Several lawsuits have been filed on behalf of individuals who took the drug Elmiron and later developed debilitating eye conditions. What should people know about this medication, what it was designed to treat and what rights they have if they’ve taken the drug and later had vision problems?
What Is Elmiron?
Elmiron, the brand name for pentosan polysulfate sodium, is manufactured and marketed by Janssen Pharmaceuticals (a subsidiary of Johnson & Johnson), Bayer AG, and Teva Branded Pharmaceuticals. The medication is prescribed to treat the pain associated with interstitial cystitis, which is a bladder disorder that cause severe pain in some patients.
Elmiron is the only drug that’s been approved by the U.S. Food and Drug Administration (FDA) to treat the pain associated with interstitial cystitis (IC), which means that many patients who previously were experiencing severe pain because of the disorder may have taken the drug in hopes of having their discomfort relieved.
Symptoms of IC, which can affect both men and women, include:
- Sudden pelvic pain
- Pain between genitals and anus
- Chronic pelvic pain
- Persistent need to urinate
- Frequent urination often of small amounts
- Pain during sex
- Relief of pain after urinating
Because the symptoms can mimic those commonly present during a urinary tract infection, diagnosis of IC can be difficult or delayed. It’s unknown what the precise cause is of IC, but the condition is more common in women than in men. Additionally, those with fair skin and red hair have been diagnosed at higher rates, and people with existing chronic pain disorders like fibromyalgia may be more prone to IC.
If left untreated, IC reduces bladder capacity, as well as interfering with many aspects of a good quality of life, such as engaging in social activities, work, and sex. And the chronic, often severe pain experienced by those with the condition can cause long-term emotional problems like depression.
Elmiron is believed to help those with IC by restoring the surface of the bladder, strengthening the organ, and protecting it from irritating substances found in urine. The precise mechanism that causes this reaction isn’t known, but drug trials for Elmiron were 61% effective at improving IC pain and discomfort.
Elmiron Links to Eye Damage
Janssen, one of the companies that makes Elmiron, lists among the side effects of the drug vision changes related to pigment changes in the retina. According to the company, patients have reported visual symptoms like blurred vision, difficulty reading, and slow adjustment to low-light environments. Other common side effects include headaches, nausea, diarrhea, and abdominal pain. These types of side effects are common with many drugs, but Elmiron has also been connected to much more serious complications.
Severe and often permanent side effects reported by former Elmiron patients include:
- Permanent retinal injury
- Vision loss
- Night vision loss
- Pigmentary maculopathy
- Blind spots
- Blurry vision
- Halo vision
- Difficulty with up-close vision
- Inability to see letters when reading
More recent studies on the connection between Elmiron and vision loss indicated that between 8% and 24% of those taking Elmiron, particularly for long stretches of time, experienced maculopathy. This is another term for macular degeneration, which is one of the leading causes of blindness and visual impairment.
Those who took Elmiron, especially those who took the drug for many years, should consult with an eye doctor to have a full vision exam, even if they aren’t currently experiencing visual side effects. Damage related to Elmiron may well be permanent, so it’s important to ensure that you don’t have early stages of this damage that may not result in noticeable symptoms.
While Elmiron has been on the market since 1996, Janssen Pharmaceuticals did not update the drug’s warning label to include vision problems until 2020. By that time, thousands of people had been taking the drug for as long as 15 years to treat chronic bladder pain.
More than 100 lawsuits have been filed so far against Janssen, and about 130 of them have been condensed into a multijurisdictional litigation (MDL) in New Jersey. This type of litigation is similar to a class action, but one of the biggest differences is that cases consolidated in MDLs proceed through the court system on their own merit. This differs from major class actions that consumers may simply join.
For those who took Elmiron and later developed vision problems, there’s currently only one way to seek compensation for your damages, and that’s by filing a lawsuit against Teva, the company that owns the licensing rights to Elmiron, and/or Janssen Pharmaceuticals and Bayer, which both make and market the drug.
Here’s a look at some of the questions readers most frequently ask about Elmiron and lawsuits related to the drug:
Does Elmiron cause blindness?
In recent studies, between 8% and 24% of people who took Elmiron experienced maculopathy or macular degeneration. While this does not cause blindness in 100% of people who are diagnosed with it, macular degeneration is one of the most common causes of permanent vision loss in the world. It’s far more common for older people, and age-related macular degeneration is expected to impact about 22 million Americans by 2050. However, studies have indicated that many patients taking Elmiron have suffered macular degeneration unrelated to any other cause than their use of the medication.
Why do patients continue taking Elmiron?
The primary use of Elmiron is to treat the pain associated with interstitial cystitis (IC), which is a chronic bladder condition that causes frequent urination and discomfort. It’s not known why the drug helps alleviate the pain associated with this condition, but the medication is unlike as-needed pain relievers in that it must be taken continuously for the desired effect to be realized. In other words, patients must continue taking Elmiron if they want to see the benefits in reduced bladder and urinary pain or discomfort.
Should I stop taking Elmiron?
If you have been prescribed Elmiron (pentosan polysulfate sodium) for a chronic bladder condition called interstitial cystitis (IC), you should consult with both the doctor who prescribed the medication as well as an eye doctor. There is currently no other medication approved to treat the often-severe pain associated with IC, and it may be inadvisable to stop taking the medication abruptly. Consulting with the doctor who treats your IC is the best way to be sure you’re being safe and responsible, but if you have experienced damage to your retina, it’s likely that damage won’t be reversible. Still, it’s important that you also consult with an eye doctor, who can provide a thorough examination of your vision and the physical state of your eyes, including the retina and macula.
Is there a class action lawsuit over Elmiron?
No, currently there are more than 100 lawsuits that have been filed in connection with the IC drug Elmiron, but there hasn’t been a class action established yet. However, a multijurisdictional litigation (MDL) has been established in New Jersey. The two types of lawsuits are similar, but with MDL lawsuits, cases proceed through the court system largely on their own merit. That means it’s important to have a qualified attorney on your side if you have been impacted by Elmiron. More cases are being filed all the time, so a class action may be established in the future.
What allegations are part of Elmiron lawsuits?
In addition to claims that the drug caused permanent vision damages, patients filing lawsuits against Janssen Pharmaceuticals have alleged that the company withheld from the American public evidence that Elmiron can cause retinal maculopathy and other vision problems. Until 2020, the drug’s warning label did not reference any side effects related to vision, but according to one of the lawsuits filed against Janssen, the company’s Canadian warning label listed maculopathy as a possible side effect of prolonged use of the drug.
Have Your Elmiron Case Evaluated for Free
If you were prescribed Elmiron to treat interstitial cystitis (IC), you may be at risk of permanent vision problems, including macular degeneration, which can lead to blindness. Regardless of whether you’re experiencing vision loss now, you should seek a consultation with an eye doctor to ensure no damage to your vision has occurred. If it has, you may be entitled to seek financial compensation. For a free evaluation of your case, contact the Law Office of Melinda J. Helbock by filling out the form on this page.
U.S. National Library of Medicine, National Institutes of Health, PubMed, Possible drug-induced, vision-threatening maculopathy secondary to chronic pentosan polysulfate sodium (Elmiron) exposure. (2020.) Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7012292/
Interstitial Cystitis Association, Pentosan Polysulfate Sodium. (2015.) Retrieved from https://www.ichelp.org/diagnosis-treatment/treatments/pentosan-polysulfate-sodium/
American Academy of Ophthalmology, Pigmentary Maculopathy From Chronic Exposure to Pentosan Polysulfate Sodium. (2018.) Retrieved from https://www.aao.org/interview/pigmentary-maculopathy-from-chronic-exposure-to-pe
BrightFocus Foundation, Age-Related Macular Degeneration: Facts & Figures. (2019.) Retrieved from https://www.brightfocus.org/macular/article/age-related-macular-facts-figures
U.S. Food and Drug Administration, Elmiron 100MG drug label. (2020.) Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020193s014lbl.pdf