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According to allegations raised in a recently filed lawsuit, side effects of Elmiron left a New York woman with blurred and cloudy vision, indicating the drug manufacturers withheld information from users and the medical community about the risk of permanent retinal damage associated with the interstitial cystitis treatment.
The complaint (PDF) was filed by Marianne Benvenuti in the U.S. District Court for the Western District of New York on January 7, alleging Johnson & Johnson and its Janssen Pharmaceuticals subsidiary failed to adequately investigate the threat Elmiron poses to vision, or warn about the risk users may be left with an irreversible retinal injury and vision impairment.
Although Elmiron has been on the market for decades, no warnings were provided about the toxic effects the painful bladder drug may have on the retina until earlier this year, leaving many doctors unaware the medication was causing users to experience a variety of complications, including difficulty adjusting to dark light, trouble reading, centralized dark spots and complete blindness.
Since urologists prescribing the medication, as well as ophthalmologists consulted for the vision problems, were unaware the symptoms may be the result of Elmiron side effects, many users remained on the medication, even though it was causing worsening damage to the retina.
It was only after a series of independent case reports and studies were published about the link between Elmiron and vision problems that the drug maker announced a warning label update in June 2020, which now advises that users may face a risk of retinal pigmentary changes and urges doctors to closely monitor vision while taking Elmiron.
Benvenuti indicates she was prescribed Elmiron to treat her interstitial cystitis, which involves bladder and pelvis pain that is not curable. Therefore, she remained on the drug from 2011 through 2019, unaware exposure to Elmiron was the cause of her maculopathy, blurry and cloudy vision.
“The labeling for Elmiron lists serious side effects that have been reported with Elmiron, but do not list vision threatening retinal changes. Defendants also did not make any mention of vision threatening retinal changes or the need for ophthalmological monitoring in any of the patient materials – including the Patient Education Fly and Elmiron Patient Brochure – the sources of information most likely viewed by physician and patients,” Benvenuti’s lawsuit states. “The labeling for Elmiron does not provide adequate warnings, does not caution patients should be closely monitored, does not adequately inform patients and physicians that vision threatening retinal changes have been associated with Elmiron use, and does not contain any proper dosing considerations.”
Benvenuti’s claim joins a growing number of Elmiron lawsuits now being pursued throughout the U.S. court system, which were recently centralized for pretrial proceedings before one judge in the U.S. District Court for the District of New Jersey, where there are currently about 100 cases pending. However, as Elmiron lawyers continue to review and file claims in the coming months and years, it is expected several hundred, if not thousands, of similar complaints may be brought on behalf of former users nationwide.