Elmiron Lawsuit for Pigmentary Maculopathy

By Levin Simes
April 16, 2020

Elmiron Lawsuit

Elmiron patients have experienced permanent eye damage after long term use of the medication.  Patients were originally prescribed Elmiron for interstitial cystitis, urinary infections, or off-label reasons, and users have now reported worsening eye injuries.

Levin Simes represents those injured by hidden side effects of medication such as Elmiron.  You can contact an Elmiron lawyer by starting a chat, emailing us at info@levinsimes.com, or calling us at (415) 426-3000.

Elmiron Maculopathy

Elmiron is the brand name of pentosan polysulfate sodium (PPS). The approved dosage is 100 mg, three times a day, to help prevent painful irritation from urination.  Despite its approval by the FDA, a recent placebo-controlled study with randomized patients – which is the hallmark of top study design – failed to show Elmiron was effective.

Despite a potential lack of efficacy, Elmiron has been a big seller for its manufacturer Janssen due to a lack of competition.  Sales are estimated at more than $150 million per year, including in 2020, despite loss of patent protection.

Elmiron has been linked with eye damage including pigmentary maculopathy.  The FDA Adverse Events Reporting System (FAERS) shows dozens of reports of injuries including:

  • Maculopathy
  • Eye Pain
  • Eye Disorder
  • Macular Degeneration
  • Blindness
  • Blindness Unilateral
  • Retinal Disorder
  • Age-Related Macular Degeneration
  • Night Blindness
Reports to FDA of Eye Injury from Elmiron

Do Studies Show Elmiron Causes Retinal Maculopathy?

Multiple case study reports, studies, and research point to a growing body of scientific evidence linking Elmiron to eye injury side effects.

In 2018, William Pearce, Rui Chen and Nieraj Jain published in the Journal of Ophthalmology an article of retrospective case studies linking Elmiron to Pigmentary Maculopathy (1). They reviewed the cases of six patients with eye injuries of avoidable maculopathy associated with chronic use of Elmiron.

Additionally, an article in the Canadian Journal of Ophthalmology (2) describes a cross-sectional study designed to understand the prevalence of PPS-associated maculopathy.  It concluded:

Our findings corroborate recent reports that prolonged consumption of [Elmiron – Pentosan Polysulfate Sodium] can lead to vision-altering changes in the macula with relatively unique findings with multimodal retinal imaging.

An investigation published in the Journal of the American Medical Association (JAMA) Ophthalmology studied another 35 Elmiron patients, finding five of the patients with the signature rare eye injury pigmentary maculopathy (3).  The authors conclude:

These findings suggest that PPS–associated maculopathy is a vision-threatening condition that can manifest in the setting of long-term exposure to [Elmiron].

Another study of US patients discovered that patients who used the drug for seven years showed elevated rates of macular disease (4).

In October 2019, yet another study was published linking Elmiron to retinal damage.  This study found that 25% of patients with long term or significant exposure to the drug had developed eye damage. (5)

  1. Pigmentary Maculopathy Associated with Chronic Exposure to Pentosan Polysulfate Sodium (Elmiron)
  2. Pentosan-associated Maculopathy: Prevalence, Screening Guidelines, and Spectrum of Findings Based on Prospective Multimodal Analysis.
  3. Phenotypic Spectrum of Pentosan Polysulfate Sodium–Associated Maculopathy (Elmiron Associated)
  4. Association of macular disease with long-term use of pentosan polysulfate sodium: findings from a US cohort
  5. More evidence linking common bladder medication to a vision-threatening eye condition

Retinal Damage from Pigmentary Maculopathy

Pigmentary Maculopathy is a disorder of the eye involving the macular, or retina center, where light is taken in by the eye.  Maculopathy is simply damage to this portion of the retina and can occur for age-related reasons in age-related macular degeneration.

Study after study has shown Elmiron patients are developing a unique maculopathy disease involving the retinal pigment epithelium. In the diagram below, this is the area between the yellow layer representing the retina and the purple inner portion of the eye.  This epithelial layer is developing deposits resulting in loss of vision and other eye injury in patients taking Elmiron.   In severe cases, these growing deposits intrude into the vessels of the eye.

Elmiron Lawsuit - Eye Damage - Image of Eye

Patients as young as 30 years old have shown this unique degenerative eye disease after years of taking Elmiron.

Elmiron Blindness

Maculopathy can result in multiple increasing forms of vision loss.  Night blindness, inability to read in low light, dimming of vision, loss of near vision, full vision loss or blindness and metamorphosia (distorted vision) have all been reported.

Types of Elmiron Eye Damage:

  • Blurred vision
  • Blindness
  • Blindness (bilateral)
  • Blindness (night)
  • Dark spots in vision
  • Difficulty reading
  • Dim vision
  • Distorted vision
  • Eye pain
  • Macular degeneration
  • Metamorphopsia
  • Pigmentary Maculopathy
  • Retinal Maculopathy

If you are suffering eye damage or vision loss after using Elmiron, please reach out to the lawyers of Levin Simes for more information.

Elmiron Side Effects

Elmiron was approved for the relief of bladder pain or discomfort associated with interstitial cystitis.

What Are the Side Effects of Elmiron?

The listed side effects of Elmiron include: alopecia, diarrhea, nausea, headache, rash, dyspepsia, abdominal pain, liver function abnormalities and dizziness.

Was Eye Injury Warned in the Elmiron Label?

No.  Janssen did not warn of permanent loss of vision or eye damage from their product.  The label does note a study patient suffered from retinal hemorrhage, with no indication to the consumer about potential risks of retinal injury to patients.

Studies show 25% of patients who use Elmiron long term develop various forms of maculopathy.

You can review the label for yourself here: Elmiron label.

Elmiron Lawyer

Levin Simes is a nationally recognized law firm with decades of experience fighting pharmaceutical companies.  We’ve recovered billions for our thousands of clients, held national leadership positions for pharmaceutical mass torts similar to 2020 Elmiron lawsuits, and continue to fight on behalf of those injured by hidden drug side effects.

Contact an Elmiron lawyer today for a free private legal consultation.  Start a chat here, call us at (415) 426-3000, or email us at info@levinsimes.com.

Elmiron Lawsuit - Elmiron Lawyer - Eye Injury

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