Update on Elmiron Safety Warnings
ELMIRON WARNINGS IN CANADA
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.
RECENT STUDY SUPPORTS A LINK BETWEEN ELMIRON AND RETINAL MACULOPATHY
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.


Know the Difference
Committed to Doing What's Right-
Over $3 Billion Won
We have represented numerous individuals and groups of workers, winning for them multi-million-dollar settlements and verdicts.
-
There's No Case Too Big
Our team has achieved groundbreaking victories in highly complex cases and has gone up against some of the toughest defendants in the country.
-
Trial Attorneys
Our attorneys excel in the courtroom and are not afraid to bring a case in front of a jury if a fair settlement for the client has not been reached.
-
A Thought Leader in the Industry
Our firm's knowledge and experience are in high demand, and many news outlets have asked us to share our legal expertise.
-
Access to World Class Resources
Our experienced attorneys use cutting-edge technology and highly regarded experts to help us achieve the best possible result for our clients.
-
Changing the World for Good
We not only want to achieve the best possible results for our clients, but we also strive to prevent future harm by changing public health policies.

Thousands of Clients Helped
Hear What They Have to Say
-
Professional, responsive and very good at their jobs.
“From the first visit to my home, to my last visit to the office to collect my settlement, I was very happy with the services provided by this firm. They are professional, very responsive and very good ...”
- Lisa Ross -
They have truly gone above and beyond.
“I have been beyond pleased how Levy Konigsberg is handling my matter. They answer my questions in a timely matter and when warranted, ease my worries and concerns. They have truly gone above and ...”
- Anne Fahey -
I put my Faith and Trust into Corey Stern!
“Selecting a Law firm to represent me was one of the biggest decisions I've had to make in my life. I put my Faith and Trust into Corey Stern, and he exceeded all my expectations.”
- Dennis McGowan -
With this team on my side we came out on top.
“Levy Konigsberg and team are a group of men and women that give their all, down to the receptionist. I had a case that was almost unbeatable but with this team on my side we came out on top. They keep ...”
- Angie Garrido -
Very happy with our settlement.
“My husband and I were VERY happy with our experience with this firm. They were always caring and really helped us go through this in a very hard time in our lives .We continue to be in touch with the ...”
- Lori Rosa -
Wow is all I can say.
“It has been a few years now but I needed to post this. My dad suffered so much from Mesothelioma. My brother looked into the law and our rights. Unfortunately he died also before anything was done. It ...”
- Carol N. -
Their dedication to receive the highest results for their clients was amazing.
“Working with Levy Koningsberg LLP was a very positive experience. Their professionalism and curiosity was outstanding. I was a pleasure working with this firm. Their dedication to receive the highest ...”
- Emily DeRogatis -
Such a great team!
“The whole team at Levy, Konigsberg LLP have been extremely professional and kind during our most difficult time. They keep you informed during the process, check in often asking if there are any ...”
- Kevin Kober -
We definitely got the right law firm!
“Levy Konigsberg represented my daughter Linda, who was diagnosed with mesothelioma at 16 years old. She endured many surgeries and chemotherapy including HIPEC. She traveled the country seeking ...”
- Mark Wells -
Levy Konigsberg continued to help my family fight for the justice my father deserves.
“Levy Konigsberg was there for my father as soon as he was diagnosed with mesothelioma they helped him get medical treatment in another state that specializes in his condition and even provided housing ...”
- Stephanie Vitale


Our Blog
-
Illinois Attorney General Finds Catholic Church Vastly Underreported Clergy AbuseView Article
- Sexual Abuse
-
Levy Konigsberg Files 10 Taconic Sex Abuse Claims On Behalf of SurvivorsView Article
- Sexual Abuse
-
Jerome Block Featured on CNN Investigation into J&J Powder Cancer ClaimsView Article
- Firm News,
- Social Media,
- Asbestos Litigation