pentosan polysulfate sodium · Janssen (Johnson & Johnson) · updated June 2026
Elmiron, prescribed for interstitial cystitis (bladder pain), faces lawsuits alleging that long-term use causes pigmentary maculopathy — a form of retinal damage and vision loss.
This page is general information about ongoing litigation and FDA safety actions — not medical or legal advice, and not a statement that Elmiron caused any injury. Allegations described here are claims that have not been proven in court. Always consult a licensed professional.
Plaintiffs allege Janssen failed to warn that long-term use of Elmiron (pentosan polysulfate sodium) can cause pigmentary maculopathy, a form of retinal damage.
In 2020 the FDA added a warning about retinal pigmentary changes (maculopathy) to the Elmiron label.
As of mid-2026, roughly 600–700 cases remain in MDL 2973 (District of New Jersey) — down about two-thirds from the peak. The litigation is in a resolution phase, with Janssen settling cases since 2023.