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In a recently filed product liability lawsuit, a Kansas woman indicates that she developed macular degeneration and vision loss from side effects of Elmiron, a drug she took for about 15 years as treatment for interstitial cystitis or “painful bladder syndrome.
The complaint (PDF) was filed last week by Megan K. Mott, in the U.S. District Court for the Eastern District of Pennsylvania, indicating that the Johnson & Johnson subsidiary Janssen Pharmaceuticals knew about significant vision risks associated with Elmiron, yet continued to market the drug for years without disclosing the information to consumers and the medical community.
Mott indicates that she began taking Elmiron in 2005, which contained no information on the warning label about toxic side effects the drug may have on the retina. Following long-term use, Mott began to suffer various visual symptoms, and was eventually diagnosed with Elmiron-related macular degeneration in March 2020, which has left her with permanent vision loss.
Elmiron (pentosan polysulfate sodium or PPS) is the only approved drug treatment for interstitial cystitis or painful bladder syndrome, and has been marketed by Janssen Pharmaceuticals 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.
Mott’s lawsuit indicates Janssen knew about Elmiron problems, but ignored the warning signs and withheld information to protect profits.
“Defendant ignored reports from patients and health care providers throughout the United States of Elmiron’s failure to perform as intended, and injuries associated with long term use which led to the severe and debilitating injuries suffered by Plaintiff, and numerous other patients,” her lawsuit states. “Rather than doing adequate testing to determine the cause of these injuries or rule out Elmiron’s design as the cause of the injuries, Defendant continued to market Elmiron as a safe and effective prescription drug for interstitial cystitis.”
The case joins a growing number of similar Elmiron lawsuits being pursued against Janssen throughout the federal court system, each involving nearly identical allegations that the drug maker failed to warn about side effects that may cause macular degeneration, vision loss and other retinal damage.
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.