Analysis of drug-induced posterior reversible encephalopathy syndrome using the food and drug administration adverse drug events reporting system database

ABSTRACT

Objective

In this retrospective pharmacovigilance study, we gathered data on drug-induced posterior reversible encephalopathy syndrome (PRES). Our goal was to identify the primary suspect drugs in PRES by analyzing the Food and Drug Administration Adverse Events Reporting System (FAERS) database.

Methods

We identified and analyzed reports of PRES listed in the FAERS database between 2004 and 2021. Using the reporting odds ratio and 95% confidence interval, we evaluated the safety signals for each of the drugs associated with PRES.

Results

We reviewed 11,077 reports of adverse events corresponding to PRES. The primary suspect drug categories were antineoplastics, immunosuppressants, and glucocorticoids. PRES was 24.77% more likely to occur in females than in males. Drug-induced PRES usually occurs in individuals with cancer, those who have undergone an organ/stem cell transplant, and those with autoimmune conditions.

Conclusion

Our results show that the drugs most commonly suspected to cause PRES were antineoplastics, immunosuppressants, and glucocorticoids. Future studies are needed to illuminate the pathophysiological alterations that underlie PRES. In the meantime, prescribers and patients should be made aware of the potential risks of PRES associated with pharmaceutical therapy, and the summaries of product characteristics for individual drugs should be updated to include this information.

KEYWORDS:

• Drug-induced posterior reversible encephalopathy syndrome
• FAERS
• pharmacovigilance
• adverse drug reaction
• PRES

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.

Data availability statement

Data supporting the results of this study are available upon request from the Food and Drug Administration or through the OpenVigil platform. [http://openvigil.sourceforge.net].

Ethics approval statement

Patient consent was waived because the study is based on anonymous data that can be downloaded from a publicly available source.

Additional information

Funding

This study was supported by Guangxi Promotion and Application Project grant for Health Appropriate Technology Development Promotion and Application Project [S2018082], Guangxi Clinical Key Specialty Construction Project (2020) and Guangxi Medical and Health Key Discipline Construction Project (2022).