Elmiron & Vision Loss

Interstitial cystitis (IC) is a chronic bladder condition that most often affects women and can cause bladder pressure, bladder pain, and pelvic pain. This condition is part of a series of conditions commonly referred to as “painful bladder syndrome.” Elmiron, whose generic name is pentosan polysulfate sodium (PPS), is manufactured by Janssen Pharmaceuticals, a subsidiary of pharmaceutical giant Johnson & Johnson. Elmiron has been the only oral medication approved by the U.S. Food and Drug Administration (FDA) to treat interstitial cystitis.

Recently, women who have been taking Elmiron for bladder pain and discomfort secondary to interstitial cystitis reported an unexpected, serious side effect. The side effect was an eye condition known as retinal pigmentary maculopathy, which can result in permanent loss of vision. While most of the vision loss claims involved patients who had reported taking Elmiron for at least three years, there were also reported cases involving patients who had taken the medication for shorter times.

The warning on Elmiron’s packaging was updated in June 2020 to alert patients of the potential retina damage and vision loss that could result from taking Elmiron. The update to the warning label came after medical studies, including studies from Emory Eye Center in Atlanta and the American Academy of Ophthalmology, and suggested that Elmiron could cause a condition known as retinal pigmentary maculopathy and/or macular degeneration. Interestingly, the updated Elmiron label does not warn patients of potential permanent loss of vision. For the complete text of the FDA warning regarding Elmiron, please see: Drug Safety-related Labeling Changes (SrLC)

The above-referenced studies done at the Emory Eye Center in Atlanta and by the American Academy of Ophthalmology resulted in very similar findings in patients who had long-term use of Elmiron. Both studies found that patients who reported significant use of Elmiron had experienced side effects which included:

• Eye pain
• Blurred vision
• Difficulty reading
• Problems adjusting to dim lights
• Colors are less vivid
• Loss of vision

The defective drug and medical device attorneys at Suthers & Harper have experience handling cases for individuals who were injured and damaged by both prescription and over-the-counter medications. Our law firm has litigated cases against various pharmaceutical giants, including Johnson & Johnson, and have the requisite skill and resources to investigate and pursue potential claims involving dangerous drugs. For more information about the cases we have handled involving defective or recalled drugs and medical devices, please see our website.

If you or a loved one have suffered vision problems that you believe may have been caused by taking Elmiron, you may have a claim for damages against the drug’s manufacturer. Patients who took Elmiron for at least three years and developed any of the above-listed side effects or complications, including permanent vision loss, should contact the defective product attorneys at Suthers & Harper by using our contact email form or calling us toll free at 1-800-320-2384. There are strict time limits within which such claims must be filed, so please do not delay in contacting an experienced attorney to discuss a potential claim against the drug’s manufacturer.