Pigmentary Maculopathy

Pigmentary maculopathy is a disease of the macula, the small central part of the retina responsible for sharp, detailed vision. Clumps and changes in the retina's pigment appear on eye exams and imaging. People may notice trouble reading, difficulty adjusting to dim light, blurred or distorted central vision, or dark spots. It can look similar to age-related macular degeneration or inherited retinal diseases, which is why it can be misdiagnosed.

The term became widely known because of Elmiron (pentosan polysulfate sodium), a prescription drug for the bladder condition interstitial cystitis. Eye doctors reported a distinctive pattern of retinal damage in long-term users, and the label was changed. Elmiron's prescribing information now warns that pigmentary changes in the retina, reported as pigmentary maculopathy, have been identified with long-term use, and that although most cases occurred after 3 years of use or longer, cases have been seen with shorter use. The Medication Guide says the changes may continue even after the drug is stopped, and recommends eye exams.

That label change set off thousands of lawsuits claiming Janssen, the maker, should have warned years earlier. Federal cases were consolidated in multidistrict litigation in New Jersey. A claim generally needs records showing Elmiron use and a diagnosis from an eye specialist, often supported by retinal imaging.

If you took Elmiron, an eye exam that includes retinal imaging is the key first step, both for your health and for any claim. For how drug cases are organized, see what is MDL and class action vs. mass tort. This page is general information, not medical advice.