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According to allegations raised in a product liability lawsuit, Johnson & Johnson and it’s Janssen Pharmaceuticals subsidiary failed to adequately warn about the macular toxicity risk with Elmiron, an interstitial cystitis drug that left a Kansas woman with permanent vision loss and eye problems.
The complaint (PDF) was filed by Rebecca Gassman in the U.S. District Court for the Eastern District of Pennsylvania on May 11, indicating that the drug makers withheld critical information from consumers, urologists and ophthalmologists about the potential link between Elmiron and vision loss, causing long-term users to experience permanent macular degeneration.
Gassman indicates that she began taking Elmiron in about 2010, for the treatment of interstitial cystitis and bladder pain. However, after using the medication for about nine years, she began suffering vision problems and was diagnosed with macular degeneration, permanent retinal injury and vision loss in March 2020.
According to the lawsuit, the injuries were caused by the toxic side effects of Elmiron on the vision and retina, which can result in progressive deterioration of the eyes that is irreversible.
Elmiron (pentosan polysulfate sodium or PPS) has been sold by Johnson & Johnson’s Janssen Pharmaceuticals subsidiary in the United States since 1996, and has been promoted as a safe and effective treatment for interstitial cystitis. However, a growing number of studies and case reports now suggested users may develop a type of retinal disease known as pigmentary maculopathy, which can leave them with severe difficulty adjusting in dark light, difficulty reading, dark spots and other problems.
Gassman’s lawsuit indicates the manufacturers knew there was a risk of Elmiron macular toxicity, but failed to warn patients and the medical community for years, even after reports of problems began to roll in.
“Defendants 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,” the 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, Defendants continued to market Elmiron as a safe and effective prescription drug for interstitial cystitis.”
Although users and doctors in the United States have not been warned about these problems, the manufacturers did update the warning label in Canada last year, indicating that users should seek immediate medical attention if they experience symptoms of vision loss, and urologists were urged to make sure users of Elmiron received regular eye exams with an ophthalmologist.
Gassman’s complaint joins a growing number of other Elmiron lawsuits now being pursued in courts nationwide, each raising similar allegations that users could have avoided irreversible eye damage if warnings had been provided by the drug makers.
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.