Elmiron Lawsuit

Filing an Elmiron lawsuit is an option for patients who experienced maculopathy, a progressive eye disorder that can lead to permanent vision loss and blindness, following use of this medication for bladder pain.

Contact an Elmiron Lawyer Today

The defective drug attorneys at Bernstein Liebhard LLP are now offering free, no-obligation legal reviews to individuals who were diagnosed with maculopathy after taking Elmiron for interstitial cystitis. To learn more about filing an Elmiron lawsuit, please contact our office by filling out the form on this page or call direct at (888) 994-5118.

What is Elmiron?

Janssen Pharmaceuticals has marketed Elmiron (pentosan polysulfate sodium) to relieve bladder pain and discomfort associated with interstitial nephritis since 1996. This condition, which causes sufferers to experience bladder pressure and pelvic pain ranging from moderate to severe, affects an estimated 1 million people in the United States, the majority of whom are women.

It’s believed that Elmiron works by attaching itself to the bladder wall, creating a protective barrier from urine and other irritating substances.

While Elmiron’s patent expired in 2010, it remains the only approved treatment for interstitial nephritis and there are no generic equivalents. As a result, many patients continue to pay thousands in out-of-pocket costs and Janssen continues to reap millions in profits from sales of Elmiron.

Elmiron and Vision Loss

A growing body of evidence suggests exposure to Elmiron may damage the macula of the retina, the part of the eye associated with highly sensitive and accurate vision.

Between 1997 and 2019, for example, the U.S. Food & Drug Administration’s (FDA) Adverse Event Reporting System (FAERS) received 100 reports of eye disorders related to the use of Elmiron. Eight cases were considered serious and 22 mentioned various forms of maculopathy.

In 2018, doctors at the Emory Eye Center in Georgia reported that six Elmiron patients had developed unusual changes in their macula after roughly 15 years of treatment. There was nothing in the patients’ medical histories or diagnostic tests that could explain the pattern of abnormalities, prompting the doctors to point the finger at Elmiron.

In October 2019, ophthalmologists at Kaiser Permanente reported that detailed eye imaging exams of 91 Elmiron patients found clear evidence of drug toxicity in 22. The rate of toxicity rose with the amount of Elmiron consumed, from 11% of those taking 500 to 1,000 grams to 42% of those taking 1,500 grams or more.

The following month, a case study published in Ophthalmic Surgery, Lasers and Imaging Retina reported on a 69-year-old woman who had been diagnosed with maculopathy following treatment with Elmiron. Although she stopped taking the medication when she was 62, eye exams conducted when she was 67 and again when she as 69 showed the degeneration had continued to progress.

The Elmiron label does not include any mention of maculopathy. In fact, the only vision-related disorders noted are located in the Adverse Reactions section, which references nystagmus, conjunctivitis, optic neuritis, amblyopia, and retinal hemorrhage that occurred during Elmiron’s clinical trials. The labeling includes no relevant warnings and identifies no relevant adverse events observed in the post-marketing setting.

What is Maculopathy?

Maculopathy describes any pathological condition affecting the macula. Common forms include age-related macular degeneration cellophane maculopathy, and Malattia Leventinese.

The type of maculopathy most frequently reported among Elmiron patients is characterized as “pigmentary maculopathy of unknown etiology”. While exact presentation varies from patient to patient, symptoms may include any or all of the following:

  • Parafoveal pigmented deposits: Capillaries and small blood vessels surrounding the macula become abnormal, resulting in vision loss.
  • Vitelliform deposits: Round, yellowish lesions that form underneath the macula (also known as adult pattern macular dystrophy).
  • Retinal pigment epithelium atrophy: A common symptom of age-related macular degeneration.
  • Hyperpigmented, dark spots on the retina that can be observed during an eye examination.

Medical experts are now recommending that all Elmiron patients undergo ophthalmic examinations for early detection of pigmentary maculopathy, particularly those who’ve taken the medication for an extended period of time.

Learn if You Qualify to File an Elmiron Lawsuit

Anyone who developed maculopathy following Elmiron treatment deserves compensation for all of their injury-related damages, including:

  • Medical bills
  • Lost wages
  • Permanent disability
  • Pain and suffering
  • Loss of enjoyment
  • Emotional distress

If you’re interested in pursuing a claim, please contact our Elmiron lawyers at (888) 994-5118 for your free, no-obligation case review.

  1. FDA (1998) “Elmiron- 100mg” https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020193s009lbl.pdf
  2. Ophthalmology (2018) “Pigmentary Maculopathy Associated with Chronic Exposure to Pentosan Polysulfate Sodium” https://www.aaojournal.org/article/S0161-6420(17)33695-3/abstract
  3. Science Daily (2019) “More evidence linking common bladder medication to a vision-threatening eye condition” https://www.sciencedaily.com/releases/2019/10/191012141218.htm
  4. OSLIRetina (2019) “Progressive Maculopathy After Discontinuation of Pentosan Polysulfate Sodium” https://doi.org/10.3928/23258160-20191009-10
  5. Retinal Physician (2019) “Pentosan Polysulfate Maculopathy” https://www.retinalphysician.com/issues/2019/september-2019/pentosan-polysulfate-maculopathy
Last Modified: March 10, 2020

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