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Association Between Pentosan Polysulfate Sodium and Retinal Disorders
Gerald McGwin1,2, Paul MacLennan3, Cynthia Owsley2
1Department of Epidemiology, School of Public Health, University of Alabama at Birmingham, Birmingham.
JAMA Ophthalmology
|November 18, 2021
Summary
Pentosan polysulfate sodium (PPS) use is linked to a higher risk of maculopathy, a serious retinal condition. Further research is needed to confirm this association and guide clinical practice.
Area of Science:
- Ophthalmology
- Pharmacovigilance
- Toxicology
Background:
- Case series suggest a link between pentosan polysulfate sodium (PPS) and a specific maculopathy.
- Previous observational studies on this association have produced inconclusive results.
Purpose of the Study:
- To investigate the association between pentosan polysulfate sodium (PPS) exposure and the occurrence of maculopathy.
- To quantify the risk of maculopathy in patients using PPS.
Main Methods:
- A disproportionality analysis was performed using the US FDA Adverse Event Reporting System (FAERS) database.
- Data spanned from January 2013 to June 2020, comparing PPS adverse event reports with those of drugs for similar indications (e.g., interstitial cystitis).
- Retinal adverse events were identified using a standardized MedDRA query.
Main Results:
- The proportion of macular events was higher in PPS users compared to users of other drugs for similar conditions (PRR 1.21).
- Specific retinal conditions, including maculopathy, macular degeneration, retinal dystrophy, injury, and toxicity, were proportionately more frequent in the PPS group.
Conclusions:
- This study provides further evidence suggesting an association between PPS use and an increased risk of maculopathy.
- Future studies should screen for pre-existing retinal abnormalities before initiating PPS treatment to strengthen the evidence base.
