New Jersey, June 9, 2020 – Levy Konigsberg LLP and Napoli Shkolnik PLLC have filed a products liability lawsuit in the Superior Court of New Jersey, Middlesex County, against the manufacturers of Elmiron, a prescription drug used to treat interstitial cystitis (bladder pain), for failing to warn plaintiff Valerie Hull of the risks of retinal damage. Mrs. Hull is represented by Corey Stern of Levy Konigsberg LLP and Hunter Shkolnik of Napoli Shkolnik PLLC. The complaint names Janssen Pharmaceuticals and several other Johnson & Johnson and Teva Pharmaceuticals entities as defendants who manufactured marketed and distributed the drug.
Mrs. Hull used Elmiron (pentosan polysulfate sodium) from approximately 2001 until 2018 and is considered to be “patient zero” in a 2018 Emory Eye Center study. While under the care of ophthalmologist Nieraj Jain and after undergoing a series of vision exams, Dr. Jain recommended that Mrs. Hull participates in a case study. Five other patients who were displaying similar eye issues were also added to the study. Each patient was being treated for interstitial cystitis with the drug Elmiron. Researchers found a new eye disease, retinal maculopathy, in all six patients.
Retinal maculopathy is a pathological disease of the macula (a small spot in the retina that is associated with highly sensitive, accurate vision). The pigment cells within the retina change color and can cause significant eye dysfunction. Other studies since the Emory Eye Center study have found that Elmiron may lead to an increased risk of retinal maculopathy, often diagnosed as retinal pigmentary maculopathy, pattern dystrophy, or age-related macular degeneration. In a Kaiser study, 24% of patients showed drug-induced retinal maculopathy. In an IC Network survey of 1,604 Elmiron patients, almost 54% had a retinal disease.
Patients who have used Elmiron should be routinely screened by an optometrist or ophthalmologist for retinal damage.
Common symptoms of eye damage associated with retinal maculopathy include:
- Blurred vision;
- Central vision loss;
- Poor light to dark adaptation;
- Difficulty reading;
- Dark spots; and
- Other vision irregularities.
Pearce WA, Chen R, Jain N. Pigmentary maculopathy associated with chronic exposure to pentosan polysulfate sodium. Ophthalmology 2018; 125: 1793-1802. https://doi.org/10.1016/j.ophtha.2018.04.026
Foote, et al. Chronic Exposure to Pentosan Polysulfate Sodium is Associated with Retinal Pigmentary Changes and Vision Loss. AUA 2019 Abstract MP47-03.
American Academy of Ophthalmology. More evidence linking common bladder medication to a vision-threatening eye condition: New study shows about a quarter of patients with significant exposure to the drug show signs of retinal damage. Science Daily; 12 October 2019. Available at: www.sciencedaily.com/releases/2019/10/191012141218.htm.
Jain N, Li AL, Yu Y, et al. Association of macular disease with long-term use of pentosan polysulfate sodium: Findings from a U.S. cohort. Br J Ophthalmology 2019 Nov 6. [Epub ahead of print]. https://doi.org/10.1136/bjophthalmol-2019-314765
Canadian Journal of Ophthalmology | January 2020 | Derrick Wang, Adrian Au, Frederic Gunnemann, “Pentosan-associated maculopathy: prevalence, screening guidelines, and spectrum of findings based on prospective multimodal analysis.”
Huckfeldt, et al. Progressive Maculopathy After Discontinuation of Pentosan Polysulfate Sodium. Opthalmic Surgery, Lasers & Imaging Retina. 2019; 50 (10): 656-659.
Vora RA, Patel AP, Melles R, Prevalence of Maculopathy Associated with Long Term Pentosan Polysulfate Therapy Ophthalmology (2020), doi: https://doi.org/10.1016/j.ophtha.2020.01.017.
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