Are you experiencing eye problems or vision loss after being prescribed Elmiron for a bladder condition? The Collins Law Firm is now accepting Elmiron eye injury claims for people who have suffered vision loss and pain after using Elmiron to treat interstitial cystitis. However, the time limit for filing an Elmiron lawsuit may be running out, so do not delay.
Call us at 630-527-1595 or fill out our contact form for a free evaluation of your Elmiron eye injury claim as soon as possible. There is no risk; you owe us nothing unless we recover money for you, and you may be entitled to significant compensation for your injuries.
Don’t suffer in silence. Let our Naperville Elmiron attorneys help you get justice.
People are filing lawsuits against Janssen, the company that manufactures Elmiron, because the drug has been linked to pigmentary maculopathy, an eye condition that can cause irreversible vision loss and even blindness. Elmiron has been prescribed to treat a bladder condition, interstitial cystitis (IC), that affects up to a million people, mainly women, in the US. The condition causes pain and pressure in the bladder area, and Elmiron is the only FDA-approved medication to reduce these symptoms in people with IC. Unfortunately, studies have linked long-term Elmiron use to a specific type of eye damage called pigmentary maculopathy. Up to 25% of long-term Elmiron users may have some form of this eye damage, which is not to be confused with age-related macular degeneration. The lawsuits allege that Janssen failed to warn patients that Elmiron could cause this serious and permanent eye damage.
Multiple studies have linked Elmiron to pigmentary maculopathy, a specific form of retinal maculopathy. In 2016, ophthalmologists at Emory University began to see a new eye disease “retinal maculopathy” in patients who had one thing in common: the use of Elmiron. Concerned, they began digging through old records of the Elmiron approval process and found numerous adverse reports of eye damage dating back to the 1990s. After that, several studies of Elmiron discovered similar patterns of retinal damage, including one study that found nearly 25% of Elmiron patients had eye damage and another that concluded that 20% of Elmiron patients faced a significant risk of macular toxicity. One study even found that retinal maculopathy continued to worsen even after the patients discontinued using Elmiron. The following include some of the studies linking Elmiron to pigmentary maculopathy and vision loss:
A 2018 study led by Nieraj Jain, M.D. at the Emory Eye Center found a novel type of pigmentary maculopathy in six patients who were taking Elmiron for interstitial cystitis. Pigmentary Maculopathy Associated with Chronic Exposure to Pentosan Polysulfate Sodium, William Pearce, Rui Chen, Nieraj Jain, (November 2018)
A second Emory University Study (2019) concluded that avoidable retinal degeneration was linked to chronic Elmiron usage. Those who did not take the drug showed no sign of pigmentary maculopathy. Chronic Exposure To Pentosan Polysulfate Sodium Is Associated With Retinal Pigmentary Changes And Vision Loss, Jenelle Foote, Adam Hanif, And Nieraj Jain, (April, 2019).
A Kaiser Permanente study (2019) found that approximately 25% of patients taking Elmiron had signs of retinal damage and those with significant exposure to the drug had more damage. Prevalence of Maculopathy Associated with Long-Term Pentosan Polysulfate Therapy Robin A. Vora, M.D , Amar P. Patel, M.D., and Ronald Melles M.D.
Another Jain study (November 2019) discovered that patients who took Elmiron for seven years had higher odds of macular disease than those who took Elmiron for five years. Association of macular disease with long-term use of pentosan polysulfate sodium: findings from a US cohort, Nieraj Jain et al, (November 2019)
A study by Huckfeldt and Vavvas (November 2019) found that a patient continued to get worsening pigmentary maculopathy even six years after stopping Elmiron. Progressive Maculopathy After Discontinuation of Pentosan Polysulfate Sodium, Rachel M Huckfeldt, et al, (October 2019)
The findings in this study suggested that long-term exposure to pentosan polysulfate sodium (Elmiron) was related to is a vision-threatening form of maculopathy. Phenotypic Spectrum of PeStudy concluded that Pentosan Polysulfate Sodium-Associated Maculopathy: A Multicenter Study, Adam Hanif et al, (September 2019)
Moreover, the longer a person uses Elmiron, the more eye damage it may cause. Retinal maculopathy is a very serious, progressive disease, that can cause irreversible vision loss. However, Elmiron contained no warning about the risks of eye damage until 2020, two years after the publication of the first studies. Instead, Janssen continued to receive billions of dollars in revenue from this drug, while exposing thousands of patients to the risk of losing their sight.
Pigmentary Maculopathy is an eye condition that affects the macula of the eye, an area at the rear of the retina which focuses central vision, recognizes details, colors, and faces, and is pivotal for reading. The disorder causes dark spots or hyperpigmentation on the retina that can be observed during an eye exam. Pigmentary maculopathy typically affects both eyes and is a progressive condition which can cause irreversible vision loss. Symptoms of pigmentary maculopathy may include:
Elmiron is the brand name for pentosan polysulfate sodium, a drug manufactured by Janssen Pharmaceuticals, a division of Johnson & Johnson. In 1985 Elmiron was approved under the “orphan drug” status to treat what was then considered a rare disorder, interstitial cystitis, or painful bladder syndrome. After that, the FDA issued non-approval letters for Elmiron in 1993 and 1994 due to very weak evidence of efficacy. Nevertheless, it was finally approved by the FDA in 1996--based on evidence from a compassionate use database that it worked for a small subset of patients--and has been on the market for 25 years. Since then several studies have concluded that Elmiron provides no benefit for the majority of patients, but doctors continue to prescribe this medication. Patients who are prescribed Elmiron typically take 100 mg doses three times a day, and it can take 3-4 weeks to 6-9 months to see an improvement in bladder symptoms. Many patients have been on Elmiron for years or even decades. Because it is the only FDA-approved medication to treat interstitial cystitis, it has been prescribed to hundreds of thousands of patients over the years.
Interstitial cystitis, or painful bladder syndrome as it is also called, is a chronic bladder condition defined by pain and pressure in the bladder area. People who suffer from IC complain about chronic urinary tract symptoms that can last from 6 weeks to two years. These symptoms mimic traditional urinary tract infections despite no infection being present. Symptoms include:
Researchers are not sure exactly what causes interstitial cystitis but suspect weak pelvic muscles, ulcers, trauma to the bladder, and a history of bladder infections may contribute to the problem. Some people who experience symptoms also suffer from autoimmune diseases or irritable bowel syndrome (IBS). Stress can exacerbate the symptoms, as can certain foods and beverages.
Doctors still do not know a lot about how to treat interstitial cystitis because the problem is complex and may be caused by multiple factors. Doctors often advise IC patients to avoid coffee, tea, alcohol, soda, citrus fruits, spicy foods, and artificial sweeteners that can cause IC flare-ups. Reducing stress, not smoking, exercising, and eating more fruits and vegetables may also help. Unfortunately, no simple treatment eliminates IC and nothing works for everyone. Beyond these lifestyle changes, doctors often turn to several other treatments for IC, including:
No. Despite the evidence that Elmiron is linked to pigmentary maculopathy, the drug has not been recalled. Elmiron remains on the market amid increasing lawsuits by patients who have been harmed by the drug.
If you have been taking Elmiron, it is important that you talk to your physician to determine if you should stop taking the drug. If you are experiencing any symptoms or signs of vision problems or vision loss, you should see your ophthalmologist for a comprehensive examination as soon as possible, and let him or her know you have been on Elmiron. Ask to see a retinologist to get tested for pigmentary maculopathy.
You may have an Elmiron lawsuit if you have been taking the drug for a while and have developed vision loss or have been diagnosed with pigmentary or retinal maculopathy. In this case, you may be entitled to compensation and should seek legal help as soon as possible. Litigation is currently in the early stages and people are filing claims now. Because of the potential statute of limitations, you should act quickly if you think you have a claim.
If you or a loved one have been diagnosed with pigmentary maculopathy by your eye doctor, and you believe it is related to your long-term use of Elmiron, you may have a claim against the manufacturers. We are investigating cases of vision loss and serious eye damage in adults who have been prescribed Elmiron by their doctor, so contact us for help. Our experienced lawyers will confirm your diagnosis and make sure you have a good lawyer fighting for you. Call us at (630) 527-595 or fill out our contact form herefor a FREE evaluation of your Elmiron claim. There is no obligation and no cost unless we win your case. Let us help you get the compensation you deserve.
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