Elmiron Lawyers Reviewing Cases for Vision Loss and Maculopathy
Elmiron (pentosan polysulfate sodium) was introduced by Janssen Pharmaceuticals in 1996, as a treatment interstitial cytisis or bladder pain syndrome, which impacts more than one million people throughout the United States.
While it was sold as a safe and effective drug for bladder and pelvic pain, growing research suggests that there is a link between side effects of Elmiron and macular degeneration, or other eye disease that results in irreversible retina damage, vision loss and blindness.
- Pigmentary Maculopathy
- Macular Degeneration
- Macular Retinopathy
- Retinal Deterioration
- Pattern Dystrophy
- Other Atypical Maculopathy
If earlier warnings and information had been provided about the potential risk of Elmiron eye damage, many individuals may have avoided these serious and life-changing vision problems, which may continue to worsen for years after last use of the interstitial cytisis drug.
Saiontz & Kirk, P.A. is reviewing potential claims for individuals throughout the United States, and all cases are handled on contingency fee basis. This means there are no out-of-pocket costs to hire our Elmiron vision loss lawyers and we only receive an attorney fee or expenses if a recovery is obtained.
Request a free consultation and case review on line or call 1-800-522-0102 to get started.
Elmiron Side Effects
Vision Problems from Elmiron may include symptoms:
- Blurry Vision
- Difficulty Reading
- Night Blindness (problems adjusting to dim light)
- Metamorphopsia (distorted vision with “wavy” or “rounded” look)
- Blind or Vision Loss
Elmiron (pentosan polysulfate sodium or PPS) is a prescription medication for individuals suffering from “interstitial cytisis”, which is involves severe bladder pressure, bladder pain and sometimes pelvic pain. It is part of a spectrum of diseases known as “painful bladder syndrome” and is most common among women.
Interstitial cytisis is often mistaken for a urinary tract infection (UTI), but is a chronic condition that has no known cure. As a result, most Elmiron users remain on the medication for years, if not decades.
The active pharmaceutical ingredient in Elmiron, pentosan polysulfate sodium or PPS, is a heparin-like compound that has anticoagulant and fibrinolytic effects. The exact mechanism of action for Elmiron treating interstitial cytisis is not known, even to the drug makers.
While the medication has been marketed as safe and effective, without adequate warnings that Elmiron may cause eye problems, users throughout the United States have been diagnosed with atypical retinal maculopathy and other eye disease that appears to be linked to long-term exposure.
Although there were more than a dozen published reports and papers involving vision problems or maculopathy from Elmiron side effects, the drug makers did not provide any information for users and doctors in the United States until June 2020, after thousands of long-term users had already been left with irreversible vision loss and retina damage.
Allegations Raised in Elmiron Class Action Lawsuits
The attorneys at Saiontz & Kirk are reviewing individual Elmiron injury lawsuits and class action claims over the vision loss and macular degeneration linked to side effects of the drug. According to allegations that will be raised in the litigation, the drug manufacturer has:
- Failed to properly research the Elmiron retina side effects on the before introducing the drug;
- Failed to promptly follow up and investigate reports of macular degeneration, pigmentary maculopathy and other retina damage among Elmiron users;
- Withheld critical Elmiron warnings and information from consumers and the medical community;
- Knew or should have known that monitoring for signs of Elmiron vision changes with regular examinations may helped avoid serious eye problems for many users;
- Failed to promptly issue an Elmiron recall or updated safety warnings as it became clear that long-term users may face a risk of vision loss, blindness and other eye problems;
Failure to Warn About Toxic Effects of Elmiron Worsened Retina Damage
Many patients who took Elmiron and experienced eye problems may have suffered needlessly for years.
The drug-maker’s failure to warn caused lack of awareness among opthalmologists and the medical community about Elmiron-induced retinal damage.
Users who experienced symptoms of Elmiron vision loss were often misdiagnosed with other eye diseases by their doctor, such as
- age-related macular degeneration (AMD)
- pattern dystrophy
- Stargardt disease
- other genetic retina deterioration
As a result, users continued to take the drug, suffering further toxic side effects of Elmiron on their vision.
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Timeline of Elmiron Case Reports and Studies
A retrospective case series was published in the medical journal Opthalmology, describing six Elmiron vision loss cases involving atypical maculpathy associated with long-term use.
Users were evaluated between May 2015 and October 2017, with ages ranging from 37 to 62 years old, and the length of Elmiron exposure ranging between 12 and 20 years. Primary symptoms included difficulty reading and prolonged dark adaption, with examinations revealing retinal pigmentary maculopathy.
Letter to the editor was published in The Journal of Urology, responding to a report published in the July 2018.
Researchers with the Emory University School of Medicine, Department of Opthalmology wrote to alert readers to concerning new observations involving vision threatening retinal changes associated with Elmiron long-term exposure. Authors recommended any patient with Elmiron vision symptoms undergo comprehensive ophthalmic exams.
Findings were presented at the Annual Meeting of the American Urological Association in Chicago from a study involving 10 patients with vision threatening retinal degradation who had been treated for interstitial cytisis with Elmiron.
Researchers described a “unique form of pigmentary maculopathy”, and indicated that similar problems were not seen among 156 other patients treated for the same bladder condition who were not using Elmiron.
In a study published by the medical journal JAMA Ophthalmology, Canadian researchers described a condition described as “pentosan polysulfate sodium (PPS)-associated maculopathy” or Elmiron maculopathy.
Researchers reviewed medical records of 35 long-term Elmiron users who exhibited characteristics of maculopathy, including women between the ages of 37 and 79 years old, who had received the drug between 3 years and 22 years. Leading symptoms of Elmiron vision problems included metamorphopsia, blurred vision and prolonged adjustment to dark light.
Health Canada announced an Eliron warning update that added information about the risk of pigmentary maculopathy reported among long-term users.
Updated warnings recommended that long-term Elmiron users have regular ophthalmic eye examinations for early detection of the retinal problems, and suggested that doctors should consider stopping treatment among users diagnosed with pigmentary maculopathy.
October 12, 2019
A new study was presented at the 2019 Annual Meeting of the American Academy of Ophthalmology, indicating that about 25% of patients with significant exposure to Elmiron shows retinal damage signals.
Three California ophthalmologists reviewed records from a database involving millions of patients, and found 140 patients who had taken an average of 4,000 Elmiron pills over a period of 15 years. 91 of the 140 patients agreed to come in for an eye exam, and about one-quarter (22) showed clear signs of drug toxicity. In the late stages, the retina toxicity can mimic age-related macular degeneration (AMD) and result in permanent vision loss.
November 6, 2019
A retrospective analysis of data from a large U.S. medical claims database was published by the British Journal of Ophthalmology, indicating that at a 7 year analysis, Elmiron users had significantly increased odds of having atypical maculopathy or a new diagnosis of macular disease.
Case report published by Harvard researchers in Ophthalmic Surgery, Lasers and Imaging Retina described a case of Elmiron maculopathy that continued to worsen over six years after stopping use of the drug.
The researchers indicated that after using 200mg of Elmiron for 18 years, a 62 year old woman stopped taking the drug after developing vision problems. However, over the next six years, she continued to suffer increasing vision damage.
In the American Journal of Ophthalmology Case Reports, researchers with Kaiser Permanente described a case of eye problems from Elmiron misdiagnosed as Stargardt disease, which is a genetic form of retina deterioration.
A 41 year old woman sought a second opinion after suffering darkening vision, progressive difficulty reading and loss of night vision. Genetic testing was negative and the woman was diagnosed with PPS maculopathy from Elmiron, highlighting the importance of doctors considering medications of those with retinal damage.
Study published in the medical journal Clinical Opthalmology identified a distinct signature of Elmiron-associated maculopathy, which can be detected through multimodal imaging by an ophthalmologist.
Researchers at University of California, Los Angeles published a study in the Canadian Journal of Opthalmology, finding that 20% (1 out of 5) long-term users had evidence of Elmiron retina damage.
No Fees or Expenses Unless You Receive an Elmiron Settlement
All Elmiron vision loss cases are being handled by our law firm on a contingency fee basis, which means that there are never any out-of-pocket costs to hire our lawyers and we receive no attorney fees or expenses unless a recovery is obtained.
Saiontz & Kirk, P.A. is a nationally known injury law firm that is focused exclusively on representing individuals, we do not represent corporations or insurance companies.
Over the course of more than 45 years, clients of our law firm have collected more than $1 billion in compensation in cases involving product liability, medical malpractice, automobile accidents and other personal injury lawsuits.
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