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Important Safety Information on ELMIRON (pentosan polysulfate sodium) and the Risk of Pigmentary Maculopathy – Janssen Inc.

Cases of pigmentary maculopathy have been reported with long-term use of ELMIRON. These changes may be irreversible, and retinal and vision changes may progress even after cessation of therapy. This medicine is usually used for urinary symptoms and pain associated with interstitial cystitis, a condition that presents with painful and frequent urination. HMC