Patients with High Levels of Elmiron Use Have More Than a 2-Times Increased Risk of Developing Serious Eye Problems
(Posted by Tom Lamb at Drug Injury Watch)
Two new medical journal articles provide further support for the fact that past Elmiron use is associated with pigmentary maculopathy and vision loss. Remarkably, according to one medical study, patients with high levels of Elmiron use have more than a 2-times increased risk for getting a diagnosis of pigmentary maculopathy or macular degeneration.
Elmiron (pentosan polysulfate sodium, or PPS) was approved by the FDA way back in September 1996 for the treatment of painful bladder syndrome (interstitial cystitis). In recent years, however, cases of Elmiron-related eye damage have been reported.
It is important to know that a patient does not have to have been using Elmiron regularly right up until the time when their pigmentary maculopathy or macular degeneration was diagnosed in order for those conditions to be considered Elmiron-related eye damage.
The first article, "Pentosan Polysulfate and Vision: Findings from an International Survey of Exposed Individuals", was published in December 2020 by the Retina medical journal. From the Abstract for this article:
- Purpose: To investigate patient-reported visual function in individuals taking [Elmiron (pentosan polysulfate sodium, or PPS)] for interstitial cystitis.
- Results: ... Respondents in the highest [Elmiron (pentosan polysulfate sodium, or PPS)] exposure tertile were more likely to report difficulty with reading small print (adjusted OR 2.29, 95%CI 1.15-4.57) and to have a diagnosis of macular degeneration and/or pigmentary maculopathy (adjusted OR 2.41, 95%CI 1.44-4.03) than unexposed respondents.
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The second article, "Maculopathy Secondary to Pentosan Polysulfate Use: A Single-Center Experience", was published in February 2021 by the Clinical Ophthalmology medical journal. From the Abstract for this article:
- Aim: To investigate the prevalence of retinal pathology in patients with a history of exposure to [Elmiron (pentosan polysulfate sodium, or PPS)].
- Methods: Patients exposed to [Elmiron (pentosan polysulfate sodium, or PPS)] and seen in the ophthalmology clinic at Northwestern University during 1/1/2002 to 1/1/2019 were identified from electronic health records (EHR) by an electronic data warehouse (EDW) search. Visual acuity (VA), reasons for clinic visit, ocular conditions, and duration of exposure to [Elmiron (pentosan polysulfate sodium, or PPS)] were noted....
- Results: A total of 131 patients who were exposed to [Elmiron (pentosan polysulfate sodium, or PPS)] and seen at the Northwestern Ophthalmology clinic were identified in the EHR. Forty patients of 131 had imaging. Patients with imaging or fundus examination suspicious for [Elmiron (pentosan polysulfate sodium, or PPS)] maculopathy were placed into the suspect group. Of the 40 patients that had imaging, 5 (12.5%) had features suspicious for PPS maculopathy. Of the remaining 91, 5 (5.4%) had macular pigmentary changes described on fundus exam. Among the 10 patients in the suspect group, the average duration of [Elmiron (pentosan polysulfate sodium, or PPS)] use was 4.2 years... and the average cumulative dose was 380g....
We are currently investigating possible Elmiron lawsuits for patients with past Elmiron use diagnosed with eye problems such as:
Vision Loss / Blindness
Maculopathy (retinal or pigmentation)
Retinal Pigmentary Endothelium Injury (RPE)
Macular Degeneration (pigmentation or dry)
If we can be of assistance to you or someone you know with Elmiron-related eye damage, you can send an email to Tom Lamb or you can call us on our toll-free number: 800-426-9535. Or, if you prefer, simply submit an online Elmiron Case Evaluation Form -- it is free, confidential, and there is no obligation.
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