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According to allegations raised in a product liability lawsuit filed against Johnson & Johnson and it’s Janssen Pharmaceuticals subsidiary, side effects of Elmiron caused a New York woman to develop a form of macular degeneration following use of the interstitial cystitis drug.
The complaint (PDF) was filed by Becky Worden in the U.S. District Court for the District of New Jersey on May 19, joining a growing number of similar complaints brought by former users indicating that Elmiron caused retinal damage, maculopathy, blurry vision and other eye problems.
Elmiron (pentosan polysulfate sodium or PPS) has been widely used as a treatment for interstitial cystitis or painful bladder syndrome since 1996, but concerns have emerged in recent years about potentially toxic side effects on the vision, with independent studies and case reports indicating that users have developed experienced difficulty adjusting in dark light, problems reading, dark spots and other complications linked to a type of retinal disease known as pigmentary maculopathy.
“Defendants knew or should have known that Elmiron, when taken as prescribed and intended, causes harmful retinal damage and maculopathy,” according to the lawsuit. “Numerous patient reports, scientific studies, and even alerts by governmental agencies have established that Elmiron causes retinal damage. Nevertheless, to date, Defendants have failed to warn, advise, educate or otherwise inform Elmiron users, prescribers or governmental regulators in the United States about the risk of pigmentary maculopathy or the need for medical, ophthalmological monitoring. As of the filing of this Complaint, the U.S. label for Elmiron makes no mention of risk to pateints’ eyes or vision.”
Worden indicates that she began taking Elmiron for treatment of interstitial cystitis in about 2003, and continued to use the drug until earlier this year, unaware of the potential side effects.
According to the lawsuit, the manufacturers knew about the potential eye problems for decades, but failed to provide adequate warning to patients or the medical community about the risk of Elmiron vision loss.
“A physician’s usage study of PPS conducted in the late 1980s and early 1990s noted adverse effects affecting vision, including optic neuritis and retinal hemorrhage,” the lawsuit states. “Defendants relied upon this very study when seeking FDA approval for Elmiron, and therefore had direct knowledge of the adverse effects.”
Although users and doctors in the United States have not been warned about these problems, the manufacturers did update the warning label in Canada last year, indicating that users should seek immediate medical attention if they experience symptoms of vision loss, and urologists were urged to make sure users of Elmiron received regular eye exams with an ophthalmologist.
Since most ophthalmologists were previously unaware of the effects of Elmiron on the eyes, many individuals have been misdiagnosed with other retinal diseases, such as age-related macular degeneration, pattern dystrophy and other problems.