Elmiron Related Eye Disease Facts and Timeline
May 2018 – Elmiron vision loss noted at the Emory Eye Center. A case series presented six cases of women with interstitial cystitis between 2015 and 2017 with pigmentary maculopathy. Most patients had difficulty reading and difficulty with night vision or in darkness. Two of the patients had experienced a dimming of their vision. One had paracentral scotomas (vision loss) in part of their eye while another had distorted vision where straight lines become wavy. Two others had difficulty with their near sight. None had family history of retinal disease or any genes associated with hereditary retinal loss. What all patients did have in common was the long term usage of Elmiron for many years.
Letter to the editor was published in the Journal of Urology, responding to a report published in July 2018. Researchers with the Emory University School of Medicine wrote to alert readers on new observations involving retinal changes and vision loss associated with long term Elmiron use and exposure.
Expanded Data was presented at the American Urology Association Annual Meeting in May 2019. The Emory team submitted anew study of ten interstitial cystitis patients who had taken pentosan polysulfate PPS (Elmiron) and experienced macular disease. Eye examinations showed symmetric pigmentary changes in the retina and abnormalities were primary in the retinal pigment epithelium. Researchers described a uniqueness in the type of pigmentary maculopathy and those problems were not present in the 156 other patients treated for the same bladder condition who were not using Elmiron or pentosan polysulfate.
Canadian researchers reviewed medical records of 35 long-term Elmiron users who were thought to have maculopathy conditions. They described the condition in a published study as “pentosan polysulfate sodium (PPS)-associated maculopathy” or Elmiron maculopathy. Read more about Canadian Elmiron Maculopathy results
October 2019 – First Clinical Population Based Study
California opthalmologists reviewed records from a database of millions of patients and found 140 patients who had taken an average of 4000 elmiron pills over a 15 year period. A majority agreed to come in for a eye exam. Of the eyes examined, approximately a quarter were determined to contain elmiron drug toxicity. These patients showed eye damage and that the damage increased with the quantity of Elmiron used. The elmiron retina toxicity mimicked age-related macular degeneration (AMD) and can result in permanent vision loss or blindness.
November 2019 – National Multicenter Study Released
Findings released by the Emory Eye Center in Atlanta Georgia revealed at 7 years, pentosan users had significantly increased odds of having the atypical maculopathy. This result was shown through using data sets from a US medical claims database.
January 2020 – Elmiron and Retinal Toxicity
Patients exposed to greater than 1500 g of PPS or Elmiron are at significant risk of retinal toxicity. UCLA researchers performed a cross-sectional study of patients previously or currently treated with Elmiron. The prevalence of Elmiron or PPS associated maculopathy was approximately 20% of patients. More significant exposure was associated with more severe atrophy.
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