New Research Finds “Strong Dose-Dependent Association” Between Elmiron and Retinal Maculopathy

The findings of a new study involving the interstitial cystitis drug Elmiron point to a strong dose-dependent relationship between long-term Elmiron use and prominent macular dysfunction identified as retinal maculopathy. The study was conducted by researchers from Emory University School of Medicine in Atlanta, where the first known cases of Elmiron-related maculopathy were identified by doctors at the Emory Eye Center back in 2018. If you or someone you know took Elmiron for interstitial cystitis and subsequently experienced vision loss or eye damage characteristic of retinal maculopathy, do not hesitate to speak to an Elmiron injury attorney about your legal options. Contact Consumer Safety Watch today to find out how we can help you with your claim.

Link Between Elmiron and Vision Loss

Over the past several years, there has been mounting evidence of a link between chronic exposure to Elmiron and a novel retinal maculopathy that can lead to vision loss. “Recent studies have described a progressive, vision-threatening macular condition associated with long-term PPS use,” the Emory University researchers note in this latest Elmiron study, published last month in the medical journal Survey of Ophthalmology. To assess the strength of this association, the researchers reviewed all of the currently available data pertaining to Elmiron use and reports of retinal maculopathy.

“Current literature supports a strong dose-dependent association between PPS exposure and a progressive maculopathy impacting the retinal pigment epithelium (RPE) and RPE-photoreceptor interface that may worsen even after drug cessation,” the Emory University researchers wrote. “Initial symptoms may include prolonged dark adaptation and difficulty reading with relative visual acuity preservation.” They also noted that Elmiron users may experience RPE atrophy, cystoid macular edema, and macular neovascularization, “potentially resulting in loss of central acuity,” or the loss of detail vision.

What is Elmiron Used to Treat?

Elmiron (pentosan polysulfate sodium, or PPS) is the only oral treatment for interstitial cystitis (IC), an incurable bladder condition characterized by incontinence, bladder or pelvic pain, and other uncomfortable, persistent symptoms. Approximately one million people in the U.S. suffer from interstitial cystitis, the majority of them women, and since the medication was FDA-approved for use in 1996, hundreds of thousands of patients with the bladder condition have been prescribed Elmiron. Although Elmiron has been on the market in the U.S. for more than two decades, seemingly without any indication of potential toxicity problems, a growing body of evidence now suggests that Elmiron may have a toxic effect on the retina, possibly leading to irreversible vision loss.

Elmiron-Related Maculopathy Identified at Emory Eye Center

Since doctors at the Emory Eye Center first identified diagnosis of IC and exposure to Elmiron as the common denominator in a case series involving six patients who reported difficulty reading, prolonged dark adaptation, and vision loss, subsequent case series and cohort studies have reported similar findings involving a pattern of Elmiron exposure and vision problems. This pattern is so prominent, in fact, that many doctors and scientists refer to the novel eye disease as pentosan polysulfate maculopathy. Among the symptoms observed in individuals affected by Elmiron-related maculopathy are blurred vision, metamorphopsia, and prolonged dark adaptation, and many affected individuals have been misdiagnosed with other more common eye conditions like age-related macular degeneration or macular or pattern dystrophy.

Permanent Vision Loss from Elmiron Use a Major Safety Issue

These findings present a major safety issue for patients with chronic Elmiron exposure who may have been misdiagnosed with another eye disease, and as a result, suffered preventable, irreversible vision loss. Unfortunately, as the Emory University researchers note, the progressive maculopathy associated with Elmiron use may worsen even after treatment is discontinued, which means anyone who took Elmiron in the past may now be at risk for retinal maculopathy, even if they are no longer taking the medication. In light of this apparent dose-dependent relationship between Elmiron use and retinal maculopathy, the researchers recommend that “ophthalmologists should screen PPS users with multimodal retinal imaging, and prescribers should minimize dose and duration of PPS use.”