Elmiron Macular Degeneration Lawsuit Filed Over Toxic Effect on Retina

A growing number of Elmiron lawsuits continue to be filed by long-term users of the interstitial cystitis drug, alleging that the drug maker failed to warn about the effects the drug may have on the retina and vision.

In a complaint (PDF) filed late last week in the U.S. District Court for the Eastern District of Pennsylvania, plaintiff Kimberly S. Pelczar indicates that she developed macular degeneration and permanent retinal damage after using the drug for about ten years.

According to allegations raised in the lawsuit, Johnson & Johnson and it’s Janssen Pharmaceuticals subsidiary knew about the toxic effect Elmiron may have on the vision, yet withheld warnings from consumers and the medical community for years.

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 earlier this month.

In recent years, a series of studies and case reports published by independent researchers have highlighted cases involving visual injury and pigment changes in the retina among long-term users of Elmiron. This has resulted in complaints that users experienced difficulty adjusting in dark light, problems reading, centralized dark spots and other complications associated with a unique type of retinal disease known as pigmentary maculopathy.

“Defendant designed, marketed, and distributed Elmiron in the United States, all the while knowing significant risks that were never disclosed to the medical and healthcare community, including Plaintiff’s prescribing doctor, Food and Drug Administration, to Plaintiff, and/or the public in general,” the lawsuit states. “Further, Defendant failed to provide adequate warnings to patients and the medical community, including Plaintiff’s prescribing physician, of the risks associated with using the drug.”

Pelczar indicates that she was prescribed Elmiron in 2005, for treatment of bladder pain, and continued to use the medication for more than 10 years. In 2015, she began to experience vision problems, which went undiagnosed for years. It was not until after the first case reports were published in medical literature about the problems with Elmiron that she was diagnosed with permanent retinal injury and vision loss due to Elmiron toxicity.

Since most ophthalmologists were previously unaware of the effects of Elmiron on the eyes, many individuals have been misdiagnosed with other retinal diseases, such as age-related macular degeneration, pattern dystrophy and other problems.

Following the announcement earlier this month that new information would be added to the Elmiron warning label about reports of maculopathy and vision loss, the number of cases filed in courts nationwide is expected to continue to increase in the coming months and years, as individuals suffering from problems for years contact Elmiron lawyers.