Does Elmiron medicine cause eye diseases?

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Researcher: Ariana Arce​

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Journalist: Aaron Vivanco

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Editor: Daniela Polo

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Does Elmiron medicine cause eye diseases?

In November 2018, the Emory Eye Center in Atlanta published a study that discovered a novel and potentially avoidable maculopathy associated with chronic exposure to Elmiron.

Two recent medical studies have also linked previous Elmiron usage to pigmentary maculopathy and vision loss.

What is Elmiron medicine used for?

Elmiron (pentosan polysulfate sodium, PPS) is the only FDA-approved oral medication available for treating bladder pain or discomfort associated with interstitial cystitis (IC).

Elmiron Lawsuit. Has Elmiron been recalled?

No. Elmiron is still on the market despite a slew of lawsuits filed. Just a few patients suffered permanent vision loss and other side effects after taking the drug as prescribed.

What is the most important information I should know about Elmiron medicine? Elmiron has been linked to several serious side effects, including the following:

Changes in the retina (pigmentary maculopathy). The consumption of Elmiron may cause pigment changes in the retina of the eye, which may persist even after the medication is stopped. If you experience any vision changes, including any of the following symptoms, tell your healthcare provider, including your eye doctor, right away:
– Difficulty reading
– Prolonged adjustment of eye vision to low or reduced light.

Increased bleeding. Elmiron may cause increased bleeding. If you experience any of the following symptoms, tell your healthcare provider right away.
– Bruising easily
– Nosebleeds
– Bleeding gums
– Blood in stool

Your risk of bleeding may increase if you take Elmiron with other medicines such as:
– Warfarin sodium
– High doses of aspirin
– Heparin
– Anti-inflammatory medicines such as ibuprofen

Does Elmiron cause pigmentary maculopathy?

Elmiron may cause pigmentary maculopathy, a severe eye disease that affects one out of every 4 patients who take the bladder drug. The following six studies show evidence that about 25% of people who take the Elmiron drug for 6 months or longer develop the eye disease:

  1. In an Emory Eye Center study (May 2018), 6 Elmiron patients developed pigmentary maculopathy.
  2. According to a second Emory Eye Center study on 10 patients (April 2019), patients with IC, who did not take Elmiron, did not develop pigmentary maculopathy.
  3. According to a Kaiser Permanente study (October 2019), 22 of 91 Elmiron patients exhibited signs of toxicity. Patients who consumed more of the drug exhibited higher toxicity.
  4. According to a study by Jain (November 2019), patients who took Elmiron for 7 years had a higher risk of macular disease than those who took it for 5 years.
  5. According to a study by Huckfeldt and Vavvas (November 2019), a patient’s pigmentary maculopathy worsened even 6 years after stopping the use of Elmiron.
  6. According to Vora, Patel, and Melles (January 2020), 27 of 117 Elmiron users developed pigmentary maculopathy. Patients who consumed more than 1,500 g of the drug were at a higher risk.

Other recent medical studies

The article, “Pentosan Polysulfate and Vision:

Findings from an International Survey of Exposed Individuals,” was published in the Retina Medical Journal in December 2020.
Purpose: To investigate patient-reported visual function among individuals who were taking Elmiron for IC.
Results: Compared to unexposed respondents, respondents in the highest PPS exposure tertile were more likely to experience difficulty reading small prints and to be diagnosed with macular degeneration and/or pigmentary maculopathy.

The medical journal Clinical Ophthalmology investigated the prevalence of retinal pathology in patients with a history of exposure to Elmiron in February 2021.

The study cohort comprised a total of 131 patients, and 5 patients were suspected of having Elmiron maculopathy, while 5 other patients had macular pigmentary changes, and the patients were accordingly separated into a suspect group.

The study team members reviewed patient charts for fundus findings captured in the examination and ophthalmologic imaging, particularly multimodal imaging, including fundus photography, fundus autofluorescence, and ocular coherence tomography images.