Elmiron Vision Loss Lawsuit
Have you or a loved one suffered from retinal damage, vision loss, blindness, pigmentary maculopathy, or other eye problems?
Lawyers at the Willis Law Firm can help!
Long-term use of bladder drug Elmiron has been linked to pigmentary maculopathy, a degenerative eye disease. Prolonged use could lead to progressive vision loss and blindness. Individuals who have been diagnosed with macular degeneration or another retinal disease after experiencing blurry vision, loss of night vision, dark spots, blindness, loss of vision detail, and difficulty reading.
Studies suggest that long-term use of at least 6 months of Elmiron may cause maculopathy, an eye disorder that could lead to blindness. Janssen Pharmaceuticals, the maker of Elmiron, failed to warn patients about the full dangers of taking the drug, including the risk of blindness or macular degeneration.
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On June 17, 2020, the FDA announced that new Elmiron Retinal Damage warnings be added to the label for all medical professionals and patients.
ELMIRON WARNINGS Retinal Pigmentary Changes
Pigmentary changes in the retina, reported in the literature as pigmentary maculopathy, have been identified with long-term use of ELMIRON® (see ADVERSE REACTIONS). Although most of these cases occurred after 3 years of use or longer, cases have been seen with a shorter duration of use. While the etiology is unclear, cumulative dose appears to be a risk factor.
Visual symptoms in the reported cases included difficulty reading, slow adjustment to low or reduced light environments, and blurred vision. The visual consequences of these pigmentary changes are not fully characterized. Caution should be used in patients with retinal pigment changes from other causes in which examination findings may confound the appropriate diagnosis, follow-up, and treatment. Detailed ophthalmologic history should be obtained in all patients prior to starting treatment with ELMIRON®. If there is a family history of hereditary pattern dystrophy, genetic testing should be considered. For patients with pre-existing ophthalmologic conditions, a comprehensive baseline retinal examination (including color fundoscopic photography, ocular coherence tomography (OCT), and auto-fluorescence imaging) is recommended prior to starting therapy. A baseline retinal examination (including OCT and auto-fluorescence imaging) is suggested for all patients within six months of initiating treatment and periodically while continuing treatment. If pigmentary changes in the retina develop, then risks and benefits of continuing treatment should be re-evaluated, since these changes may be irreversible. Follow-up retinal examinations should be continued given that retinal and vision changes may progress even after cessation of treatment.
Elmiron Side Effects
Elmiron is the only FDA approved drug to treat interstitial cystitis or bladder pain syndrome. Also known as Pentosan Polysulfate Sodium (PPS), the brand sold under Janssen is Elmiron. Elmiron was approved by the US Food and Drug Administration (FDA) in 1995 and has sales in excess of $150 million each year. Sold and branded as a safe and effective drug for bladder and pelvic pain, more scientific evidence suggests there is a link between Elmiron and macular degeneration and eye diseases that result in irreversible retina damage, vision loss, and blindness. Elmiron lack the warnings of the serious vision loss and the high risk of pigmentray maculopathy.
Elmiron was developed for individuals suffering from interstitial cystitis which involves severe bladder pressure, bladder pain, and occasionally pelvic pain. Most refer to the three as “painful bladder syndrome.” It is most common among women. In some instances, painful bladder syndrome is mistaken for a urinary tract infection (UTI), but it is actually a chronic condition that does not have a cure. This leads to many women using Elmiron for years and years.
What are symptoms of maculopathy?
Patients that have taken Elmiron and developed maculopathy usually report vision problems as their first symptom. Ophthalmologists typically associate Elmiron with maculopathy symptoms like:
- Difficulty reading
- Taking a long time to adjust to the dark
- Difficulty seeing close objects
- Dimming of vision
- Paracentral scotoma
- Blurring of vision
- Eye Pain
- Irreversible Eye damage such as blindness