The Firm You Go to When the 
Stakes Are High

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.

A TEAM COMMITTED TO DOING WHAT IS RIGHT

Find out whether you have a case by speaking to one of our experienced mesothelioma 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
  • They truly made a difference in our lives!

    “Levy Konigsberg went above and beyond in representing my father in his mesothelioma case against multiple parties. From providing a risk free introduction (even flying out at their expense to speak to my father in person) to fighting diligently for us.”

    - Jonathan McNulty
  • Outstanding law firm!

    “Jerry and Bob are not only experts in their field, but genuinely care about their clients. They explain the entire process in a step like manner and are keenly aware that the health and medical treatment of the defendant should not be compromised.”

    - R.M.
  • No need to look any further.

    “The attorneys were attentive to my fathers needs during all proceedings while at the same time aggressive with the defendants making sure my father got everything he deserved.”

    - Todd Allen
  • They were the clear choice!

    “Jerry Block was compassionate and assembled a team of attorneys that knew exactly what to do. Although no amount of money can replace my father, we are grateful to them for giving him the gift of knowing that his family would be taken care of.”

    - Bruce Totterdale
  • Forever grateful!

    “They were not only knowledgeable but also compassionate. It was comforting to know they were diligently working on his case so we could focus on his medical care. Levy Konigsberg became part of our journey and we are forever grateful.”

    - Diane Hoefer
  • The best and brightest!

    “They never failed to keep us informed of all important developments in the case, and they always gave a realistic idea of when the matter would be resolved. I always felt that my dad was excellently represented, and that his case was in the best hands.”

    - Paulette
  • Simply incredible!

    “Corey Stern was simply incredible! Not only did he keep me well informed as to what was transpiring with my case, but was direct and honest all the way through. His hard work and compassion resulted in an amazing settlement.”

    - IBS LMM
  • Knowledgeable guidance and representation.

    “Your firm explained all of the steps involved in filing my case, took the time to update me as it progressed, prepared me for my meeting with NYS officials… Without your knowledgeable guidance and representation, I may not have been successful.”

    - Steven Simon
  • They are good people who want to help you.

    “I am now in a more comfortable financial situation. I can now go out and buy myself the things I need, without worrying how I am going to do that. Because I am well aware that I am not capable of getting or keeping a job.”

    - Edwin Jimenez
  • They won us a lot of money.

    “Levy Konigsberg, in my opinion, is a great law firm. They took very well care of us and I believe that they cared very much about our case. They were great attorneys.”

    - Karen
LEVY KONIGSBERG IN THE NATIONAL MEDIA

CHOOSE LEVY KONIGSBERG

Start with a FREE Consultation
  • Please enter your first name.
  • Please enter your last name.
  • Please enter your phone number.
    This isn't a valid phone number.
  • Please enter your email address.
    This isn't a valid email address.
  • Please make a selection.
  • Please enter a message.