Patients Consider Whether Relief from Bladder Pain is Worth Possibility of Elmiron-Associated Maculopathy and Other Eye Problems
Approved by the FDA way back in 1996, Elmiron (pentosan polysulfate sodium / "PPS") is prescribed for treatment of interstitial cystitis ("IC"), also known as “bladder pain syndrome” or “painful bladder syndrome”. However, in the past few years, there are case reports of Elmiron causing eye problems such as retinal pigmentary changes and pigmentary maculopathy resulting in vision loss. The current body of medical literature suggests that perhaps Elmiron side effects risks related to the eye and vision might be greater than the bladder disease treatment benefits.
Here are some medical journal articles stating that there are Elmiron side effects risks for the eye and vision of patients using Elmiron. Often this set of eye problems is generally referred to as Elmiron-associated maculopathy:
(1) This article “Pigmentary Maculopathy Associated with Chronic Exposure to Pentosan Polysulfate Sodium [Elmiron]", published by the medical journal Ophthalmology in 2018, reported on six women who used Elmiron for treatment of their interstitial cystitis and later were diagnosed with pigmentary maculopathy which was attributed to their Elmiron use.
(2) This article, "Phenotypic Spectrum of Pentosan Polysulfate Sodium [Elmiron]–Associated Maculopathy -- A Multicenter Study", published by JAMA Ophthalmology in 2019, included the following in its Key Points section:
Question: What are the exposure characteristics and clinical manifestations of pentosan polysulfate sodium [Elmiron]–associated maculopathy?
Findings: In this case series, 35 affected patients reporting long-term pentosan polysulfate sodium [Elmiron] exposure were identified. Fundus examination revealed macular pigment clumps amidst yellow subretinal deposits in mild disease with atrophy in more extensive disease, and fundus autofluorescence imaging demonstrated a pattern of abnormality centered on and involving the fovea, occasionally extending to the retinal periphery.
Meaning: These findings suggest pentosan polysulfate sodium [Elmiron]–associated maculopathy is a vision-threatening condition that can manifest in the setting of long-term exposure to the drug, and multimodal imaging posits a distinctive clinical phenotype.
(3) From "Association of Macular Disease with Long-Term Use of Pentosan Polysulfate Sodium [Elmiron]: Findings from a U.S. Cohort", published by the British Journal of Ophthalmology in 2019: “PPS [Elmiron] users had significantly increased odds of having atypical maculopathy . . . .”
(4) And a news report about Elmiron, "More evidence linking common bladder medication to a vision-threatening eye condition", published in 2019 had this rather alerting sub-title: "New study shows about a quarter of patients with significant exposure to the [Elmiron] show signs of retinal damage".
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Here are two medical journal articles suggesting that the bladder disease treatment benefits of Elmiron are not that great, to say the least.
(1) From “A Pilot Clinical Trial of Oral Pentosan Polysulfate [Elmiron] and Oral Hydroxyzine in Patients with Interstitial Cystitis", published by the Journal of Urology in 2003: “The low global response rate for PPS [Elmiron] and hydroxyzine suggest that neither provided benefit for the majority of patients with IC.”
(2) From “Pentosan Polysulfate [Elmiron] for Treatment of Interstitial Cystitis/Bladder Pain Syndrome: Insights from a Randomized, Double-Blind, Placebo Controlled Study", published by the Journal of Urology in 2015: “Results of this study in a broad population of patients with symptoms consistent with interstitial cystitis revealed no treatment effect vs. placebo for pentosan polysulfate sodium [Elmiron].”
In June 2020 the FDA provided some clarity to this Elmiron drug safety issue when it mandated an Elmiron label change which added cautions about retinal pigmentary changes, otherwise known as pigmentary maculopathy, to the "Warnings and Precautions" as well as the "Adverse Reactions" sections of the Elmiron drug label.
But for patients who used Elmiron before there were those warnings added by the June 2020 Elmiron label change, they are left wondering whether relief from bladder pain is worth the possibility of developing Elmiron-associated maculopathy or some other eye problem.
We are currently investigating possible Elmiron drug injury lawsuits for patients diagnosed with a vision-related Elmiron side effect.
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