The Elmiron lawsuit claims that long-term exposure to Elmiron causes maculopathy, an eye disorder affecting the macula (central part of the retina) and a major cause of blindness.
What Do We Know About the Elmiron Lawsuits?
Elmiron is utilized to treat a condition known as interstitial cystitis, better known as “painful bladder syndrome.” It is also prescribed for osteoarthritis in humans as well as elderly dogs and horses. At one time, Elmiron was used as an anticoagulant, similar to warfarin, but with a weaker effect.
In 2018, an article was published by the American Academy of Ophthalmology in which the authors wrote about six patients treated at Emory Eye Center between 2015 and 2017 who experienced pigmentary maculopathy of unclear cause following chronic exposure to Elmiron (pentosan polysulfate sodium) for interstitial cystitis.
In 2019, one of the authors issued an update writing that ten patients at Emory Eye Center had been diagnosed with this same issue.
What Do We Know About Maculopathy and Elmiron?
Maculopathy is a general term referring to any pathological condition that affects the macula, the central portion of the retina upon which visual acuity and sensitivity depends. Types of maculopathy include:
- Age-Related Macular Degeneration: a degenerative condition that develops over time, resulting in gradual sight loss, starting in the central field of vision.
- Cellophane Maculopathy: also known as “macular pucker.” This results from the formation of a thin, transparent layer of scar tissue that pulls on the light-receptive nerve cells of the macula, causing visual distortion.
- Malattia Leventinese: also known as “Doyne Honeycomb Retinal Dystrophy" or DHRD. This condition is a congenital (inherited) form of macular degeneration which begins with small, pale spots in the macula that eventually grows into a honeycomb pattern.
The form of macular degeneration that has been linked with Elmiron is identified as “pigmentary maculopathy of unknown etiology”. It is a macular injury with no known cause. Presentation of the condition differs slightly from one patient to another, but symptoms include any or all of the following:
- parafoveal pigmented deposits: capillaries and small blood vessels around the macula become abnormal, resulting in vision loss.
- vitelliform deposits: round, yellowish lesions that form underneath the macula (also known as adult pattern macular dystrophy).
- retinal pigment epithelium atrophy: a common symptom of age-related macular degeneration.
Patients may also present with hyperpigmented, or darkened spots, on the retina during an eye examination.
Other Adverse Effects of Elmiron
Patients who have been prescribed Elmiron have reported one or more of the following side effects:
- alopecia (hair loss)
- gastroesophageal reflux
- skin rash
- sleep disorders
Between 1997 and 2019, 100 cases identified as “eye disorders” among Elmiron patients were filed with the FDA Adverse Event Reporting System (FAERS). Eighty of these were classified as serious. At least 22 of these reports mentioned some form of maculopathy.
Elmiron product labeling does not include any language describing pigmentary maculopathy or any other form of maculopathy. The only references to any form of ocular or vision-related disorders are located within the Adverse Reactions section, referring to nystagmus, conjunctivitis, optic neuritis, amblyopia, and retinal hemorrhage observed in premarket clinical trials. The labeling includes no relevant warnings and identifies no relevant adverse events observed in the post-marketing setting.