Long-Term Elmiron Use Caused Pigmentary Maculopathy, Lawsuit Alleges

A North Carolina woman indicates she developed permanent vision problems Elmiron, alleging in a recently filed lawsuit that side effects of the interstitial cystitis drug resulted in a form of retinal damage known as pigmentary maculopathy.

In a complaint (PDF) filed in the U.S. District Court for the Middle District of North Carolina on August 7, Tomme Echerd claims Johnson & Johnson, Janssen Pharmaceuticals, Ortho-McNeil Pharmaceuticals and Teva Pharmaceuticals withheld information from users and the medical community about the risks associated with long-term use of Elmiron.

Echerd was diagnosed with interstitial cystitis in 1998 or 1999, and was prescribed the medication Elmiron, which she used until earlier this year. However, she began experiencing vision problems in April 2019, including trouble with night vision, difficulty adapting to darkness, and loss of central vision. Echerd was eventually diagnosed with pentosan polysulfate maculopathy; a condition that independent researchers have recently linked to use of the treatment.

Elmiron (pentosan polysulfate sodium or PPS) is the only approved drug for interstitial cystitis, also commonly referred to as “painful bladder syndrome”, and has been marketed as safe and effective since 1996. Although concerns existed for years among vision specialists about the risk of retina damage, Elmiron vision warnings were not added to the drug label in the U.S. until June 2020.

The label update came after a series of independent studies and case reports published in recent years highlighted cases involving visual injury and pigmentary changes in the retina among long-term users of Elmiron. The drug has been linked to reports in which users to experienced difficulty adjusting in dark light, problems reading, centralized dark spots and other complications, yet information about the risk of pigmentary maculpathy was withheld from the drug warning label for years.

“Due to the absence of any warning by Defendants of the risks posed by Elmiron, Plaintiff was unaware that use of Elmiron could result in retina damage and vision impairment,” the lawsuit states. “This danger was also unknown to Plaintiff’s healthcare providers or the general public due to Defendants’ failure to warn.”

Since most ophthalmologists were previously unaware of the Elmiron vision damage risks associated with the bladder drug, a growing number of long-term Elmiron users are just now learning that they may have been previously misdiagnosed with other retinal diseases, such as macular degeneration, pattern dystrophy and other problems, which were actually caused by the toxic effects of the drug on the eyes.

As Elmiron lawyers continue to review and file claims in the coming months and years, it is expected that hundreds of similar complaints may be brought in state and federal courts nationwide.