Recent studies have found that Elmiron (pentosan polysulfate sodium), a medication developed to treat bladder pain or discomfort associated with Interstitial Cystitis (IC), has been linked to serious eye problems. Since its approval in 1996, the side effects associated with Elmiron have not included any warnings of possible loss of vision or other eye problems involving the degeneration of the retina. Further investigation has found there to be a link between a specific pigmentary maculopathy that is unique to patients who have taken Elmiron over sustained periods of time. These findings have also shown a direct correlation between the severity of the degeneration and the amount of Elmiron consumed by patients.  

What is Elmiron?

Elmiron is a prescribed oral medication developed to treat bladder pain or discomfort for those suffering from IC. IC, a chronic condition that causes pressure on the bladder, bladder pain, and pelvic pain, can range in severity from mild discomfort to severe discomfort. Symptoms of IC include:

• Pressure, discomfort or tenderness in the bladder, abdomen, or pelvic area
• Urinary urgency throughout the day
• Waking up or trouble sleeping because of frequently needing to urinate
• Burning sensation of pain (pelvic region)
• Pain that increases as bladder fills
• Pelvic floor muscle pain
• Pain during or after sexual intercourse

Elmiron promises to help patients with IC by forming a thin protective layer on the wall of the bladder to defend it from irritants passing through the urinary tract. Unlike other pain relievers (Tylenol, Ibuprofen, etc.), Elmiron does not stop inflammation but attempts to protect the lining of the bladder as a preventative measure. In working to remedy the root of the issue (the irritation in the bladder) as opposed to the result (inflammation and pain), Elmiron is designed as a long-term solution that builds up a defense against IC. Elmiron does not cure IC but only attempts to help prevent the pressure and pain created by IC.  

In addition to helping build a lining to protect the bladder, Elmiron is a weak anticoagulant “blood thinner” that increases patients’ risk of bruising and bleeding. Since the medication was approved by the FDA in 1996, it remains the only drug approved to treat bladder pain and discomfort associated with IC. With no competition, the drug has been prescribed to hundreds of thousands of people who suffer from IC.[1]

Elmiron linked to severe degeneration of the eye

Despite being the only option for patients, it has not been proven to be overly effective in helping patients with IC. A 2015 study, published by the Journal of Urology, found that the drug was only marginally more effective in treating complications related to IC than when compared to results from a placebo drug. In this double-blind study, 40.7% of the patients in the placebo group achieved a significant reduction in pain, only slightly below the 42.6% of patients that achieved similar results after taking 300mg of Elmiron daily.[2] The negligible difference between the two groups of participants is concerning, considering the recent findings that long-term use of Elmiron can lead to “injury to the retina and the underlying retinal pigment epithelium.”[3] The conclusion of the study found that just over 48% of the patients who used Elmiron over a sustained period reported symptoms of pigmentary maculopathy, a degeneration of the macula which is located at the center of the retina.[4]  

Following these findings in 2018, additional studies were launched that reinforced these initial conclusions. One study stated that “this characteristic maculopathy has, to date, been exclusively diagnosed in patients reporting prior [Elmiron] exposure.”[5] In addition, a study found that 22 of the 91 patients examined showed clear signs of retinal damage that directly correlated to the amount Elmiron each patient had consumed over several years. Those who had taken the drug for longer periods demonstrated greater damage to the macula.  

IC Network petition FDA to change Elmiron’s warning label

After learning the results of the study, the IC Network, a organization that gives support to those living with IC, petitioned the FDA to have the warning label of Elmiron updated to include the possibility of vision loss and maculopathy. In addition, the petition asked that FDA issue an alert to all patients who are currently taken or who have previously taken Elmiron, warning them of the potential for changes in vision and eye function.  

As a result of the studies, the petition put together by the IC Network, and the FDA, the Elmiron label was updated to include a warning about the possibility of “retinal pigmentary changes.” Including on the label that a “baseline retinal examination is suggested for all patients within six months of initiating treatment and periodically while continuing treatment.”[6] These changes are extremely important as the litigation against the manufacturers of Elmiron, Jessen Pharmaceutical and Teva Branded Pharmaceuticals, continues to grow. More patients are joining the growing litigation every week as they realize their vision changes are due to their sustained use of Elmiron.  

Have you suffered any side effects from taking Elmiron?

The lawsuits seek to hold these companies responsible for failing to warn their consumers of the risks associated with taking Elmiron. These symptoms include:

• Difficulty reading
• Prolonged dark adaptation  
• Partial loss of vision
• Total loss of vision

If you or someone you know has been prescribed Elmiron and has experienced any of these symptoms or have been diagnosed with degeneration of the macula, you may be entitled to significant compensation from the manufacturers of Elmiron without ever going to court. To find out if you or a loved one is eligible, fill out our free case review and we’ll help you determine if you have a claim, navigate the process, and maximize your potential compensation. If you do not receive a recovery through a lawsuit or settlement, you don’t owe us anything.  

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References

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1. ‍https://www.drugwatch.com/elmiron/ ‍
2. https://www.auajournals.org/article/S0022-5347(14)04431-0/fulltext
3. Ibid. ‍
4. https://www.reviewofophthalmology.com/article/clinical-pearls-for-a-new-condition ‍
5. Ibid. ‍
6. https://www.ic-network.com/elmiron-label-has-been-changed-to-include-a-warning-about-eye-disease/

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