Elmiron-Related Eye Injuries and Vision Problems

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Have you taken the prescription drug Elmiron and experienced vision problems? Our lawyers are ready to assist you. 

Robins Kaplan LLP is investigating reports of vision problems and eye injuries associated with use of the drug Elmiron. If you were prescribed Elmiron and developed an eye injury or vision problem, please contact us at 1.800.610.7562 for a free evaluation. 

Elmiron is a drug prescribed to treat interstitial cystitis (also known as painful bladder syndrome). Manufactured by Janssen, Elmiron is the brand name for a drug called pentosan polysulfate sodium.

On June 16, 2020, the FDA approved a label change for Elmiron warning that the drug has been linked with pigmentary changes in the retina, including pigmentary maculopathy. The new warning label states that “cumulative dose appears to be a risk factor.”1

Pigmentary maculopathy affects the central part of the retina, can permanently impair vision, and can cause a range of symptoms, including:

  • Central vision loss
  • Blurred, dimmed, or spotty vision
  • Difficulty reading
  • Difficulty adjusting to low light or changes in lighting
  • Pain in the eye 

While it is currently unclear how long the manufacturers of Elmiron had data supporting a change to Elmiron’s package insert, since at least 2018, several peer-reviewed medical journals have linked Elmiron with eye injuries. Unfortunately, many Elmiron consumers ingested Elmiron for years without being alerted to these risks.

Specifically, articles and case studies that continue to be published through 2020 have linked Elmiron to pigmentary maculopathy or macular degeneration. Examples of medical journals that have published on Elmiron and pigmentary maculopathy include:

  • Ophthalmology (four articles)2
  • JAMA Ophthalmology (two articles)3
  • The British Journal of Ophthalmology4
  • The American Journal of Ophthalmology5
  • Review of Ophthalmology6
  • The Canadian Journal of Ophthalmology7
  • The Canadian Urological Association Journal8
  • The Journal of Urology9
  • Ophthalmic Surgery, Lasers & Imaging Retina10
  • Urology11

Additional medical journal articles regarding Elmiron and pigmentary maculopathy are pending publication later in 2020.

How Robins Kaplan Law Firm Can Help With Your Elmiron Lawsuit

Our nationally recognized mass tort attorneys assist clients who are seriously injured by dangerous and defective products, and we are available to evaluate your potential claim against the manufacturers of Elmiron.

Robins Kaplan’s medical and pharmaceutical attorneys have the experience to take on big drug companies. Our team of attorneys, registered nurses, paralegals, and case assistants will thoroughly investigate your case, doing the following as needed:

  • Upon commencement of legal representation, one of our attorneys, legal nurses, or paralegals will call you and discuss your relevant medical history and prescription drug use.
  • We will order and review your medical and pharmaceutical records, and we will determine if you took a potentially harmful drug, and we will evaluate whether that drug hurt you.
  • Our pharmaceutical lawyers will compare the laws of your state with the timeline of events, including, key dates in your medical timeline and dates of certain acts or omissions by the medicine manufacturer, and we will plan the best litigation strategy for your case.
  • We will investigate whether the drug manufacturer complied with FDA regulations and whether the manufacturer warned you about risks and side-effects associated with the drug.

Throughout the entire process, our legal team will keep you informed about your case. Contact us for a free and confidential evaluation today. To get started, call 1.800.610.7562 or fill out our online contact form above.

Trouble reading this page? Below is an Audio-Visual option for information on Elmiron.

1 U.S. Food and Drug Administration, June 16, 2020 Supplemental Elmiron Package Insert. Drugs@FDA, available at https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020193s014lbl.pdf.
2 Hanif AM, et al. Strength of Association between Pentosan Polysulfate and a Novel Maculopathy. Ophthalmology. 2019 Oct;126(10):1464-1466. doi: 10.1016/j.ophtha.2019.04.024. Epub 2019 Apr 18; Ludwig CA, et al. Pentosan Poloysulfate Sodium Exposure and Drug-Induced Maculopahty in Commercially Insured Patients in the United States. Ophthalmology. 2019 Nov. 2020 Apr;127(4):535-543. doi: 10.1016/j.ophtha.2019.10.036. [Epub 2019 Nov 5];
Pearce WA, Chen R, Jain N. Pigmentary Maculopathy Associated with Chronic Exposure to Pentosan Polysulfate Sodium. Ophthalmology. 2018 Nov;125(11):1793-1802; Vora RA, et al. Prevalence of Maculopathy Associated with Long-Term Pentosan Polysulfate Therapy. 2020 Jun;127(6):835-836.
 doi: 10.1016/j.ophtha.2020.01.017. [Epub 2020 Jan 17].
3 Hanif AM, Armenti ST, Taylor SC, et al. Phenotypic Spectrum of Pentosan Polysulfate Sodium-Associated Maculopathy: A Multicenter Study. JAMA Ophthamol. 2019 Sep 5. Doi: 10.1001/jamaophthalmol.2019.3392. [Epub ahead of print]; Shah R, et al. Disease Course in Patients With Pentosan Polysulfate Sodium-Associated Maculopathy After Drug Cessation. JAMA Ophthamol. July 9, 2020. doi:10.1001/jamaophthalmol.2020.2349.
4 Jain N, Li AL, Yu Y, VanderBeek BL. Association of macular disease with long-term use of pentosan polysulfate sodium: findings from a US cohort. Br J Ophthalmol. 2019 Nov 6. Doi: 10.1136/bjophthalmol-2019-314765. [Epub ahead of print].
5 Vora RA, et al. Case Reports: A case of pentosane polysulfate maculopathy originally diagnosed as stargardt disease. Am. J. Ophthalmology. 2020 Jan 25;17:100604.
6 Hanif AM, Jain N. Clinical Pearls for a New Condition: Pentosan polysulfate therapy, a common treatment for interstitial cystitis, has been associated with a maculopathy. Review of Ophthalmolgy. 2019 July 10.
7 Wang D, et al. Pentosan-associated maculopathy: prevalence, screening guidelines, and spectrum of findings based on prospective multimodal analysis. Can J Ophthalmol. Jan. 20, 2020; doi: 10.1016/j.jcjo.2019.12.001.
8 Doiron RC, et al. Possible drug-induced, vision-threatening maculopathy secondary to chronic pentosane polysulfate sodium (Elmiron) exposure. Can Urol Assoc J. 2020;14(2):10-1. http://dx.doi.org/10.5489/cuaj.6401.
9 Foote J, et al. Chronic Exposure to Pentosan Polysulfate Sodium is Associated with Retinal Pigmentary Changes and Vision Loss. J Urol. Vol. 201, No. 4S, Supplement, Sunday, May 5, 2019.
10 Huckfeldt R., et al. Progressive Maculopathy After Discontinuation of Pentosan Polysulfate Sodium. Ophthalmic Surgery, Lasers & Imaging Retina. 2019;50(10):656-659.
11 Wingelaar M., et al. Retinal Toxicity in a Patient on Pentosan Polysulfate Sodium. Urology. 141: e41−e42, 2020; Doi.org/10.1016/j.urology.2020.04.006.