Elmiron may cause the serious eye disease pigmentary maculopathy in one out of four patients who take the bladder drug. Pigmentary maculopathy can lead to such vision problems as seeing dark spots, blurriness, and even blindness. The higher the dose and the longer the treatment, the higher the odds of developing eye damage from Elmiron.
Shouse Law Group is suing Elmiron manufacturer Janssen Pharmaceuticals for failing to warn doctors and patients about the link between the drug and retinal damage. Our Elmiron lawsuits are seeking monetary awards to pay for our clients’ medical bills, lost wages, loss of future earnings, and pain and suffering.
In this article, our Elmiron attorneys discuss:
- 1. What is pigmentary maculopathy?
- 2. Does Elmiron cause pigmentary maculopathy?
- 3. Has Elmiron been recalled?
1. What is pigmentary maculopathy?
The eye disorder pigmentary maculopathy is a type of maculopathy specifically linked to Elmiron usage. Maculopathy, in turn, is a progressive eye condition that may lead to vision impairment. It typically affects both eyes.
The macula is a 5 mm area located in the rear of the retina containing many photoreceptor cells (which detect light). The brain interprets the signals sent by the macula as images. The macula is responsible for:
- focusing central vision (as opposed to side/peripheral vision, which is processed by the rest of the retina),
- recognizing faces,
- recognizing colors,
- recognizing fine details, and
People who develop pigmentary maculopathy typically exhibit some or all of the following eleven abnormalities:
- Having dark spots (a.k.a. hyper-pigmented spots) on the retina
- Retinal pigment epithelium atrophy
- Yellowish, roundish lesions beneath the macula (a.k.a. vitelliform deposits or adult pattern macular dystrophy)
- Abnormal blood vessels and capillaries (a.k.a. parafoveal pigmented deposits)
- Night blindness
- Blindness (loss of vision)
- Seeing dark spots
- Lack of close vision
- Blurred vision
- Difficulty reading
To diagnose pigmentary maculopathy, eye doctors may administer the following tests:
- Eye chart tests (visual acuity tests), which measures the patient’s ability to see
- Amsler grid, which can be used for home-monitoring
- Dilation, which allows doctors to see the back of the retina
- Fundoscopy, where the doctor aims a beam of light into the dilated eye
- Autofluorescence, which are photos that monitor the retina’s deepest layer called the RPE (retinal pigment epithelium)
- Fundus photography to take an image of the back of the eye
- OCT (optical coherence tomography), which is a cross-sectional image of the retina
- Tonometry, which measures eye pressure
- Fluorescein angiography, which detects leaking blood vessels1
2. Does Elmiron cause pigmentary maculopathy?
Probably. The following six studies show evidence that about 25% of people who take the drug Elmiron for six months or more develop the eye disease:
- Emory Eye Center study (May 2018): Six Elmiron patients developed pigmentary maculopathy.2
- Second Emory Eye Center study (April 2019): A study of 10 patients showed that people with interstitial cystitis who did not take Elmiron did not develop pigmentary maculopathy.3
- Kaiser Permanente study (October 2019): Of 91 Elmiron patients, 22 showed signs of toxicity. People who took more of the drug exhibited more toxicity.4
- Jain study (November 2019): Patients who took Elmiron for seven years had higher odds of macular disease than those who took Elmiron for five years.5
- Huckfeldt and Vavvas study (November 2019): A patient continued to get worsening pigmentary maculopathy even six years after stopping Elmiron.6
- Vora, Patel and Melles study (January 2020): 27 of 117 Elmiron users developed pigmentary maculopathy. Patients who took more than 1,500 grams were at greater risk.7
It is unclear exactly why Emiron’s active ingredient pentosan polysulfate sodium (PPS) can harm some patients’ maculas. Many Elmiron patients who develop pigmentary maculopathy are misdiagnosed by ophthalmologists as having pattern dystrophy or late-stage dry atrophic age-related macular degeneration.
3. Has Elmiron been recalled?
No. Elmiron remains on the market despite the mounting litigation by patients who developed permanent vision loss and various other side effects after taking the drug as prescribed.
Instead, Janssen added a warning label to its packaging that concedes:
Pigment changes in the retina of the eye (also referred to as pigmentary maculopathy in medical journal articles) have been reported with long-term use of ELMIRON®. While the cause of the pigmentary changes is unclear, continued long term dosing with ELMIRON® may be a risk factor.8
Elmiron is currently the only FDA (Food and Drug Administration) approved bladder medication to treat interstitial cystitis (a.k.a. painful bladder syndrome or bladder pain syndrome). This bladder condition causes severe bladder pain, pelvic pain, and urinary problems. Urologists often prescribe Elmiron when less aggressive treatments have not worked.
Disclaimer: Past results do not guarantee future results.
- See Dry Macular Degeneration, Mayo Clinic. Macular Degeneration: Screening and Diagnosis, Bright Focus Foundation.
- William A. Pearce, Rui Chen, Nieraj Jain, Pigmentary Maculopathy Associated with Chronic Exposure to Pentosan Polysulfate Sodium, American Academy of Ophthalmology (May, 2018).
- Jenelle Foote, Adam Hanif, And Nieraj Jain, Chronic Exposure To Pentosan Polysulfate Sodium Is Associated With Retinal Pigmentary Changes And Vision Loss, Journal of Urology (April, 2019).
- Robin A Vora MD, Presentation: Prevalence of Maculopathy Associated With Pentosan Polysulfate Therapy in Kaiser Permanente Northern California, AAO (October 2019).
- Nieraj Jain, Alexa L Li, Yinxi Yu, Brian L VanderBeek, Association of macular disease with long-term use of pentosan polysulfate sodium: findings from a US cohort, British Journal of Ophthalmology (November, 2019).
- Rachel M. Huckfeldt, Demetrios G. Vavvas, Progressive Maculopathy After Discontinuation of Pentosan Polysulfate Sodium, Ophthalmic Surgeries, Lasers, and Imaging Retina (November 6, 2019). See also Rachel Shah; Joseph M. Simonett; Riley J. Lyons, et al, Disease Course in Patients With Pentosan Polysulfate Sodium–Associated Maculopathy After Drug Cessation, JAMA Ophthalmology (July 9, 2020)
- Robin A. Vora, Amar P. Patel, Ronald Melles, Prevalence of Maculopathy Associated with Long-Term Pentosan Polysulfate Therapy, AAO (January 16, 2020).
- Elmiron Prescribing Information.