Drug Safety alert: Elmiron-Associated Maculopathy and Other Eye Problems

Elmiron (pentosan polysulfate sodium / “PPS”) was approved by the FDA in 1996, is prescribed for treatment of interstitial cystitis, 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,
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”.