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  • Retinal complications reported following use of pentosan polysulfate

    Retina/Vitreous

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    Review of: Association between pentosan polysulfate sodium and retinal disorders

    McGwin G Jr, MacLennan P, Owsley C. JAMA Ophthalmology, January 2022

    Investigators analyzed data entered in the US FDA Adverse Event Reporting System (US FAERS) between January 2013 and June 2020 to evaluate spontaneous reports of retinal complications linked to pentosan polysulfate sodium (PPS) use.

    Study design

    The study compared reports associated with PPS (2775) with reports linked to other drugs used for interstitial cystitis and bladder pain (6833), and then evaluated the proportion and number of macular events for PPS compared with the other drugs. Reported adverse events included retinal disorders with damage attributable to blood supply blockage, toxins, nutritional deficiencies, and diseases affecting the retina such as macular degeneration (AMD).

    Outcomes

    There was a greater percentage of women in the PPS group (70.9%) than in the other-drugs group (59.1%). An increased proportion of adverse events for any macular event, relative to all other events, was noted in patients given PPS compared with patients given other drugs (proportionate reporting ratio [PRR] 1.21); similar findings were seen for maculopathy (PRR 102.19) and macular degeneration (PRR 3.28) specifically.

    Limitations

    The US FAERS database contains information voluntarily reported by patients, healthcare professionals, lawyers, and drug companies, so there is the potential for a significant number of patients to have maculopathy that is unreported or not identified in the database.

    Clinical significance

    Maculopathy associated with PPS is documented in the literature and has the potential to cause severe irreversible vision loss. In this study, these adverse effects were more prevalent with patients taking PPS than in patients taking other medications for bladder pain. Further data from additional studies, including observational studies of people with normal fundi, are needed.