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According to allegations raised in a recently filed product liability lawsuit, an Illinois man was left with permanent retinal damage and vision impairment caused by side effects of Elmiron, which was taken for more than 15 years to treat the painful bladder syndrome known as interstitial cystitis.
The complaint (PDF) was filed by Angelo Zenez earlier this month in the U.S. District Court for the Northern District of Illinois, indicating that the Johnson & Johnson subsidiaries, Janssen Pharmaceuticals and Ortho-McNeil Pharmaceuticals, Inc., subsidiaries of Johnson & Johnson, promoted Elmiron as safe and effective, without warning that it may be toxic to the retina.
Zenez indicates he took Elmiron from 1997 through 2003, for treatment of interstitial cystitis, indicating he was given no warning about the vision side effects and had no knowledge exposure to Elmiron may cause retinal damage. As a result, he now experiences difficulty reading and adapting to dark light, as well as blurred, distorted and cloudy vision.
Although Elmiron has been on the market for decades, no warnings were provided about the toxic effect the painful bladder drug may have on the retina until earlier this year, leaving many doctors unaware the medication may be the cause of blindness and vision problems experienced by long-term users.
It was only after a series of independent case reports and studies were published about the link between Elmiron and pigmentary maculopathy that the drug maker announced a warning label update in June 2020, which now advises users, urologists and opthalmologists that Elmiron may cause retinal pigmentary changes, resulting in vision problems like difficulty adjusting in dark light, trouble reading, centralized dark spots and complete blindness.
“Almost immediately after the FDA approved Elmiron, patients and doctors began reporting serious complications relating to eye and vision problems taking Elmiron,” the lawsuit states. “Nearly 150 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.”
Zenez’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.