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According to allegations raised in a recently filed product liability lawsuit, a South Carolina woman suffered vision loss, macular degeneration and other eye damage from Elmiron, a prescription treatment used for treatment of interstitial cystitis or “painful bladder syndrome”.
The complaint (PDF) was filed by Barbara English in the U.S. District Court for the Eastern District of Pennsylvania on May 4, indicating that Johnson & Johnson and it’s Janssen Pharmaceuticals knew about the risk of retinal damage users may face, yet failed to warn patients or the medical community, resulting in irreversible vision problems.
English indicates she began taking Elmiron in 2001, and continued to use the medication for nearly two decades due to her interstitial cystitis diagnosis, which is an incurable condition that results in severe bladder and pelvic pain. In about 2017, English began experiencing vision problems, and was diagnosed with permanent retinal injury, macular degeneration and vision loss in April 2019, which the lawsuit says was caused by the long-term use of Elmiron.
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, which is often taken by users for years. However, over the past year, a series of studies and case reports have suggested a link between side effects of Elmiron and eye damage.
Research suggests that the drug has a toxic effect on the eye, resulting in the development of a retinal disease known as pigmentary maculopathy, which may lead to irreversible vision loss, dark spots, difficulty adjusting to dark light and other problems.
“Since the original report, there have been more than a dozen papers published in the medical literature regarding the atypical maculopathy associated with Elmiron use,” the lawsuit states. “Despite these publications, Defendants have made no change to the label in the United States or taken any steps to warn the medical community and users of the drug regarding these effects.”
Although users and doctors in the United States have not been warned about the risk of Elmiron eye damage, 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.
The case filed by English joins a number of other Elmiron lawsuits now being pursued in courts nationwide, ech 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 toxic 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.