Elmiron Lawsuit

Experiencing side effects caused by the drug Elmiron?

Contact Lawyer One

If you or a loved one has a related case, please fill out the form below. If you wish to call our number is 1.800.391.0227.

Schedule your free consultation now
Free Consultation. Call Us 24/7.

Elmiron Side Effects

Elmiron, or pentosan polysulfate sodium, is a drug prescribed to patients for the treatment of interstitial cystitis, which is also known as “painful bladder disorder” (IC). This drug was approved by the Food and Drug Administration in 1996, which is the only approved oral medication that can treat this condition.

Interstitial Cystitis

Interstitial cystitis can cause bladder pressure and bladder and pelvic pain if not treated, and mostly affects women. The pain can occur intermittently or chronically and can range from mild discomfort to severe pain. IC is quite common and affects 1 to 4 million men and 3 to 8 million women in the United States. There is currently no cure for IC.

According to Janssen Pharmaceuticals, which is a division of the medical corporation Johnson & Johnson and a manufacturer of Elmiron, the price for Elmiron has been on the rise due to the lack of alternative medication for the treatment of interstitial cystitis. Due to increasing demand, many more people are paying escalating amounts to get their hands on this drug.

If you’ve taken the drug Elmiron and are experiencing maculopathy, vision problems or other side effects it is highly recommended that you see your physician immediately and then consult with an Elmiron lawyer. Upon knowing all the facts from your doctor and attorney, you can then best determine whether legal action against Janssen Pharmaceuticals, the manufacturer of the drug, is your best course of action.

As of this year, Janssen Pharmaceuticals updated their website with information listing vision damage as a potential side effect of using Elmiron. Janssen states that “pigment changes in the retina of the eye” may be a risk factor, and lists down the possible symptoms, such as blurry vision and trouble in seeing at low lighting.

What is the Elmiron Lawsuits about?

Short answer – maculopathy.

In Elmiron lawsuits, plaintiffs have accused Janssen Pharmaceuticals, manufacturer of Elmiron, of failing to fully disclose the dangers of taking Elmiron. In 2018, in a study by Dr. Nieraj Jain. from Emory Eye Center in Atlanta, six patients have developed maculopathy over the course of 16 years of exposure to Elmiron.

In another research by Kaiser Permanente in California, it was discovered that 25 percent of people who take the medication have experienced damage in their retinas. Also, further research concluded that the higher the dosage of Elmiron, the more toxic it is.

Plaintiffs argue that Janssen have failed to mention or warn about maculopathy or any vision damage on their list of side effects while they continued to market and manufacture the drug since the 2000s.

Use Form or Call 1.800.391.0227

Free Consultation. Call Us 24/7.

If you or a loved one has a related case, please fill out the form below to schedule a call.

Schedule your free consultation now

Alex Barlow Attorney at Law
Shrader & Associates
Houston, TX
More Info ...

You may have seen us mentioned in ...

Side Effects

Like many drugs, taking Elmiron comes with side effects. Patients who have taken Elmiron have reported to have experienced these common side effects:

  • Alopecia (hair loss)
  • Diarrhea
  • Nausea
  • Headache
  • Stomach or Abdominal pain
  • Dizziness

If you experience any of the more severe side effects below, it is advised to let your doctor know right away:

  • Bruising or bleeding (such as blood in stool)
  • Mental/mood changes
  • Heartburn
  • Discomfort when swallowing
  • Maculopathy (retinal issues)

While most of the common risks are mild and the severe risks are unlikely, more recent reports have recorded that the drug is severely harmful to the retina, which is the thin layer of tissue at the back of the eye that receives light. Taking Elmiron can lead to these retinal issues called maculopathy.


Maculopathy, otherwise known as macular degeneration, is a pathological disease that damages the macula, the central part of the eye’s retina. The macula is essential in helping you to read, see details, identify faces and colors, and more. There are multiple types of maculopathy, and here are some listed below:

Age related macular degeneration: the most common maculopathy that is progressive and occurs over time. It mainly affects people at the age of 50 or over, also making it the number one cause of vision loss in the United States.

Cellophane Maculopathy: also called macular pucker, is when a thin, transparent layer of tissue covers the inside of the retina, causing one to see distorted images.

The type of maculopathy that is linked with interstitial cystitis through Elmiron is pigmentary maculopathy. This form of maculopathy has no known cause, and it is reported that long-term use of Elmiron could lead to this retinal damage. Vision problem is usually the first symptom reported, and specifically signs that you may have maculopathy are:

  • Difficulty reading
  • Difficulty seeing close objects
  • Difficulty in adjusting in the dark or low lighting
  • Darkened vision

If you or someone you know have experienced these symptoms while taking Elmiron, it’s important that you seek immediate medical professional help. You may also be able to file an Elmiron lawsuit.

Elmiron Frequently Asked Questions (FAQ)
Is there an alternative for Elmiron?
No, Elmiron is currently the only FDA-approved drug used to treat IC.
Can Elmiron cause blindness?
In recent studies, researchers have found a link between the usage of Elmiron and maculopathy, which is permanent vision loss over time.
Can Elmiron cure Intersititial Cystitis?
No, Elmiron is not a cure for IC. Your doctor should only prescribe Elmiron if they see thatit is worth taking the risks.

Do I have a case?

Experiencing any damage to your vision, particularly maculopathy, due to the use of Elmiron is a good possibility for a case. You should consider consulting with our Elmiron lawyers if you find you have these or similar conditions.

Since the FDA’s approval of the drug, it’s been marketed as a safe medication that has been prescribed to hundreds of thousands of people with interstitial cystitis. With Elmiron being the only FDA-approved drug for an illness that has no cure, people have been willing to spend thousands of dollars for such medication that exposes them to a serious and irreversible eye condition. Yet, Janssen Pharmaceuticals has failed to hold themselves accountable for their misleading and harmful marketing.

Updated Information – June 2020

As of this year, Janssen Pharmaceuticals updated the information on the list of side effects with the warning of vision damage on their website. Janssen states that “pigment changes in the retina of the eye” may be a risk factor, and lists down the possible symptoms, such as blurry vision and trouble in seeing at low lighting. The information also suggests getting regular eye exams that includes retinal examinations for early detection of any macular damage. Finally, the new label states that the damages may be irreversible and may worsen even after stopping usage.

Reports and Lawsuits

Recently, on May 4, 2020, Tina Pisco a woman from Nevada filed a lawsuit against Janssen Pharmaceuticals after developing maculopathy since taking the drug in 2012. She started taking the drug to treat interstitial cystitis, and 6 years later, her eyesight had deteriorated quickly. In March 2019, Pisco had developed perpetual retinal injury in both of her eyes. Fourteen months later, Pisco filed a lawsuit against Janssen, in which she claims that Elmiron was “structured, promoted, and dispersed . . . while knowing noteworthy dangers that were never revealed to the clinical and social insurance network.” Pisco also claimed that Janssen Pharmaceuticals ““neglected to reveal the genuine connection between Elmiron use and noteworthy visual harm, including pigmentary maculopathy.”

What to do – Tips and Resources

If you’ve been prescribed Elmiron and have experienced maculopathy, vision damage, retinal injury or other serious and irreversible side effects, consult with our top-notch Elmiron lawyers who have the skills and experiences to seek compensation for these damages below:

  • Medical expenses
  • Physical and mental suffering
  • Loss of wages and earnings
  • Emotional distress

Seek medical attention immediate from your doctor or provider and follow their orders and recommendation in order to reduce further worsening of symptoms. Talk to them about alternative treatments.

When filing for a lawsuit, your Elmiron lawyer will help you gather evidence to support your claims and help determine liability. Many of these lawsuits are seeking for a refund of the faulty product or fraudulent service. They are seeking to create a fund that would help out patients who are in need of regular eye checkups. A reminder: each state has a statue of limitations that restricts the amount of time you have to take legal action after you first developed symptoms, so contact one of our Elmiron lawyers right away.

Understanding Elmiron, Interstitial Cystitis, and Pigmentary Maculopathy

Every medication comes with side effects. Physicians and patients have a careful discussion together and only start a medication if the potential benefits outweigh the risks. For example, you would take your Statin medication knowing it reduces your chance of heart attacks and cardiovascular disease despite the hazard of muscle aches. But what if you were considering a medication for which you and your physician did not fully understand the risks of?

Interstitial Cystitis

Elmiron was initially developed for the treatment of interstitial cystitis, a chronic pain syndrome. The condition causes bladder or pelvic pain as well as frequent urination which can have a significant impact on the quality of life for patients. While the exact mechanism of interstitial cystitis is still not yet understood, it may be more common than you think; studies indicate it impacts between 1 and 5.1 out of 100,000 people and possibly up to 12% of women.

Treatment typically begins with lifestyle management and behavioral modification including managing one’s fluid intake and avoiding foods, beverages, or activities that worsen symptoms. In patients for whom these interventions are ineffective, pharmacological management may be considered. Amitriptyline, an anti-depressant, is used off label as the first line medication by many physicians because it has been found to be an effective pain reliever. At higher doses however, it can cause bothersome side effects including dry mouth, urinary retention, low blood pressure, and constipation. There was a need for other medical options for patients.

Elmiron—A New Treatment

Elmiron (Pentosan polysulfate sodium) is manufactured by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson. It was approved by the U.S. Food and Drug Administration in 1996 for the treatment of interstitial cystitis. It is structurally related to the blood thinner heparin and was found to adhere to the bladder wall but the exact mechanism by which it improves the symptoms of interstitial cystitis is not yet known. Two clinical trials were used in the FDA approval of the medication and involved the study of 151 patients over the course of 3 months and nearly 2500 patients over the span of 1 year respectively. Subsequent studies have similarly found Elmiron to improve symptoms in patients although its overall effect is likely somewhat limited. A 2019 meta-analysis of multiple studies found an overall 12% improvement in bladder pain and urinary symptoms in patients.

It has been reported that hundreds of thousands of patients have or are currently still taking the medication. It is important to recognize that the initial referenced studies used in the medication approval process only involved a couple thousand people studied for up to 1 year. When it was first marketed, listed side effects included headache, nausea, diarrhea, and minor bleeding. Long term adverse reactions would not have been disclosed because they were not yet known about because patients had only been studied for 1 year. Post-approval surveillance monitoring as more patients started to take Elmiron several years out suggests that some may be at risk of serious ophthalmological risk that could permanently impact their vision.

Pigmentary Maculopathy and Elmiron

The macula is the central area of the retina and is an important structure of the eye that is responsible for sensing light. Any damage to the macula impacts the ability to see with clarity and color. Disease of the macula is called “maculopathy” and is actually somewhat common. Age-related macular degeneration is the leading cause of adult blindness in the United States. One subtype involves lesions and deposits are found in the macula while the other subtype involves abnormal growth of blood vessels in the retina. In both cases, the addition of these structures crowd out the macula and impair its ability to sense light and, therefore, the ability to see.

Pigmentary maculopathy was first reported in a case series of 6 patients who had been taking Elmiron for several years in 2018. It is described as a unique disease entity in which pale yellow or orange deposits are found in the macula and also block the passage of light. The mechanism for the deposits is not yet fully understood but it has been proposed that either Elmiron or one of its metabolites deposit within the eye like it does in the bladder. It may be difficult to tell the difference between pigmentary maculopathy and age-related macular degeneration on physical exam. It is possible that there are many patients who were erroneously diagnosed with age-related macular degeneration when they actually had pigmentary maculopathy as the two can present with similar symptoms.

More recent studies have continued to demonstrate a possible correlation between pigmentary maculopathy and Elmiron. A Kaiser Permanente Northern California study published in June 2020 examining 475 patients taking Elmiron found an association between dose size and the risk of developing macular disease. Overall about 25% of patients taking >500 grams of medication daily and nearly 42% in the highest consumption group had findings consistent with pigmentary maculopathy. In their study, Elmiron was the only statistically significant factor associated with the maculopathy despite accounting for age, gender, race, weight, and other demographic data.

While studies are still limited, there seems to be a growing body of evidence confirming an association between Elmiron and the development of ophthalmological side effects. Of note, it is still not known to what degree genetics or other factors may be contributing nor what the exact prevalence of ocular side effects are. Janssen Pharmaceuticals now recommends patients who take Elmiron should receive regular eye and retinal examinations.

Understanding the Risks

Even after stopping Elmiron, pigmentary maculopathy has been observed to continue to progress and vision may worsen. Treatment options, beyond cessation of the medication, are unfortunately somewhat limited at this time. The exact degree of risk associated with Elmiron will hopefully be better elucidated as more studies are conducted. Knowing this, how would your discussion with your physician change if you were considering starting Elmiron? Do you think you have been affected by it?

About Elmiron

Join us as we speak with Senior Counsel, Alex Barlow, from the law firm of Shrader & Associates. In this interview we discuss details related to Elmiron litigation and the potential problematic actions taken by the drug's manufacturer, Janssen Pharmaceuticals.

Alex Barlow

Senior Counsel, Shrader & Associates

About Alex Barlow

Alex Barlow has devoted his practice to complex litigation on behalf of injury victims. Alex considers himself fortunate to have tried and won cases on behalf of a diverse spectrum of plaintiffs – ranging from workingmen stricken with mesothelioma all the way to Fortune 500 companies.

Alex has represented the Attorneys General of eight states against large pharmaceutical companies over the mismarketing of their drugs. Alex also served as counsel for thousands of men and women who suffered cardiovascular injuries due to complications from certain drugs. Alex is currently exploring cases related to TDF drug injuries due to the negligence of their creators.

Law Firm Information
Firm: Shrader & Associates L.L.P.
Address: 9 Greenway Plaza
Suite 2300
Houston, TX 77046
Phone: 1.800.391.0227
Shrader & Associates Office
Lauren Testimonial
Bill Testimonial
Tom Testimonial
Edith Testimonial
Beth Testimonial

Latest Videos

View All Videos ...
Call Us Book Appointment Text Us