Nieraj Jain was puzzled by the patient sitting quietly in front of him. The woman, in her 60s, was losing her eyesight; that much was clear. Her vision was blurred, and she was having increasing difficulty seeing at night and in bright sunlight. Less obvious was the cause. A retinal specialist and surgeon at Emory University in Georgia, Jain pored over specialized scans of her eye and saw odd patches of pigment on her retina — patches that didn’t fit with any known diagnosis.
A fleeting memory pulled him up short; hadn’t he seen another patient a few months before with a similar finding? Combing through patient records, Jain dug up five more patients at Emory with the same puzzling retinal changes. All were going blind — and all happened to be taking Elmiron, a drug for a bladder condition called interstitial cystitis. In 2018, Jain and his colleagues published their findings about this new cause of blindness, dubbing it “pigmentary maculopathy.”
Meanwhile, gastroenterologists at Emory and other institutions were uncovering another troubling finding about Elmiron: Some patients on the drug were being diagnosed with colitis, a chronic inflammatory bowel disease with potentially life-threatening complications.
According to a government database analyzed by The Lever and the McGraw Center for Business Journalism at CUNY’s Newmark Graduate School of Journalism, by the end of 2024, hundreds of patients on Elmiron had suffered vision loss or blindness. Others taking the drug were even more unlucky. Dozens of patient deaths associated with Elmiron were reported to the Food and Drug Administration (FDA), and 45 patients were hospitalized with severe colitis.
Another problem? There’s no good evidence that Elmiron works.
When the government approved Elmiron in 1996, the manufacturer provided close to zero data that the drug effectively treated interstitial cystitis. Regulators allowed Elmiron on the market only on the proviso that the company conduct a second study to determine if it worked. It would take 18 years for the various companies that bought and sold the drug’s license to produce that study — and it proved to be a resounding bust. Patients who took Elmiron did no better than those given a sugar pill. (Janssen, which manufactures Elmiron, did not respond to repeated requests for comment.)