Patients taking Elmiron may develop a rare but serious eye disease called retinal maculopathy
What is Elmiron?
Elmiron (also known as pentosan polysulfate sodium, or PPS) is a drug prescribed to treat osteoarthritis and interstitial cystitis, or “painful bladder syndrome.”
Eye Damage Associated with Elmiron
Recent studies show that patients taking Elmiron may develop a rare but serious eye disease called retinal maculopathy. Similar to macular degeneration, this condition alters pigment cells in the retina, changing the eye color while causing significant eye damage and vision loss.
Symptoms for patients experiencing Elmiron-associated eye damage include:
- Change in eye color
- Blurred vision
- Difficulty reading
- Difficulty adapting to dim lighting
- Dark spots in center of vision
- Straight lines appearing curved or squiggly
- Muted, less vivid colors
In 2017 the Emory Eye Center in Atlanta, Georgia began studying a new eye disease, “retinal maculopathy” in patients. Emory discovered that every patient in the study with this eye disease had been taking Elmiron. Shortly thereafter, Kaiser Oakland found even more patients in their database with retinal maculopathy and eye damage who has taken Elmiron. In December 2019, the Interstitial Cystitis Network conducted a survey of its members taking Elmiron, and the results were shocking: over half of the patients on Elmiron who participated in the study suffered from retinal disease.
The Manufacturer Knew of the Link Between Elmiron and Eye Damage
While the medical community has only recently learned of this connection, Elmiron’s manufacturer Janssen has known of the link between Elmiron and eye damage for over 20 years. In early clinical trials of patients who took Elmiron for up to four years, both vision and eye related adverse events were reported.
Although Janssen knew of the link between Elmiron and eye damage for more than 20 years, the company never added warnings to the label or conducted further research on the link between Elmiron and eye damage. Instead, they ignored the risks and went on to earn billions of dollars selling Elmiron. Now they are facing thousands of lawsuits from patients that suffered severe eye damage. If you have taken Elmiron and experienced eye damage, contact us today.
Drug manufacturers are responsible for ensuring the safety and efficacy of their products before marketing them for public consumption. Failure to do so is considered negligent and grounds for litigation. The attorneys of Aylstock, Witkin Kreis & Overholtz handle litigation across the United States for victims injured by defective pharmaceuticals and medical devices. We have successfully represented and obtained substantial compensation for thousands of patients who have been harmed by prescription drugs.
If you believe that you may have suffered vision loss or have been diagnosed with macular degeneration or a similar condition, please call us today at 1-877-810-4808 or email us at ElmironClaim@awkolaw.com so that we may provide you with addition information about your legal rights.
Bibliography and References
Greenelee, T., et al. (2019). Re: Pearce et al.: Pigmentary Maculopathy Associated with Chronic Exposure to Pentosane Polysulfate Sodium, Ophthalmology, 126(7), e51, DOI: 10.1016/j.ophtha.2018.12.037. Available at: https://www.ncbi.nlm.nih.gov/pubmed/31229012
Hanif, A., et al. (2019). Strength of Association between Pentosal Polysulfate and a Novel Maculopathy, Ophthalmology, 126(10), 1464-1466, DOI: 10.1016/j.ophtha.2019.04.024. Available at: https://www.ncbi.nlm.nih.gov/pubmed/31004677
Jain, N., et al. (2019). Association of Macular Disease with Long-Term Use of Pentosan Polysulfate Sodium: Findings from a US Cohort, Br J Ophthalmol, 1-5, DOI: 10.1136/bjophthalmol-2019-314765. Available at: https://www.ncbi.nlm.nih.gov/pubmed/31694837
Ludwig, C., et al. (2019). Pentosan Polysulfate Sodium Exposure and Drug-Induced Maculopathy in Commercially Insured Patients in the United States, Ophthalmology, 127(4), 1-5, DOI: 10.1016/j.ophtha.2019.10.036. Available at: https://www.ncbi.nlm.nih.gov/pubmed/31899034
Pearce, W., et al. (2018). Pigmentary Maculopathy Associated with Chronic Exposure to Pentosan Polysulfate Sodium, Ophthalmology, 125, 1793-1802, DOI: 10.1016/j.ophtha.2018.04.026. Available at: https://www.ncbi.nlm.nih.gov/pubmed/29801663
Vora, R., et al. (2020). Prevalence of Maculopathy Associated with Long-Term Pentosan Polysulfate Therapy, Ophthalmology, 1-2, DOI: 10.1016/j.ophtha.2020.01.017. Available at: https://www.ncbi.nlm.nih.gov/pubmed/32085877
Wang, D., et al. (2019). Pentosan-Associated Maculopathy: Prevalence, Screening Guidelines, and Spectrum of Findings Based on Prospective Multimodal Analysis, Can J Ophthalmol, 19, 31272-4, DOI: 10.1016/j.jcjo.2019.12.001. Available at: https://pubmed.ncbi.nlm.nih.gov/31973791/
Wein, A., et al. (2020). Re: Pigmentary Maculopathy Associated with Chronic Exposure to Pentosan Polysulfate Sodium, J Urol, 203(2), 259-260, DOI: 10.1097/01.JU.0000614920.84680.c7. Available at: https://pubmed.ncbi.nlm.nih.gov/31721679/
Aylstock, Witkin, Kreis & Overholtz is a national law firm geared towards protecting the rights of consumers who are seriously injured as a result of defective products, defective medical devices, accidents, or other negligent behavior.
The lawyers representing Aylstock, Witkin, Kreis & Overholtz are licensed to practice law in fourteen states (FL, AL, MS, LA, TX, CO, MN, PA, NY, NJ, NV, MT, WA, OH), with associated counsel in all remaining states. Aylstock, Witkin, Kreis & Overholtz is a national leader in fighting for consumer justice.
Aylstock, Witkin, Kreis & Overholtz
17 E. Main Street, Suite 200
Pensacola, Florida 32502
Phone: (850) 202-1010
Toll Free: (844) 794-7402
Fax: (850) 916-7449
Post Office Box 12630
Pensacola, Florida 32591