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A recently filed lawsuit alleges that side effects of Elmiron caused a long-term user of the bladder drug to suffer permanent vision damage, indicating that the eye problems could have been avoided or less severe if the drug makers had properly disclosed the risk.
The complaint (PDF) was filed by Lynn Brewer in the U.S. District Court for the District of New Jersey on June 24, indicating Janssen Pharmaceuticals, its Johnson & Johnson parent company, and Teva Pharmaceuticals knew or should have known about the link between Elmiron and vision damage, yet withheld information from users and the medical community.
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 comes after a series of independent studies and case reports published in recent years have highlighted cases involving visual injury and pigmentary changes in the retina among long-term users of Elmiron. The drug has been linked to the development of a rare retinal disease known as pigmentary maculopthy, which can cause users to experience difficulty adjusting in dark light, problems reading, centralized dark spots and other complications.
Brewer indicates she began taking Elmiron in 2005, for the treatment of interstitial cystitis-related pain. However, that same year, shortly after beginning treatment, she was diagnosed with vision loss due to maculopathy and other vision injuries. Since information about the toxic side effects of Elmiron on the retina were not disclosed by the drug makers, she continued to use the medication until 2019, causing further damage.
In addition to Elmiron-associated maculopathy, Brewer indicates she suffered severe vision degradation, loss of nightvision, changes in eye color pigment and pigmentary maculopathy, the lawsuit states.
“Mrs. Brewer would not have used Elmiron had any or all of Defendants’ properly disclosed the risks associated with its use,” according to her lawsuit. “Mrs. Brewer’s injuries could have been avoided or would have been less severe had any or all of Defendants properly disclosed the risks associated with its use.”
The complaint comes as a growing number of Elmiron vision damage lawsuits are now being filed throughout the federal court system. Since most ophthalmologists were previously unaware that side effects of Elmiron may impact the eyes, many individuals indicate they were previously misdiagnosed with other retinal diseases, such as macular degeneration, pattern dystrophy and other problems.