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Update on Elmiron Safety Warnings


Since 2018, reports by medical authorities, including the American Academy of Ophthalmology, have established a link between the prescription drug Elmiron and retinal maculopathy. Maculopathy includes several pathological disorders of the central part of the retina that may result in long-term vision impairment if left untreated. Canadian health authorities have now issued an alert about the occurrence of pigmentary maculopathy in patients who use Elmiron on a long-term basis.

In December 2020, Health Canada, along with Janssen Inc., revised the Canadian Product Monograph for Elmiron to provide new information about the risks of the medication. Health Canada’s safety alert advises healthcare professionals that Elmiron is contraindicated in individuals who have a history of macular pathology. The bulletin recommends that healthcare professionals evaluate the risks of Elmiron before prescribing it to treat interstitial cystitis or “bladder pain syndrome.” This includes collecting ophthalmologic history prior to treatment, conducting routine eye exams for patients using the medication, and advising patients to report vision changes to their physicians.

The alert informs healthcare professionals that pigmentary maculopathy can result in permanent and progressive eye damage. The majority of reported eye changes were seen in patients taking Elmiron for three years or more. However, some cases of retinal damage were observed in patients using Elmiron for a shorter period of time.


A recent report in Practical Retina published in December 2020 addresses the interaction between pentosane polysulfate sodium (PPS) (brand name Elmiron) and pigmentary maculopathy. The authors discuss the challenges of exposing retinal toxicity in new medications. This is evident in the prolonged time period between approval of Elmiron by the U.S. Food and Drug Administration (FDA) in 1996 and the FDA’s label warning update concerning retinal maculopathy in June 2020. Before discovering this association, most patients were misdiagnosed with atypical age-related macular degeneration or pattern dystrophy.

The authors noted the emergence of a “novel maculopathy” over the last two years that is associated with PPS. PPS, used to treat interstitial cystitis, is the only oral medication of the two FDA-approved therapies for interstitial cystitis. Interstitial cystitis affects more than 1 million people in the United States. In the case studies on PPS exposure, patients were generally white women with a median age of 60 years. These patients reported blurred vision, prolonged dark adaptation, and metamorphopsia (a visual defect causing linear objects to appear curved). The characteristics of PPS-induced maculopathy were distinct from other types of macular dystrophies, leading researchers to conclude that toxic PPS metabolites are responsible for the development of pigmentary maculopathy.

From other findings in the literature, it is estimated that 20%-25% of patients taking PPS develop maculopathy. Those who had symptoms of maculopathy reported that they used PPS therapy for anywhere from 3 to 22 years. Maculopathy symptoms developed with cumulative drug exposures greater than 500 grams and severe maculopathy was observed in doses exceeding 1,500 grams. Other therapies for interstitial cystitis did not indicate a risk of developing maculopathy. These results raise significant concerns since a large number of patients with PPS exposure may have been misdiagnosed. Studies have also shown progression of visual impairment associated with Elmiron even after patients have discontinued the medication.

Contact our Elmiron Lawyers to review whether you or a family member may be entitled to financial compensation. Levy Konigsberg LLP is currently accepting Elmiron cases in all 50 states. If you or a loved one has suffered from visual impairments after taking Elmiron, you may be entitled to a cash award and compensation for medical expenses. For a free and confidential consultation with Elmiron Lawyers at our law firm, please call (800) 315-3806 or submit an email inquiry.


Find out whether you have a case by speaking to one of our experienced lawyers via our 24/7 toll-free hotline or by submitting an email inquiry. Our attorneys will be quick to respond to you and happy to answer all of your questions.

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