Elmiron - Consumer Justice Foundation

Elmiron

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Patients taking the bladder drug Elmiron (pentosan polysulfate) may be at risk for a degenerative eye disease known as retinal maculopathy or pigmentary maculopathy, which may continue to cause permanent vision problems even after the drug treatment is discontinued.  

People suffering from chronic interstitial cystitis or painful bladder syndrome only have one option when it comes to treating their condition with an FDA-approved oral medication: pentosan polysulfate, sold under the brand name Elmiron. Unfortunately, long-term use of the popular bladder drug has been linked to reports of a degenerative eye disease known as retinal maculopathy or pigmentary maculopathy. People with this condition may experience debilitating vision problems like irreversible vision loss, blurred vision, dark spots in their vision and possibly even blindness. If you were recently diagnosed with macular degeneration or another retinal disease, or if you are noticing vision problems like difficulty reading or a loss of vision detail, and you are a long-time Elmiron user, you could be experiencing retinal maculopathy. Contact our consumer advocates at Consumer Justice Foundation today to find out if you may be eligible to file an Elmiron vision loss lawsuit against the drug manufacturer.

Elmiron Alternatives for Painful Bladder Syndrome

Taking into consideration the potential for long-term Elmiron use to cause permanent vision loss, patients diagnosed with interstitial cystitis may be looking for another way to treat their condition. Unfortunately, there are no other medications that have been approved to treat interstitial cystitis specifically. However, there may be other ways you can manage the symptoms of the bladder condition without taking Elmiron and risking your vision. The following are some possible Elmiron alternatives that may help with interstitial cystitis or painful bladder syndrome:

  • Physical therapy to relieve pelvic pain associated with muscle tenderness or restrictive connective tissue in the pelvic floor
  • Nonsteroidal anti-inflammatory drugs like ibuprofen (Advil, Motrin IB) or naproxen sodium (Aleve) to relieve pain
  • Antihistamines like loratadine (Claritin) to reduce urinary urgency and frequency
  • Transcutaneous electrical nerve stimulation (TENS) to relieve pelvic pain and reduce urinary frequency
  • Sacral nerve stimulation to reduce urinary urgency
  • Cystoscopy with bladder distention

Elmiron, Vision Loss and Regulatory Action

October 2019 – Health Canada announces Elmiron safety label updates that include the potential risk for pigmentary maculopathy with chronic use of Elmiron.

June 2020 – Janssen updates the Elmiron drug label to include a risk of “Retinal Pigmentary Changes,” warning that “Pigmentary changes in the retina, reported in the literature as pigmentary maculopathy, have been identified with long-term use of Elmiron. Although most of these cases occurred after 3 years of use or longer, cases have been seen with a shorter duration of use.”

Studies Linking Elmiron to Eye Damage

May 2018 – A study published in the online version of the medical journal Ophthalmology describes a “novel and possibly avoidable maculopathy associated with chronic exposure to PPS.”

November 2018 – Researchers from the Emory University School of Medicine, Department of Ophthalmology write a letter to the editor of The Journal of Urology, highlighting new information about vision problems and retinal changes associated with long-term exposure to Elmiron.

May 2019 – Researchers assess ten patients with retinal degradation who had undergone treatment with Elmiron for IC and describe a “unique form of pigmentary maculopathy” not found among 156 other patients with interstitial cystitis who did not take Elmiron. The findings of the study were presented at the Annual Meeting of the American Urological Association in Chicago.

September 2019 – The journal JAMA Ophthalmology publishes research highlighting 35 patients who reported long-term exposure to pentosan polysulfate sodium (Elmiron). The researchers conclude that “pentosan polysulfate sodium-associated maculopathy is a vision-threatening condition that can manifest in the setting of long-term exposure to the drug.”

October 2019 – Research presented at the 2019 Annual Meeting of the American Academy of Ophthalmology indicates that approximately one-quarter of patients with significant exposure to Elmiron show definite signs of retinal damage.

November 2019 – A case report published in the journal Ophthalmic Surgery, Lasers and Imaging Retina describes a 62-year-old woman who took Elmiron for 18 years and eventually stopped taking the drug after developing problems with her vision. Unfortunately, even after discontinuing treatment, the patient continued to experience worsening vision problems over the next six years.

December 2019 – Researchers from Kaiser Permanente Northern California publish a case report describing a 41-year-old “patient with a past diagnosis of Stargardt disease that was later determined to be pentosan polysulfate (PPS) maculopathy.”

January 2020 – The same researchers from the October 2019 study publish a follow-up study of 117 patients with IC who took Elmiron and found 27 patients who showed definite signs of maculopathy. The researchers write, “We believe that our findings add strong support to the growing body of evidence that links long-term PPS use to the potential development of a toxic maculopathy.”

Why We Think the Manufacturer of Elmiron Should Be Held Liable

Many patients taking Elmiron for interstitial cystitis have experienced serious eye damage and suffered debilitating problems with their vision that could have been avoided had they been warned about the potential risk of maculopathy from pentosan polysulfate exposure. Given the fact that interstitial cystitis affects more than one million people in the U.S. and Elmiron is the only known IC treatment on the market, it is estimated that hundreds of thousands of people have been exposed to the medication. Unfortunately, because there have been no warnings about the potential for Elmiron to cause vision loss, individuals suffering from alleged Elmiron-associated maculopathy may continue taking Elmiron, unaware that the medication may be what is causing their vision problems. Elmiron maculopathy lawsuits brought against Janssen Pharmaceutical accuse the company of:

  • Failing to properly research the long-term effect of Elmiron use on patients’ vision
  • Knowing that long-term Elmiron use can cause irreversible vision problems
  • Failing to adequately warn patients and the medical community about this potential risk
  • Failing to follow up and investigate reports of retinal maculopathy among Elmiron users
  • Withholding crucial Elmiron warnings and prescribing information from patients and healthcare providers
  • Failing to issue an Elmiron recall as soon as it became evident that long-term users may face a risk of irreversible vision loss or blindness
  • Continuing to market and sell Elmiron as safe and effective, despite the potential risk of retinal maculopathy

What should you do? If you have suffered retinal maculopathy or pigmentary maculopathy allegedly caused by Elmiron, you should contact a lawyer as soon as possible to discuss filing an Elmiron lawsuit.

Financial compensation may be available to Elmiron patients suffering from retinal maculopathy through an Elmiron injury lawsuit. It is common for individuals suffering from Elmiron-associated maculopathy to be misdiagnosed with macular degeneration, pattern dystrophy, Stargardt disease or macular dystrophy, resulting in continued Elmiron use. Unfortunately, evidence suggests that maculopathy associated with chronic Elmiron exposure may continue to worsen even after the drug treatment is discontinued. Attorneys across the country are currently investigating claims on behalf of patients with IC who have experienced vision loss or blindness allegedly caused by Elmiron, and plaintiffs in the Elmiron litigation claim that they could have avoided these life-changing vision problems if Janssen had provided adequate warnings about the potential risk of eye damage from Elmiron. Had the company notified patients and healthcare professionals about the importance of monitoring for vision-related symptoms during Elmiron treatment, the problems may have been detected with a simple eye exam.

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