Central serous chorioretinopathy secondary to drugs: a real-world pharmacovigilance study of the FDA adverse event reporting system (FAERS)

ABSTRACT

Background

The objective of this study was to evaluate the reporting associations between Central serous chorioretinopathy (CSCR) and many available drugs using FAERS.

Research design and methods

FAERS reports from 2004 to 2023 were included in the study. The Medical Dictionary for Regulatory Activities (MedDRA) was used to identify CSCR cases. Reporting odds ratios (RORs) and corresponding 95% confidence intervals (CIs) for the reporting associations between available drugs and CSCR were calculated. A reporting association was considered statistically significant when the lower limit of the 95% CI was > 1.0.

Results

There were1002 reports of 110 drugs with suspected drug-associated CSCR based on the ‘primary suspects’ role code in the FAERS database found to have statistically significant signals. Among the top 20 ROR drugs, the most frequently reported drugs were dermatological drugs (ATC:D, 210 cases, 64.41%), followed by antitumor agents and immunological agents (ATC:L,77 cases, 23.62%), Systemic Hormonal Preparations, Excl. Sex hormones and Insulins (ATC:H, 19 cases, 5.80%) and sensory organ drugs (ATC:S, 9 cases, 2.76%). The top 3 drugs associated with CSCR were Prednisolone (144 cases, 44.17%), Fluticasone (29 cases, 8.90%), and Methylprednisolone (27 cases, 8.28%).

Conclusions

This is the first real-world study using FAERS database to investigate drug induced CSCR. Clinicians and pharmacist must keep in mind CSCR is a serious ocular complication associated with glucocorticoids, tyrosine kinase receptor inhibitor, and other drugs that can cause CSCR.

KEYWORDS:

• CSCR secondary to drugs
• FAERS
• pharmacovigilance study
• real-world

Disclaimer

As a service to authors and researchers we are providing this version of an accepted manuscript (AM). Copyediting, typesetting, and review of the resulting proofs will be undertaken on this manuscript before final publication of the Version of Record (VoR). During production and pre-press, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal relate to these versions also.

Declaration of Interest

The authors have no conflicts of interest that are directly relevant to the content of this study, and we declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Reviewer disclosures

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

Ethical approval

All data used in the study are secondhand, coming from public databases. Ethical approval was not required.

Data Availability Statement

The original contributions presented in the study are included in the article, further inquiries can be directed to the corresponding authors.

Authors contributions

L Huang, X Zhang and C Zhang were involved in the conception and design; C Zhang, X Ren and J Huang were involved in the analysis and interpretation of the data; C Zhang wrote the draft of the paper and L Huang and X Zhang revised it critically for intellectual content. All authors agree to be accountable for all aspects of the work.

Additional information

Funding

This paper was not funded.