Giving Back

Interstitial Cystitis, Elmiron and Vision Damage

Christiana Lilly
July 28, 2023

While most people walking into a restaurant are on the lookout for the best table to enjoy a meal with their friends and loved ones, there are others who are scoping out where the nearest bathroom is.

For those who suffer from interstitial cystitis (IC), an umbrella term for painful bladder syndrome, knowing where the restroom is located is vital. Many have chosen to take the drug Elmiron, the only FDA-approved medication to treat IC, with much success.

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However, it has come at a cost, as new research has revealed that vision damage can be a serious side effect of taking the drug that was never mentioned, leading to Elmiron lawsuits against Jansseen Pharmaceuticals (the manufacturer of the drug).

It is vital that urologists and urogynecologists be informed of the now serious risk of eye disease in patients who are using Elmiron®. At a minimum, patients should be encouraged to have annual eye examinations to determine if any retinal changes are occurring. And, as recommended in almost every study, the medication should be discontinued if eye damage is occurring.

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What is Interstitial Cystitis?

A chronic bladder condition, it affects up to 12 million men and women in the United States - more often women -  and most people who have the condition suffer from pelvic pain and urinary urgency. It can be disruptive, as those who suffer from IC can turn down social invitations or stress over a backup plan for every scenario they are in to avoid a potentially embarrassing situation. The condition can even go so far as to impact their ability to work, getting a good night’s rest, or enjoying a healthy sex life.

Unfortunately, doctors aren’t sure what causes IC, but some people are able to manage their symptoms with exercise and changing their diet. According to the Interstitial Cystitis Association, patients have found that light exercises such as yoga, Pilates, walking and Tai Chi can be helpful in managing their symptoms. When it comes to diet, there isn’t a one-size-fits-all list of foods to avoid, so patients should talk to their doctor about any allergies they have that might be exacerbating their IC symptoms.

Because cranberry is a natural remedy to help avoid urinary tract infections, it can seem like a logical step to use it to treat IC. However, for those with IC, the acid can actually be an irritant and even cause further damage to the bladder. Other remedies for dealing with IC include pelvic floor physical therapy, pain relievers, and stress management exercises, although some take more drastic measures such as bladder augmentation or removal. As always, talk to your doctor before starting a new regimen.

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Damaging Side Effects of Elmiron

When natural remedies, exercise, and a change of diet don’t alleviate the pain and urgency caused by IC, many choose to go the route of taking medication for treatment. Enter Elmiron (pentosan polysulfate sodium), a medication introduced in 1996 and the only FDA-approved medication to treat IC. Although it is not clear what exactly about it helps with bladder pain, it is believed that the mild blood thinner protects the bladder.

But, the medication has come at a cost for some patients, with many filing lawsuits against Elmiron for allegedly damaging their vision, or more specifically, pigmentary maculopathy. Symptoms include difficulty reading, difficulty adapting to dim or dark light, dark spots, eye pain, and even blindness. Because those who are taking Elmiron tend to be older, the vision damage tends to be misdiagnosed in many cases for age-related maculopathy or just natural vision deterioration.

According to a 2018 study published in Ophthalmology, the journal of the American Academy of Ophthalmology, the patients studied all complained of difficulty reading and even more serious vision problems in the time they took Elmiron. This breakthrough has led to more physicians taking a serious look at the link between vision loss and Elmiron along with further research studies being created to examine this link.

In 2019, a much larger study found that one-quarter of those who were taking Elmiron experienced vision problems. Those behind the study believe the medication is toxic to the retina and that is the cause of the vision damage.

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Elmiron Adds A Warning Label

Finally, a few weeks ago after rising pressure from the scientific community and consumers, Janssen Pharmaceuticals placed a warning label on the Elmiron packaging and on the drug’s website. The company states that if you are taking Elmiron you are advised to tell your doctor if you notice a change in your vision, particularly in the retina. However, vision issues are not listed as a common side effect.

What is most upsetting to learn is that based on the findings of the research conducted the European European Medicines Agency (EMA) requested in the summer of 2019 that the Elmiron packaging include a warning label to address the risk of vision damage. In October 2019 Health Canada followed suit and Janssen updated the warning labels of Elmiron in both of those Countries however, no mention of vision loss was placed on the U.S label of the drug until now.

The Future for IC Patients

Researchers have been studying other drugs as an alternate means to treat IC. For example, patients in a study who took Humira (adalimumab), which is typically prescribed for patients suffering from rheumatoid arthritis, had a “statistically significant improvement” in their IC. Women who participated in a study of tanezumab - a drug used to manage pain due to osteoporosis - also felt improvement, although the men who took part in the study did not.

Still, at the moment, Elmiron is the only approved drug on the market when it comes to treating IC. Patients who are concerned about the possible side effects to their vision should discuss this with their doctors to balance the risk and reward of the drug, and as always, patients should never stop taking a drug without talking to their physician first.

If you believe that you or a loved one’s vision has been impacted by using Elmiron, we invite you to fill in our form below to see if we can help you.

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Women Who Used Elmiron® For Bladder Discomfort: Compensation May Be Possible!

Elmiron Lawsuit Updates - 2023

  • July 1, 2023 - Log in to PACER for the latest filings on Master Docket No. 2:20-md-2973.
    The Presiding Judges:Judge Brian R. Martinotti, U.S.D.J.
    Judge Edward S. Kiel, U.S.M.J.
  • June 1, 2023 - National Institutes of Health (NIH) - Elmiron Management status report.
  • May 1, 2023 - Pentosan Polysulfate Sodium (Elmiron), maculopathy - a genetic perspective.
  • April 1, 2023 - Pentosan polysulfate sodium (Elmiron) maculopathy: a genetic perspective
  • February 19, 2023 - Medicaid - Arizona (AZM, AZMREF, AZMDDD) Elmiron Prior Authorization Guideline
  • February 1, 2023 - Warning about Elmiron - Retinal Pigmentary changes. Long-term use of Elmiron, which is known as Pigmentary Maculopathy in the literature, has been shown to cause Pigmentary changes in the retina. These cases were most common after three years or more of use, but some cases were seen with shorter periods of time.
  • January 15, 2023 - Serious side effects have been reported with the use of Elmiron.
  • January 1, 2023 - What Are Side Effects Associated with Using Pentosan Polysulfate Sodium?Common side effects of Pentosan Polysulfate Sodium include:
    • Abdominal pain
    • Depressed mood
    • Diarrhea Dizziness
    • Hair loss
    • Headache
    • Itching or skin rash
    • Nausea Stomach upset or pain

    Serious side effects of Pentosan Polysulfate Sodium include:

    • Discomfort when swallowing Heartburn
    • Mental/mood changes
    • Unusual bruising or bleeding
  • December 1, 2022 - Elmiron (Pentosan Polysulfate Sodium) common side effects update.
  • August 1, 2022 - U.S. District Court for the District of New Jersey - MDL No. 2973 - Elmiron (Pentosan Polysolfate Sodium) Products Liability Litigation Update (Judge Brian R. Martinotti & Judge Edward S. Kiel).
  • July 1, 2022 - U.S. District Court - District of New Jersey - Elmiron Case Management Orders Updates.
  • June 1, 2022 - The long term efficacy & safety of Elmiron in relieving recurring symptoms of interstitial cystitis were investigated in a long term, open label physician's usage study.
  • May 1, 2022 - Superior Court of New Jersey Law Division: Bergen County - Elmiron Products Liability Litigation: The parties shall continue to meet and confer regarding coordination and entry of proposed case management orders similar to those entered in, MDL No. 2973.
  • April 1, 2022 - U.S. District Court for the District of New Jersey - Elmiron (Pentosan Polysulfate Sodium) Products Liability Litigation MDL No. 2973
    Judge Brian R. Martinotti, Judge Edward S. Kiel - Elmiron have been filed and served (666 federal and 81 in state courts).
  • March 1, 2022 - Last month we have received over 210 inquiries on our site from people who used Elmiron and had vision problems.
  • January 2, 2022 - Elmiron & other drug removals for clients with advanced control specialty formulary - State of West Virginia Public Employees Insurance Agency.
  • November 2, 2021 - Brian R. Martinotti (U.S. District Judge, District of New Jersey) MDL-2973 - Elmiron (Pentosan Polysulfate Sodium) Products Liability Litigation
  • September 7, 2021 - Hon. Glenn A. Grant - Multicounty Litigation Application New Jersey State Court Litigation Involving Elmiron®. Anyone wishing to comment on or object to this application should provide such comments or objections in writing, with relevant supporting documentation, by October 10, 2021
  • August 2, 2021 - United States District Court - Elmiron Case Management Orders
  • January 22, 2021 - A diverse group of attorneys, mostly women will lead the counsel in the Elmiron MDL Lawsuit. The judge repeatedly asked for diverse representation as a majority of the plaintiffs are expected to be women
  • Due to Covid-19 Elmiron case management conferences in New Jersey have been held via Zoom on January, 8 2021.
  • September 25, 2020 - A Tennessee Couple Requests That All Elmiron Cases Be Combined. A filing by a couple requested that all the Elmiron product liability lawsuits be combined and sent to a New Jersey federal court to “guard against inconsistent rulings”.

  • July 13, 2020 - Janssen Pharmaceuticals added a warning label about Vision and Retinal Damage on their US Packaging of the label of Elmiron.

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About us

We are here to help you and loved ones advocate for justice. Feel free to send us any questions you might have, either about an injury or the process for pursuing justice so we can help you exercise your rights.

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© Copyright Jazz Media Ltd. 2020. All rights reserved