As a health publishing company devoted to interstitial cystitis, it’s our obligation to share news which may influence you, the IC affected person. Sadly, we must share some distressing information. When you’ve got or are at present taking pentosan polysulfate PPS (brand identify: Elmiron®) and are experiencing eye points, researchers at the Emory Eye Middle (Emory Faculty of Drugs, Atlanta, GA) have now documented instances of retinal maculopathy (aka retinal damage) in SOME IC sufferers who have used pentosan for long durations of time. They urge sufferers who have used or are using pentosan to be screened by ophthalmologists if they’re experiencing any unusual eye symptoms (problem reading, vision loss, problem seeing in lower lights) and to stop pentosan remedy if eye illness is present.
In Spring 2018, Dr. Neiraj Jain and collages wrote a letter to the editor of the Journal of Urology that said “We wish to alert readers to a concerning new observation of vision threatening retinal changes associated with long-term exposure to PPS. We recently reported our findings of retinal pigmentary changes in six patients undergoing long-term therapy with PPS….Each patient had received a standard dosage of PPS, ranging from 200 to 400 mgs daily, for a median duration of 15.5 years (range 12 to 20) … Examination findings of patients with this condition are suggestive of injury to the retina and the underlying retinal pigment epithelium. After extensive investigations, which included molecular testing for hereditary retinal disease, we found these cases to resemble no other retinal disease.”(1)
IC specialists Robert Moldwin and Curtis Nickel responded with concern, stating “It is quite unlikely that urologists treating patients with IC/BPS ever would have made this association…. yet the implications are either frightening if our treatment is causing this condition or instructive if this condition is a previously unknown manifestation of IC/BPS.”(2) They noted that the Emory Eye Middle had identified further instances of their clinic as well as within the clinics of colleagues.
“Pigmentary Maculopathy Associated With Chronic Exposure to Pentosan Polysulfate Sodium” was revealed in the Journal of Ophthalmology in May 2018. A case collection, it targeted on six ladies with interstitial cystitis who introduced to their clinic between May 2015 and October 2017 with pigmentary maculopathy.(three) A maculopathy is situation which impacts the middle of the retina, an space related extremely delicate and correct imaginative and prescient, reminiscent of Age-Associated Macular Degeneration.(4) Most of those patients had problem reading and problem in darkness. Two sufferers experienced a generalized dimming of their vision as the primary symptom. Two others had problem with close to imaginative and prescient. One had paracentral scotomas (imaginative and prescient loss) in part of their eye whereas the opposite had metamorphopsia (distorted imaginative and prescient the place straight strains develop into wavy).
All six sufferers underwent rigorous diagnostic imaging and DNA testing to decide if that they had any genes related to hereditary retinal loss. None had a family history of retinal disease nor the discovery of any pathogenic process. What they did have in widespread was using pentosan (aka Elmiron®) for lengthy durations of time (a median of 186 months.) Five had been handled at a dose of 400mg every day (two of whom decreased their dosage to 200mg every day after 17 years). One patient was handled with a 300mg day by day dose. No different drugs have been used by more than 2 sufferers within the research.
Examinations of their eyes showed clear modifications “Nearly all eyes (10 eyes of 5 patients) showed subtle parafoveal pigmented deposits at the level of the retinal pigment epithelium (RPE).” All eyes “showed subtle viteliform deposits that increased in number and extended beyond the major arcade of vessels in cases judged to be more severe. Four eyes of 2 patients showed RPE atrophy that was noted to increase in area and encroach on the central fovea over time. “ Findings were “fairly symmetrical” between the eyes of each affected person. Retinal imaging additionally discovered clear diseased regions and/or atrophy although the dimensions various amongst patients.
It’s necessary to observe that youngest patient in the research was just 37 years previous. Patient #4 recognized on the age of 23. She was taking 400mgs of Pentosan a day. She started displaying visible symptoms (problem with near vision and problem studying) at the age of 30, simply six years after she was recognized. She took Elmiron® for a total of 168 months. She had probably the most severe injury within the research with deep scotomas of each eyes.
The authors recommend that the retinal cells may be accumulating PPS or a toxic metabolite over time. They categorical concern that “the region of affected tissue may expand over time…” Remarkably, they point to the results of a really early Elmiron research of 2499 patients who acquired the drug for up to 4 years by which vision related antagonistic occasions have been reported together with: optic neuritis, amblyopia and retinal hemorrhage.
While they say that it’s to soon to conclude a particular relationship between PPS and maculopathy, they notice that it’s a unique presentation that doesn’t resemble some other hereditary or acquired maculopathy. Might imaginative and prescient issues be a beforehand unrecognized effect of IC? There isn’t a research which has demonstrated any long term connection between IC and eye health. The authors, specialists in the research of rare eye illnesses, stated that they can’t hypothesize a pathophysiological mechanism between the IC, the bladder and/or eye health. Additionally they state that its uncommon to speculate on a medicine toxicity 21 years after FDA approval and marvel if “perhaps chronic exposure is a requirement for development of maculopathy and we are now beginning to see patients who have met the exposure threshold to manifest a toxic maculopathy.”
They concluded with a plea for schooling and an urgent need for extra analysis. “Clinicians should be aware of this condition because it can be mistaken for other well-known macular disorders, such as pattern dystrophy and age related macular degeneration.” Of their unique letter to the editor additionally they say “We encourage drug cessation in affected patients. Furthermore, we currently recommend that any patient with suggestive visual symptoms undergo a comprehensive ophthalmic examination”
On the American Urology Association Annual Meeting (Chicago, IL) in May 2019, the Emory group submitted a new research of ten interstitial cystitis patients who had taken pentosan and experienced macular disease.(5) Ranging in age from 38 to 68, probably the most generally reported signs have been problem reading (7/10) and problem adapting to dim lighting (7/10). Sufferers had a medium cumulative exposure to pentosan of 2062 grams over time (range 325 to 2883.5) with a median period of 186 months (range 27 to 240 months). Eye examinations confirmed symmetric pigmentary modifications within the retina. Retinal imaging with FAF and OCT know-how demonstrated that the abnormalities have been main within the retinal pigment epithelium. They notice that their clinic has seen 156 patients with IC/BPS who did not have any pentosan publicity and these patients showed no pigmentary maculopathy.
They conclude that structural modifications of the retina are occurring and they’re unclear if stopping the treatment will alter the course of this retinal disease. They encourage affected sufferers to discontinue using drugs and to bear comprehensive ophthalmic examinations with OCT and FAF imaging.
- Re: FDA BRUDAC 2018 Criteria for Interstitial Cystitis/Bladder Ache Syndrome Medical Trials: Future Path for Research: J. C. Nickel and R. Moldwin J Urol 2018; 200: 39–42. William A. Pearce, Adam M. Hanif, Nieraj Jain The Journal of Urology. Revealed online: August 3, 2018 (Just two pages)
- Reply by Authors. The Journal of Urology. Revealed online: August 3, 2018 (Just two pages)
- Pigmentary Maculopathy Associated with Continual Publicity to Pentosan Polysulfate Sodium. Pearce WA, Chen R, Jain N. Ophthalmology. 2018 May 22.
- Maculopathy – Wikipedia – Accessed September 1, 2018
- Foote, et al. Continual Exposure to Pentosan Polysulfate Sodium is Related to Retinal Pigmentary Modifications and Vision Loss. AUA 2019 Summary MP47-03.
What does this imply for you
- Don’t Panic! Keep in mind that info is power! Ask your physician for copies of the articles above or go to an area medical library to find them. I’ve summarized them as greatest as I can but that’s no substitute for truly reading the articles. (They are copyright protected thus I’m not allowed to copy them.)
- Seek An Eye Examination – When you have taken Elmiron® and have also developed some eye points, out of an abundance of warning I consider that you need to search a full eye examination.
- Educate your Urologist &#zero38; Consult With Them – I encourage you to print this text out and/or reference the articles above as you speak together with your urologist. Ask them to evaluate the 2 very temporary articles within the Journal of Urology as well as the bigger article in Ophthalmology. We must unfold the word!
- Options To Elmiron – The Emory Eye Middle researchers encourage the cessation of pentosan if eye illness is famous. Other bladder coating therapies can be found, akin to Heparin/Lidocaine instillations in addition to OTC dietary supplements CystoProtek, Cysto Renew and/or Desert Harvest Aloe. Please talk about the professionals and cons together with your urologist.
An Urgent Plea – Assist Us Develop More Knowledge
I’ve created a survey to help assess if the other patients may additionally be battling eye issues and/or the position that pentosan might or will not be enjoying in these patients.
When you’ve got interstitial cystitis, PLEASE TAKE THIS SURVEY NOW – even when you have never used Elmiron or don’t have eye points. This is necessary foundational knowledge that would help justify a extra intensive research.