Growing evidence links pentosan polysulfate sodium, maculopathy
There is growing evidence that pentosan polysulfate sodium (PPS) is associated with an increased risk for maculopathy, according to a study published online Nov. 18 in JAMA Ophthalmology.
Gerald McGwin Jr., Ph.D., from the University of Alabama at Birmingham, and colleagues examined the association between PPS exposure and maculopathy in a disproportionality analysis conducted using the U.S. Food and Drug Administration Adverse Event Reporting System from January 2013 through June 2020. Adverse events reported for PPS (2,775 reports) were compared to adverse event reports associated with drugs taken for interstitial cystitis, cystitis, bladder disorder, or bladder pain (6,833 reports).
The researchers found that users of PPS had a higher proportion of adverse events for any macular event relative to all other events compared with individuals using other interstitial cystitis and bladder pain drugs (proportionate reporting ratio, 1.21). Compared with patients using other interstitial cystitis and bladder pain drugs, macular degeneration (0.8 versus 0.2 percent), maculopathy (3.4 versus 0.03 percent), retinal dystrophy (0.1 versus 0 percent), retinal injury (0.2 versus 0 percent), and retinal toxicity (0.1 versus 0 percent) were proportionately more common among users of PPS.
“Although individual observational studies are unable to establish cause-and-effect associations, the growing body of epidemiologic, clinical, and pathophysiologic research strengthens the interpretation that PPS use may lead to maculopathy,” the authors write.
One author disclosed receiving fees from the Cracken Law Firm PC to review published science in connection with pharmaceuticals and illnesses, but no specific payments were in connection with PPS.