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A Wisconsin woman has filed a product liability lawsuit warning that she is likely just one of “countless” patients nationwide who have suffered severe vision loss and even blindness due to the side effects of Elmiron, an interstitial cystitis drug that may be toxic to the retina.
Teresa Townsend filed the complaint (PDF) in the U.S. District Court for the Eastern District of Wisconsin on August 14, pursuing claims against Johnson & Johnson, its Janssen Pharmaceuticals and Ortho-McNeil Pharmaceutical subsidiaries, and Teva Pharmaceuticals for misleading conduct that caused her to suffer serious vision problems.
According to the complaint, Townsend was diagnosed with interstitial cystitis in 1998 and prescribed Elmiron, which is the only approved oral medication for the condition, which is also commonly referred to as “painful bladder syndrome”. She took the medication for more than 20 years; from about 1998 to 2019, during which time the manufacturers provided no warnings about the link between Elmiron and vision loss.
Last year, Townsend indicates that she began experiencing vision problems, which included a loss of night vision, double vision, blurred vision, and dark spots. However, due to a lack of warnings, Townsend indicates that she was unaware that her use of Elmiron may cause retina damage and vision loss.
She was diagnosed with retinal maculopathy in 2019, and by March 2020 she was declared legally blind, which she indicates was a direct and proximate result of drug makers’ concealment and suppression of information about the safety of Elmiron, or lack thereof.
Elmiron (pentosan polysulfate sodium or PPS) has been marketed as safe and effective treatment for interstitial cystitis 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 June 2020.
The label update came 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 drug has been linked to reports in which users to experienced difficulty adjusting in dark light, problems reading, centralized dark spots and other complications, yet information about the risk of pigmentary maculpathy was withheld from the drug warning label for years.
“Defendants failed to disclose the known link between using Elmiron and the risk of harm to vision, including, but not limited to, pigmentary maculopathy,” Townsend’s lawsuit states. “Defendants’ misleading conduct placed Plaintiff at risk of harm, caused harm to Plaintiff, and did the same for countless other patients who were prescribed Elmiron.”
Since most ophthalmologists were previously unaware of the Elmiron vision damage risks associated with the bladder drug, a growing number of long-term Elmiron users are just now learning that 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.