexia, pneumonia, and intussusception necessitate special precautionary measures.

Conclusions

The findings contribute valuable insights to clinical practice, reinforcing the importance of vigilant monitoring, and can be instrumental in guiding both therapeutic applications and safety assessments of this particular medication.

KEYWORDS:

• Selexipag
• adverse events
• case reports
• safety profile
• FAERS

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

A reviewer on this manuscript is the principle investigator for an investigator-initiated trial, and the local principle investigator for a sponsor-initiated trial by Janssen. The remaining reviewers have no other relevant financial relationships or otherwise to disclose.

Author contribution statement

Study concept and design: Sanhua Zhan, Jie Zhao. Data curation: Jie Zhao, Mei Wang. Analysis and interpretation of the data: Jie Zhao, Qing Yu, Yi Yang. Methodology: Sanhua Zhan, Jie Zhao. Writing original draft: Jie Zhao. All the authors read and approved the final manuscript and agree to be accountable for all aspects of the work.

Acknowledgments

We would like to thank the Food and Drug Administration Adverse Event Reporting System.

Supplementary material

Supplemental data for this article can be accessed online at https://doi.org/10.1080/14740338.2023.2290633

Data availability statement

The data that support the findings of this study are available in FAERS at: https://fis.fda.gov/sense/app/95239e26-e0be-42d9-a960-9a5f7f1c25ee/sheet/33a0f68e-845c-48e2-bc81-8141c6aaf772/state/analysis and https://fis.fda.gov/extensions/FPD-QDE-FAERS/FPD- QDE-FAERS.html.

Additional information

Funding

This paper was funded by Natural Science Key Project of Bengbu Medical College [2023byzd039].