Elmiron Vision Side Effects Lead to Concerns About Maculopathy Risk Following Long-Term Use of Bladder Drug

As a growing body of research suggests that side effects of Elmiron may cause a vision-threatening type of maculopathy, long-term users of the interstitial cystitis drug are seeking additional information about how to best monitor or test for the retinal deterioration.

Elmiron (pentosan polysulfate sodium or PPS) has been sold by Johnson & Johnson’s Janssen Pharmaceuticals subsidiary in the United States since 1996, and has been promoted as a safe and effective treatment for interestitial cystitis or painful bladder syndrome, resulting in most users taking the drug for years.

Over the past year, a series of studies and case reports have suggested a link between Elmiron and vision side effects known as pigmentary maculopathy, which may lead to irreversible vision loss, dark spots, difficulty adjusting to dark light and other problems.

Late last year, a study published in the medical journal JAMA Ophthalmology highlighted the Elmiron maculopathy risk, suggesting that more work needs to be done to explore the best vision screening guidelines for long-term users of the medication. However, more than six months later, the drug maker continues to provide no warnings or information for users of the medication.

In the study, researchers looked at data on 35 patients who underwent fundis examinations, which included dilation and autoflorescence imaging (retinal mapping). After reviewing the findings, researchers described characteristics of the unique PPS-associated maculopathy, indicating that examinations revealed clumps of macular pigment, yellow subretinal deposits, and increased atrophy when the disease was further along.

Hyperpigmented macular spots occurred in 53% of the eyes examined, and retinal pigment epithelial atrophy occurred in 23%.

“These findings suggest that PPS-associated maculopathy is a vision-threatening condition that can manifest in the setting of long-term exposure to the drug,” the researchers warned. “Ongoing work might explore causality and direct screening guidelines.”

Although Elmiron warnings about difficulty reading, dark adaption and other vision symptoms were added to the warning label in Canada in October 2019, indicating that users should have regular ophthalmologist exams for early detection of the problems, similar information still has not been provided to doctors in the United States.

With Elmiron vision loss lawsuits now being pursued in courts nationwide, a number of former users in the United States are just now learning that their long-term use of the bladder drug may be the cause of on-going vision side effects. Given a lack of prior warnings and information provided by the drug maker about the unique pigmentary maculopathy risk with Elmiron, many individuals were misdiagnosed with other retinal diseases, such as age-related macular degeneration, pattern dystrophy and other problems.

According to allegations raised in product liability claims being pursued by former users, long-term retinal damage may have been avoided if information had been provided about the importance of monitoring for symptoms of vision changes, as simple ophthalmologist testing could have detected the issues.