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Elmiron Lawsuits

Elmiron lawsuits claim the drug causes an eye disorder called maculopathy and other disorders of the retina that may lead to blindness. People who took Elmiron and suffered maculopathy or other serious vision problems may be eligible to file an Elmiron lawsuit.

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Plaintiffs in Elmiron lawsuits accuse Janssen Pharmaceuticals of failing to properly warn the public about the risk of vision problems. Recent studies linked the interstitial cystitis (IC) drug, also known as pentosan polysulfate sodium (PPS), to ocular toxicity and irreversible vision damage.

Research presented at the American Academy of Ophthalmology in 2019 by Drs. Robin A. Vora, Amar P. Patel, and Ronald Melles revealed that patients taking Elmiron showed clear signs of toxicity.

“It’s unfortunate,” Vora said in an American Academy of Ophthalmology news release. “You have a patient with a chronic condition like interstitial cystitis, for which there is no cure and no effective treatment. They get put on these medications because it’s thought to have few side effects and few risks, and no one thinks about it again. And year after year, the number of pills they’re taking goes up and up.”

“We believe that our findings add strong support to the growing body of evidence that links long-term PPS use to the potential development of a toxic maculopathy.”

Drs. Robin A. Vora, Amar P. Patel, and Ronald Melles

In January 2020, Drs. Vora, Patel, and Melles published a follow-up study of 117 patients in Ophthalmology.

“We believe that our findings add strong support to the growing body of evidence that links long-term PPS use to the potential development of a toxic maculopathy,” the authors said.

The drug has been on the market since the late 1990s, and it is the only drug approved to treat pain associated with interstitial cystitis, or IC — a condition that affects millions of Americans each year. IC is more prevalent in women, and many use Elmiron long term to treat the disease.

Hundreds of thousands of people may have taken the drug and may have been exposed to the risk of potentially permanent vision damage.

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Maculopathy and Pentosan Polysulfate Sodium

Prior to June 2020, Elmiron’s prescribing information provided by Janssen Pharmaceuticals listed the drug’s side effects and warnings but did not warn about the risks of retinal pigmentary maculopathy. The current prescribing information lists a warning about retinal pigmentary changes.

Starting in 2018, studies began to document irreversible vision problems associated with long-term use of Elmiron.

The macula is the backside of the retina. The retina senses light and sends a signal to the brain, allowing people to see. Retina damage affects a person’s vision. In the Western world, maculopathy is the most common cause of blindness.

Anatomy of an Eye
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Elmiron may cause damage to a part of the retina called the macula, causing vision problems.

The type of maculopathy linked to Elmiron is called pigmentary maculopathy. According to studies, this type of maculopathy seems to be unique to Elmiron users.

If caught in its early stages, the damage may stop after taking medication. But in late stages, the disease can lead to permanent vision loss. So far, researchers have reported on one patient whose eye damage continued for years even after stopping Elmiron.

The most common visual symptoms reported in studies were difficulty reading and difficulty adapting to dim lighting.

Symptoms Associated with Elmiron Damage in Studies:
  • Areas of vision loss in the field of vision, paracentral scotoma
  • Difficult time adjusting to dim lighting or the dark
  • Having a hard time reading
  • Problems seeing objects that are close
  • Vision dimming
Timeline of Studies
  • May 2018
    Dr. William A. Pearce and colleagues at the Emory Eye Center published results of a case study of six adult patients who took pentosan polysulfate sodium for IC in Ophthalmology. They found chronic exposure to the drug caused unique pigmentary maculopathy — specifically, injury to the retinal pigment epithelium, a layer of cells that nourishes the retina.
  • April 2019
    Doctors at Emory Eye Center published an expanded study of 10 patients in the Journal of Urology. Researchers noted that patients with a history of IC who did not take pentosan polysulfate sodium did not have the unique form of pigmented maculopathy present in patients who took the drug. They recommended that patients with signs of damage stop taking Elmiron and patients without symptoms undergo an ophthalmic examination with retinal imaging.
  • October 2019
    Researchers at Kaiser Permanente found 140 patients who had taken about 5,000 pentosan polysulfate sodium pills over the course of 15 years. Of those patients, 91 agreed to be examined. Twenty-two out of those 91 patients had signs of toxicity. The toxicity was greater in patients who took more of the drug — 11 percent in patients taking 500 to 1,000 grams and 42 percent in patients taking 1,500 grams or more.
  • November 2019
    Dr. Neiraj Jain and colleagues published a cohort study of data from a large United States medical claims database from 2002 to 2016 in the British Journal of Ophthalmology. They followed data from two groups of pentosan polysulfate sodium users: one group of 3,012 at 5 years and the second group of 1,604 at 7 years. They found pentosan users had significantly increased odds of macular disease at 7 years.
  • November 2019
    Drs. Rachel M. Huckfeldt and Demetrios G. Vavvas published a case report in Ophthalmic Surgery, Lasers and Imaging Retina. They presented the case of a patient whose pentosan-associated maculopathy continued to get worse 6 years after stopping the medication.
  • January 2020
    Drs. Robin A. Vora, Amar P. Patel, and Ronald Melles looked at data for 117 patients with IC who took PPS and found 27 had definite signs of maculopathy. Those who took more than 1,500 g had the highest risk of toxicity. Authors said their findings provided “strong support” to previous studies that linked long-term use of Elmiron to toxic maculopathy.

Status of Lawsuits

The Elmiron litigation is still in the beginning stages. So far, there are about 50 cases pending in federal and state courts across the United States as of September 2020.

In the next 12 months, plaintiffs and defendants expect Judge Wendy Beetlestone to move forward with discovery, lawyer Trent B. Miracle with Simons Hanly Conroy told Drugwatch. Currently, Beetlestone oversees the federal cases and is expected to oversee cases nationally.

Because tens of thousands of people potentially took Elmiron, attorneys expect the litigation to grow.

“Given the universe of patients on Elmiron and the relatively unique nature of the injuries here, plaintiffs expect that the universe of cases to ultimately increase to approximately 1,000 cases,” Miracle said.

Will There Be a Recall?

Elmiron has not been recalled despite studies linking long-term use of the IC drug to potentially permanent vision damage.

“In 2018, eye physicians published the first report of retinal damage associated with Elmiron use,” Miracle said. “Since then, the medical literature regarding eye damage and vision loss associated with Elmiron continues to grow.”

Janssen added a warning in June 2020. The FDA published the new label with the maculopathy warning but has not issued a statement or safety communication about it.

As of September 2020, the agency has not mentioned plans to request that Janssen recall the drug.

Do I Qualify for an Elmiron Lawsuit?

Lawyers are accepting cases from people who took Elmiron for at least two years and suffered vision problems, especially if they were still using Elmiron from 2018 to present.

These vision problems must have started while taking Elmiron or within one year of stopping treatment. For example, if you stopped taking Elmiron in 2010 and got a diagnosis of an eye condition in 2011, you may qualify.

Injuries in lawsuits include:
  • Blurred vision
  • Degenerative maculopathy
  • Halo vision
  • Macular retinopathy
  • Macular/pattern dystrophy
  • Maculopathy
  • Metamorphopsia
  • Pigmentary maculopathy
  • Reduced night vision
  • Retinal pigment epithelium atrophy
  • Retinopathy
  • Scotoma
  • Unilateral or bilateral blindness
  • Vision impairment
  • Vision loss

Questions Elmiron Lawyers May Ask You

When you contact a lawyer about your potential Elmiron vision damage case, they may ask you questions about your experience with the drug. Make sure you answer questions with as much detail as possible.

What injuries have you experienced?
People filing Elmiron lawsuits have typically been diagnosed with maculopathy, retinopathy or vision problems. Your medical records will help your attorney confirm the diagnosis.

When did your vision problems begin?
Knowing when you first started experiencing vision problems may help your lawyer accurately draw the connection between your vision problems and your Elmiron use. Generally, individuals seeking compensation for their injuries were diagnosed with vision problems either while they were taking Elmiron or within one year of stopping the medication.

Do your vision problems affect your day-to-day activities?
Be open with your attorney about how your vision problems have impacted your ability to do certain daily activities. He or she will also want to know about the emotional toll these vision problems have taken on you.

How long did you take Elmiron?
Vision problems have been linked to long-term exposure to the drug. The majority of Individuals filing Elmiron lawsuits had taken the drug for at least two years prior to experiencing vision problems.

Do you or your family have a history of eye problems?
Your lawyer will ask about your medical history to determine whether you may be prone to vision problems. Have copies of your medical records on hand.

What treatment did your medical provider recommend for your vision problems?
Bring any medications you’re currently taking for your vision problems. Your attorney will want to know if your vision problems have improved as a result of this treatment.

What prognosis did your medical provider give you?
Be prepared to discuss what your medical provider told you about the chances of regaining your vision and if symptoms would improve over time.

There may be a time limit to file your case, so you should contact an attorney as soon as you can. There is no charge to contact a lawyer about a potential Elmiron vision damage case.

Connecticut Woman Files Elmiron Lawsuit for ‘Permanent Retinal Injury’

On March 26, 2020, Kimberly Pelczar filed a lawsuit against Teva Pharmaceuticals USA Inc. and Johnson & Johnson’s subsidiary Janssen Pharmaceuticals because of vision loss she claims resulted from Elmiron.

In 2005, Pelczar began taking Elmiron for IC. In 2015, she began to suffer eye problems. From 2015 to 2019, she saw medical providers for her visual symptoms.

In 2019, medical providers diagnosed her with permanent retinal injury and vision loss because of Elmiron toxicity.

The complaint said drugmakers failed to properly warn physicians and the public that Elmiron could cause vision problems and claims drugmakers actively hid the side effects from the public.

Elmiron Pill
Elmiron Lawsuit Facts
  1. Defendant Janssen Pharmaceuticals, subsidiary of Johnson & Johnson
  2. Injuries in Lawsuits Maculopathy, retinopathy and other vision problems
  3. Status Beginning stages of litigation

Please seek the advice of a medical professional before making health care decisions.

Michelle Llamas, Senior Content Writer
Written By Michelle Llamas Senior Writer

Michelle Llamas has been writing articles and producing podcasts about drugs, medical devices and the FDA for nearly a decade. She focuses on various medical conditions, health policy, COVID-19, LGBTQ health, mental health and women’s health issues. Michelle collaborates with experts, including board-certified doctors, patients and advocates, to provide trusted health information to the public. Some of her qualifications include:

  • Member of American Medical Writers Association (AMWA) and former Engage Committee and Membership Committee member
  • Centers for Disease Control and Prevention (CDC) Health Literacy certificates
  • Original works published or cited in The Lancet, British Journal of Clinical Pharmacology and the Journal for Palliative Medicine
Edited By
Legally Reviewed By
Trent B. Miracle, Attorney at Simmons Hanly Conroy
Trent B. Miracle, Esquire Trial Attorney and Pharmaceutical Litigation Expert

10 Cited Research Articles

Drugwatch.com writers follow rigorous sourcing guidelines and cite only trustworthy sources of information, including peer-reviewed journals, court records, academic organizations, highly regarded nonprofit organizations, government reports and interviews with qualified experts. Review our editorial policy to learn more about our process for producing accurate, current and balanced content.

  1. American Academy of Ophthalmology. (2019, October 12). More Evidence Linking Common Bladder Medication to a Vision-threatening Eye Condition. Retrieved form https://www.aao.org/newsroom/news-releases/detail/evidence-linking-bladder-medication-eye-condition
  2. Dodson, P. (2008). Diabetic Retinopathy (Oxford Diabetes Library): Screening to Treatment. Retrieved form https://oxfordmedicine.com/view/10.1093/med/9780199544967.001.0001/med-9780199544967-chapter-6
  3. Foote, J., Hanif, A. & Jain, N. (2019, April 1). MP47-03 Chronic Exposure To Pentosan Polysulfate Sodium Is Associated With Retinal Pigmentary Changes And Vision Loss. Retrieved from https://www.auajournals.org/doi/10.1097/01.JU.0000556315.46806.ca
  4. Huckfeldt, R.M. & Vavvas, D.G. (2019, November 6). Progressive Maculopathy After Discontinuation of Pentosan Polysulfate Sodium. Retrieved from https://www.healio.com/ophthalmology/journals/osli/2019-10-50-10/%7B324bde2e-2389-4815-bf5e-fe3b2eb18062%7D/progressive-maculopathy-after-discontinuation-of-pentosan-polysulfate-sodium
  5. IC Network. (n.d.). Long-Term Pentosan (Elmiron) Use May Be Linked to Eye Disease. Retrieved from https://www.ic-network.com/long-term-pentosan-elmiron-use-may-be-linked-to-retinal-disease/
  6. Jain, N. et al. (2019, November 6). Association of macular disease with long-term use of pentosan polysulfate sodium: findings from a US cohort. Retrieved from https://bjo.bmj.com/content/early/2019/11/06/bjophthalmol-2019-314765
  7. Pearce, W.A., Chen, R. & Jain, N. (2018). Pigmentary Maculopathy Associated with Chronic Exposure to Pentosan Polysulfate Sodium. Retrieved from https://www.ncbi.nlm.nih.gov/pubmed/29801663
  8. Pelczar vs. Teva Branded Pharmaceutical Products R&D et al. (2020, March 26). United States District Court District Of Connecticut. Complaint. Case 3:20-cv-00406. Retrieved from https://aboutlawsuits-wpengine.netdna-ssl.com/wp-content/uploads/2020-03-26-Complaint.pdf
  9. Vora, R.A., Patel, A.P. & Melles, R. (2020, January). Prevalence of Maculopathy Associated with Long-Term Pentosan Polysulfate Therapy. Retrieved from https://www.aaojournal.org/article/S0161-6420(20)30040-3/abstract
  10. U.S. Food and Drug Administration. (2020, June). Elmiron Prescribing Information. Retrieved form https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020193s014lbl.pdf
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