Elmiron Litigation

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Elmiron Lawsuit Signed Cases

This medication treats pain and discomfort due to a bladder disorder, interstitial cystitis (IC), but a side effect may be severe vision problems. These issues can arise even after using the drug for a short time. If your practice includes medical product liability cases, Elmiron may be a good fit for your law firm.

Elmiron (pentosan polysulfate PPS) may work by creating a layer on the bladder wall and protecting it from harmful substances in the urine. The vision problems patients using it may suffer include:

  • Retinal maculopathy, macular degeneration, pattern dystrophy, or retinal disease
  • Two of the following problems: Difficulty reading, difficulty adapting to dim lighting, and blurred vision (often in the center of the person’s field of vision)
  • Dark spots in the center of vision
  • Straight lines appear curved or squiggly
  • Muted, less vivid colors

If the person is older than 50 and there is no other explanation for the issues, Elmiron may be to blame.

The retina is a layer of tissue lining the back of the inside of the eye near the optic nerve. It receives light that the lens has focused, converts it into neural signals, and sends these signals to the brain for visual recognition. The macula is at the center of the retina.

The link between Elmiron and eye injuries

The Interstitial Cystitis Network (ICN) warns those suffering the condition of the possible vision problems associated with the drug and lists medical studies documenting issues with the drug. The organization urges patients who are or who have used Elmiron to be screened by ophthalmologists if they are experiencing any unusual eye symptoms and to stop using the drug if eye disease is found.

In 2018, Dr. Neiraj Jain and his colleagues wrote a letter to the Journal of Urology’s editor stating they found retinal changes in six patients with long term Elmiron use. The changes suggested an injury to the retina and the underlying tissue. They found the cases unlike other retinal diseases.

Doctors Robert Moldwin and Curtis Nickel responded to the letter, stating, “…the implications are either frightening if our treatment is causing this condition or instructive if this condition is a previously unknown manifestation of IC/BPS (interstitial cystitis/bladder pain syndrome).” They also stated the Emory Eye Center identified more cases.

“Pigmentary Maculopathy Associated With Chronic Exposure to Pentosan Polysulfate Sodium” was published in the Journal of Ophthalmology in May 2018. It focused on six women with IC who suffered pigmentary maculopathy (a disorder of the macula). None had a family history of retinal disease and no other cause was found. The youngest patient was 37 years old. One was diagnosed when she was 23 and started having vision problems seven years later.

The authors suggested the retinal cells may be accumulating Elmiron or a toxic metabolite (a small molecule of the drug) over time. They pointed to an early Elmiron study where vision changes were reported in some of 2499 patients who took the drug for up to four years. Though they stated it was too early to decide there was a definite connection between Elmiron and vision problems, they didn’t appear to be inherited or acquired some other way.

At the American Urology Association Annual Meeting in May 2019, a group from the Emory Eye Center presented a study of ten IC patients who used Elmiron and suffered macular disease. They ranged in age from 38 to 68. The most common symptoms were difficulty reading and adapting to dim lighting. Their clinic had seen 156 patients with IC/BPS who hadn’t used Elmiron. None of them showed pigmentary maculopathy.

A study by researchers at Kaiser Permanente released in October 2019 covered 140 of their patients who had taken Elmiron for a minimum of 5 years, 91 of whom agreed to an eye examination. Twenty- two, or 24%, showed eye injury which worsened with the amount of Elmiron taken.

Researchers at the Emory Eye Center in November 2019 shared data from a national study of patients. After five years of Elmiron use there was no significant association of its use and eye injury, but at seven years users had significantly increased odds of having the vision problems associated with the drug’s use.

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