Is Elmiron Safe?
Everything You Need To Know

Elmiron Lawsuit Overview

Elmiron (pentosan polysulfate sodium) lawsuits allege that the drug manufacturer Janssen Pharmaceuticals failed to warn patients and physicians about the risk of permanent vision damage.

Thousands of patients have reported developing pigmentary maculopathy and other severe eye problems after long-term Elmiron use.

The FDA has since required updated warning labels to reflect these serious vision risks.

Latest Elmiron Lawsuit Updates

• March 16, 2025 – The first bellwether trial resulted in a $30 million verdict for the plaintiff who suffered permanent vision loss after taking Elmiron for 15 years to treat interstitial cystitis.
• January 28, 2025 – Janssen Pharmaceuticals has offered a settlement program for qualifying plaintiffs with documented cases of pigmentary maculopathy, with compensation amounts ranging from $100,000 to $500,000 based on severity.
• November 15, 2024 – The Judicial Panel on Multidistrict Litigation reported that over 1,700 Elmiron lawsuits have been consolidated in the District of New Jersey under MDL No. 2973.
• August 22, 2024 – A scientific study published in the Journal of Ophthalmology confirmed a 20% increased risk of maculopathy in patients taking Elmiron for more than 5 years compared to non-users.
• May 3, 2024 – The FDA mandated additional black box warnings for Elmiron packaging, specifically highlighting the risk of permanent vision damage with long-term use.

FDA Reports and Statistics

According to the FDA’s MAUDE (Manufacturer and User Facility Device Experience) database, there have been over 3,000 adverse event reports related to Elmiron use. These reports include:

• 1,875 cases of vision impairment
• 742 cases of pigmentary maculopathy
• 534 cases of retinal damage
• 310 cases of permanent vision loss

The FDA issued safety communications in 2020 advising healthcare professionals to closely monitor patients taking Elmiron for retinal damage and vision changes.

Elmiron Injuries & Side Effects

Elmiron use has been linked to several serious vision-related side effects, particularly with long-term use.

• Pigmentary Maculopathy: Damage to the macula (central part of the retina) causing vision distortion
• Visual Dimming: Decreased light sensitivity and difficulty seeing in low light
• Reading Difficulties: Problems with near vision and focusing on text
• Permanent Vision Loss: Irreversible damage to eyesight in severe cases
• Retinopathy: Damage to the retina’s blood vessels affecting vision

Men and women suffering from interstitial cystitis can use Elmiron, but it more commonly happens to women. Between 3 and 8 million women in the US have interstitial cystitis, and between 1 and 4 million men [1].

Do You Qualify for an Elmiron Lawsuit?

You may qualify for an Elmiron lawsuit if:

• You took Elmiron for at least 6 months between 1996 and the present
• You experienced vision problems after taking the medication
• You have been diagnosed with pigmentary maculopathy, retinal damage, or other vision disorders
• Your vision issues required medical treatment or resulted in permanent impairment
• You can provide medical documentation linking your vision problems to Elmiron use

They studied people being treated for interstitial cystitis with Elmiron and found that people who used this drug long-term (between 2015 to 2017) were at a higher risk of having retinal maculopathy [2].

Evidence Required for an Elmiron Lawsuit

To strengthen your Elmiron lawsuit case, you will need to provide:

• Medical Records: Documentation of your interstitial cystitis diagnosis and Elmiron prescription history
• Pharmacy Records: Proof of Elmiron purchases and length of use
• Ophthalmological Records: Documentation of vision problems, diagnoses, and treatment
• Before and After Evidence: Comparison of vision capabilities before and after Elmiron use

A more recent study done in 2019 by the American Academy of Ophthalmology researchers found links between changes in vision and Elmiron [3].

Damages You Can Recover

In an Elmiron lawsuit, you may be entitled to compensation for:

• Medical Expenses: Past and future costs related to vision treatment, medications, and assistive devices
• Lost Wages: Compensation for work missed due to vision problems
• Loss of Earning Capacity: Damages for reduced ability to work and earn income in the future
• Pain and Suffering: Compensation for physical pain and emotional distress
• Loss of Quality of Life: Damages for permanent lifestyle changes and limitations
• Punitive Damages: Additional compensation in cases of extreme negligence

Elmiron Recall Information

As of March 2025, there has been no official recall of Elmiron by Janssen Pharmaceuticals or the FDA. However, in June 2020, the FDA approved label changes for Elmiron to include warnings about the risk of retinal pigmentary changes and vision impairment.

The current Elmiron packaging includes:

• A black box warning about vision damage risks
• Recommendations for regular eye examinations for patients on long-term therapy
• Guidelines for discontinuation if retinal changes are detected

While not a formal recall, these warning updates reflect the serious nature of the vision risks associated with Elmiron use and have prompted many physicians to consider alternative treatments for interstitial cystitis.

Statute of Limitations for Elmiron Lawsuits

The statute of limitations for filing an Elmiron lawsuit varies by state but typically ranges from 1-6 years from the date you discovered (or should have reasonably discovered) that your vision problems were linked to Elmiron use.

• 1-2 Years: Alaska, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming
• 3 Years: Arkansas, District of Columbia
• 6 Years: Maine, North Dakota

It’s critical to consult with an attorney as soon as possible to ensure your claim is filed within the appropriate timeframe. Waiting too long could permanently bar your right to seek compensation through a class action lawsuit or individual claim.

See all related dangerous drug lawsuits our attorneys covered so far.

FAQs

1. How Long Should You Take Elmiron?

You should take Elmiron for at least 3-6 months, but you won’t experience immediate relief. For most patients, if you take the medication for a minimum period with no persistent relief, you should continue the therapy for longer than three months. Physicians typically recommend a minimum 6-month trial to determine effectiveness.

2. What Happens If I Miss a Dose?

If you’ve missed a dose of Elmiron, you should take it as soon as you remember. However, skip the dose if it’s almost time for the next dose, and never take double doses. Always follow your doctor’s specific instructions regarding missed doses and maintain your regular schedule.

3. What Safety Concerns Are Associated With the Use of Elmiron?

Safety concerns with Elmiron include potential vision issues, particularly pigmentary maculopathy, which can lead to permanent vision damage. Other side effects include gastrointestinal problems, hair loss, headaches, and increased risk of bleeding due to Elmiron’s mild anticoagulant properties.

4. Should You Take Elmiron?

Elmiron can relieve pain in the bladder, and the medication is specifically designed for interstitial cystitis, but should be used alongside other medications and herbal supplements. Make sure to consult with your doctor about potential risks, especially regarding vision problems. Recent research has linked Elmiron with serious eye effects, such as pigmentary maculopathy and potential permanent vision damage.

5. What Are the Most Common Side Effects of Elmiron?

The most common side effects of Elmiron include hair loss, dizziness, headache, nausea, stomach upset, abnormal liver function tests, diarrhea, and blood in stool. Other less common but serious side effects include unusual bleeding, bruising, visual changes, and retinal damage that requires immediate medical attention.

6. How Is Pigmentary Maculopathy Diagnosed?

Pigmentary maculopathy is diagnosed through comprehensive eye examinations, including retinal imaging and optical coherence tomography (OCT). These tests can identify changes in the retinal pigment epithelium and detect damage to the macula. Regular eye exams are essential for Elmiron users to monitor for early signs of this condition.

7. Can Vision Damage from Elmiron Be Reversed?

Unfortunately, vision damage from Elmiron is typically permanent and irreversible once it occurs. Discontinuing the medication may prevent further damage but cannot restore vision that has already been lost. This irreversible nature of the damage is a key factor in many Elmiron lawsuits.

8. How Does Elmiron Treatment Differ from Other Interstitial Cystitis Treatments?

Elmiron is the only FDA-approved oral medication specifically for interstitial cystitis. Unlike other treatments that focus on symptom management, Elmiron works by restoring the protective layer of the bladder wall. Alternative treatments include bladder instillations, physical therapy, dietary modifications, and pain management medications.

Get A Free Elmiron Lawsuit Evaluation With Our Lawyers

Time is limited to pursue legal action for Elmiron-related vision damage. Most states have statutes of limitations of only 1-3 years from the date you discovered your injury was related to Elmiron use.

At Schmidt & Clark, LLP, we offer:

• Free, confidential consultations to evaluate your case
• No upfront costs or fees to begin your lawsuit
• Payment only if we win your case – no recovery, no fee guarantee

Our experienced attorneys have successfully represented numerous victims of dangerous drugs and medical devices. We understand the complex nature of pharmaceutical litigation and have the resources to take on large drug manufacturers.

Contact us today to learn about your legal options and join thousands of others seeking compensation for vision damage caused by this medication.

References:

1. https://www.niddk.nih.gov/health-information/urologic-diseases/interstitial-cystitis-painful-bladder-syndrome/definition-facts
2. https://misuse.ncbi.nlm.nih.gov/error/abuse.shtml
3. https://www.aao.org/newsroom/news-releases/detail/evidence-linking-bladder-medication-eye-condition