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An Alabama woman has filed a product liability lawsuit against the makers of Elmiron, alleging the side effects of the interstitial cystitis drug left her with a form of retinal damage and vision loss known as PPS maculopathy.
Linda Holmberg and her husband, Roy, filed a complaint (PDF) late last month in the U.S. District Court for the District of New Jersey, against the drug makers Alza Corporation, Johnson & Johnson and it’s Janssen and Ortho-McNeil subsidiaries, Bayer Healthcare and Teva Pharmaceuticals as defendants.
Holmberg began taking Elmiron (pentosan polysulfate sodium or PPS) in 2000, following a diagnosis of the painful bladder condition interstitial cystitis. Given the chronic nature of the condition, she stayed on the drug for 18 years, Although there were no warnings about the risk of vision loss from Elmiron, Holmberg indicates she developed a rare, but serious, form of retinal damage increasingly referred to as pentosan polysulfate (PPS) maculopathy, which results in permanent blurred vision and vision loss.
Although concerns have existed among some ophthalmologists for years about a potential link between Elmiron and vision problems, warnings were not added to the drug label until June 2020. However, the lawsuit suggests the manufacturers knew about Elmiron vision problems for years, but withheld information from the medical community and users.
“Almost immediately after the FDA approved Elmiron, patients and doctors began reporting serious complications relating to eye and vision problems in patients taking Elmiron,” Holmberg’s lawsuit states. “From January 1997 through March 2020, 164 cases of eye disorders were reported to the FDA as adverse effects of Elmiron, ranging from blurred vision to maculopathy and blindness. Other reported symptoms include visual impairment, halo vision, and reduced visual acuity.”
Earlier the year, the drug makers were forced to update the Elmiron warning label in the U.S., after a series of independent studies and case reports published in recent years highlighted cases involving visual injury and pigmentary changes in the retina among long-term users of Elmiron.
The rare retinal disease from PPS has been linked reports in which users to experienced difficulty adjusting in dark light, problems reading, centralized dark spots and other complications. As a result, the drug makers now face an increasing number of similar Elmiron lawsuits being filed in courts nationwide.
Since most ophthalmologists were previously unaware of the risks associated with the bladder drug, the size of the litigation is expected to continue to grow as long-term Elmiron users learn they may have been previously misdiagnosed with other retinal diseases, such as macular degeneration, pattern dystrophy and other problems, which were actually caused by the toxic effects of the drug on the eyes.