Elmiron Led To Severe Retinal Damage, Lawsuit Alleges

A product liability and personal injury lawsuit claims the side effects of Elmiron caused a Missouri woman to suffer severe retinal damage, leaving her with permanent vision loss following long term use of the bladder drug.

The complaint (PDF) was filed by Andrenell Johnson in the U.S. District Court for the Western District of Missouri on July 9, and alleges the makers of Elmiron exposed users to a risk of pigmentary maculopathy, retinal damage and vision problems by failing to provide adequate warnings for consumers and the medical community

Baker Norton Pharmaceuticals, Janssen Pharmaceuticals, it’s parent company Johnson & Johnson, Ivax Corporation, Alza Corporation and Bayer Healthcare Pharmaceuticals are named as defendants in the case, which joins a growing number of similar Elmiron retinal damage lawsuits being pursued throughout the U.S. court system in recent months.

Elmiron (pentosan polysulfate sodium or PPS) is the only approved drug treatment for interstitial cystitis or “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 last month.

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.

Johnson’s lawsuit indicates she began taking the drug in 2017, following an interstitial cystitis diagnosis. She took Elmiron through 2018.

“During the relevant time periods, Plaintiff and her physicians were given no warning and had no knowledge of the serious risk of retinal damage and vision loss posed by Elmiron,” the lawsuit states. “As a result of her exposure to Elmiron, Plaintiff now suffers from retinal damage, blurred vision, distorted vision, and other visual symptoms.”

Since most ophthalmologists were previously unaware that side effects of the bladder drug may impact the eyes, 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.