Elmiron Side Effects & Lawsuits

Elmiron (pentosan polysulfate) is a medication approved by the FDA in 1996 to treat interstitial cystitis, a painful bladder condition.

Interstitial Cystitis (IC)

IC, also known as painful bladder syndrome, is a chronic condition characterized by bladder pain, urinary urgency, frequency, and nighttime urination (nocturia). Details are described below:¹

• The exact cause of IC is unknown, but it is believed to involve damage to the bladder lining.
• Studies suggest that a layer of protective polysaccharide molecules (called glycosaminoglycans) normally shields the bladder lining. Polysaccharides are complex carbohydrates made up of many sugar molecules bonded together,
• In IC, this protective layer is compromised, allowing leakage of urine and irritants into the bladder wall, causing pain and inflammation.

Elmiron's Potential Mechanism in IC Treatment

Elmiron (pentosan polysulfate) is a synthetic polysaccharide structurally similar to natural bladder lining glycosaminoglycans. Details are described below:²

• While the exact mechanism is unclear, Elmiron is believed to bind to the damaged bladder wall, forming a protective barrier.
• This potential barrier restoration may explain Elmiron's effectiveness in treating IC.

Concerns have emerged regarding an association between use of Elmiron and development of an eye disease, as described below:

• Recent independent studies (first published by Emory) suggest a potential link between long-term Elmiron use and a new eye disease called pigmentary maculopathy (PM).³
• PM is a condition that changes the color of the retina, the eye's light-sensitive tissue at the back of the eye responsible for transmitting visual signals to the brain. This can lead to vision problems, ranging from mild to severe, including partial or total loss of vision in certain areas.

Correlations Between Elmiron Use and PM

The current understanding of the Elmiron-PM relationship is based on retrospective studies examining long-term Elmiron users for signs of PM.

• A recent landmark study suggests a correlation between Elmiron use duration and PM risk.⁴ The risk appears to be particularly elevated for patients taking Elmiron for seven years or more.
• This correlation is supported by a Canadian study where PM patients had been taking the drug for an average of 15 years.⁵
• A UCLA cross-sectional study identified cumulative Elmiron dosage as another potential factor. A total exposure of 1,500 grams or more was linked to a stronger association with PM.⁶

Both sex and age influence the risk of developing IC/PBS and Elmiron-induced pigmentary maculopathy (PM) as follows:

Gender Disparity in IC/PBS and Elmiron Use

Interstitial cystitis/painful bladder syndrome (IC/PBS) disproportionately affects females, as can be seen in the following statistics:

• Studies report a prevalence of up to 197 cases per 100,000 women compared to 41 cases per 100,000 men.⁷
• Clinical trials for Elmiron reflect this gender disparity, with significantly higher recruitment of female participants (2220) compared to males (254).⁷
• An analysis by Ludwig et al. further supports this trend, finding that nearly 90% of 49,899 IC/PBS patients were female.⁶

Age Considerations in IC/PBS and Elmiron-induced PM

Elmiron-induced PM is more likely at an older age, even though the average age of IC/PBS is much younger, as described below:

• FDA data suggests that females with an average age of 47 are most commonly diagnosed with IC/PBS and thus more likely to be Elmiron users.¹
• However, studies investigating Elmiron-linked PM report an average patient age of 60 (e.g., Hanif et al. study with 35 confirmed PM diagnoses).⁸

Pre-existing eye problems and medications that harm the retina make it hard to show a direct connection between Elmiron and pigmentary maculopathy (PM), which also affects vision by damaging the retina.

Pre-existing eye conditions

Certain pre-existing eye conditions can mimic the symptoms of PM, potentially leading to misdiagnosis or complicating eligibility in Elmiron-related lawsuits. These conditions include:

• Age-related macular degeneration (AMD) - both dry and wet forms
• Hereditary maculopathies like Stargardt macular degeneration and Vitelliform macular dystrophy
• Diabetic maculopathy - a complication of diabetes where damage occurs to the central part of the retina, leading to potential vision loss

Multiple Medications and Establishing Elmiron Causation

Several medications can cause various forms of maculopathy or retinal damage, making it more difficult to isolate Elmiron as the sole cause of PM when these other medications are also being used. Examples of retinal conditions associated with medication use are as follows:⁹

• Pigmentary toxicity - this is damage to the pigment (colored) cells in the retina that play a crucial role in vision (e.g., Clofazimine, hydroxychloroquine).
• Crystalline retinopathy - this condition involves formation of crystals within the retina, disrupting its function (e.g., Canthaxanthin, methoxyflurane).
• Photoreceptor dysfunction - this refers to abnormal function of light-sensitive cells (photoreceptors), impairing vision (e.g., Carmustine, cisplatin).
• Macular edema - this condition involves fluid accumulation in the macula, causing blurred vision (e.g., Fingolimod, Latanoprost).
• Central serous choroidopathy - this condition involves fluid leakage from the choroid (a layer beneath the retina), distorting vision (e.g., corticosteroids).
• Uveitis - this is inflammation of the uveal tract (middle layer of the eye) causing pain, light sensitivity, and vision loss (e.g., Dabrafenib, pembrolizumab).
• Retinal vascular damage - this condition is characterized by disruption of blood flow to the retina due to damage in blood vessels, leading to vision problems (e.g., aminoglycoside antibiotics)

Several recent lawsuits highlight the emerging legal landscape surrounding Elmiron and potential pigmentary maculopathy (PM) development:^10,11,12,13

• Cukierski v. Janssen Pharmaceuticals, Inc., et al.: This recently filed lawsuit claims long-term Elmiron use resulted in ophthalmic injuries (eye injuries) or other unspecified injuries.
• Friedman et al v. Janssen Pharmaceuticals, Inc., et al.: This case alleges similar injuries from long-term Elmiron use. A "conditional transfer order" suggests the case may be consolidated with other similar lawsuits in a different jurisdiction.
• Reedy v. Janssen Pharmaceuticals, Inc., et al.: Recently filed, this lawsuit alleges ophthalmic injuries and potentially other unspecified injuries stemming from long-term Elmiron use.
• Troutman v. Janssen Pharmaceuticals, Inc., et al.: This recently filed case alleges long-term Elmiron use caused ophthalmic injuries or other unspecified injuries.