Elmiron (Pentosan Polysulfate Sodium)

Elmiron is the brand name for pentosan polysulfate sodium, made by Janssen, a Johnson and Johnson company. It is an oral drug approved by the FDA to relieve bladder pain and discomfort from interstitial cystitis, a chronic bladder condition that mostly affects women. Many patients took it for years.

Starting around 2018, eye doctors reported a distinctive pattern of retinal damage in long-term Elmiron users. On June 16, 2020, the FDA approved a labeling change adding a warning that pigmentary changes in the retina, reported in the literature as pigmentary maculopathy, have been identified with long-term use of Elmiron. Symptoms can include difficulty reading, trouble adjusting to dim light, and blurred vision, and the damage may not reverse after stopping the drug. The label now recommends a baseline retinal exam and periodic exams during treatment.

Thousands of patients sued, alleging Janssen knew or should have known about the risk earlier and failed to warn. In December 2020, the Judicial Panel on Multidistrict Litigation centralized the federal cases as In re: Elmiron (Pentosan Polysulfate Sodium) Products Liability Litigation, MDL No. 2973, in the District of New Jersey. The company denied the allegations. Many claims have since been resolved through confidential settlements, so no public settlement fund exists to file against.

If you took Elmiron and have vision problems, ask an eye doctor about a retinal exam and keep your prescription history. Our guide to multidistrict litigation explains how cases like this are organized.