Significant Risk of Eye Damage from Elmiron Highlighted in Study

As a growing number of Elmiron lawsuits continue to be filed throughout the U.S. court system by former users of the bladder drug left with permanent eye damage, the findings of a new study suggest 20% of long-term users of the medication may have the unique retinal injury associated with the medication.

Elmiron (pentosan polysulfate sodium or PPS) is a prescription medication which has been on the market since 1996, for treatment of interstitial cystitis or “painful bladder syndrome”. Since there is no cure for this condition, many users have remained on the drug for years, if not decades, unaware they may be causing irreversible damage to their eye sight and vision.

In June 2020, the Elmiron warning label was updated to provide information about potential vision risks for the first time, indicating a number of users have been diagnosed with a retinal condition as pigmentary maculopathy, which can result in blurry vision, dark spots, difficulty adjusting in dim light, as well as blindness. However, increasing evidence suggests the drug makers knew or should have known about this risk, and withheld warnings and information from consumers, urologists and ophthalmologists.

According to new findings published in the April 2021 issue of the Canadian Journal of Ophthalmology, the eye damage from Elmiron may be much more widespread than prior warnings have suggested.

Researchers with the University of California, Los Angeles (UCLA) say one out of five users of the interstitial cystitis, who took Elmiron for two decades on average, developed maculopathy, and indicate a series of imaging tests can accurately identify the condition.

In this study, researchers used multimodal imaging scans to detect the Elmiron eye problems, which is increasingly referred to as PPS-related maculopathy; referring to the active pharmaceutical ingredient in the medication.

All of the patients examined were currently or previously treated at UCLA, where researchers calculated their daily and cumulative doses of Elmiron exposure and conducted near-infrared reflectance (NIR) scans, fundus autofluorescense (FAF) tests and optical coherence tomography (OCT) scans to identify the condition.

Patients who were diagnosed with maculopathy had both longer durations of Elmiron use, averaging 20.3 years, and a cumulative dose of 1,650 grams. That compares to patients who did not have the condition who had only used Elmiron for an average of 6.3 years and had only 706.6 g of Elmiron exposure.

The scans of those with maculopathy showed characteristic punctate retinal pigment epithelium (RPE) macular lesions, speckled autofluorescense in the posterior pole with peripapillary extension and focal RPE thickening. In more severe cases, the OCT scans found RPE atrophy in the macula and the periphery.

“A prevalence of 20% in this study cohort suggests a significant risk of macular toxicity for PPS-treated patients,” the researchers concluded. “Characteristic alterations are best detected with FAF and NIR.”

Elmiron Retina Risks

To minimize the risks among Elmiron users, researchers recommend doctors obtain an initial baseline eye examination when the drug is prescribed, including FAF, NIR and OCT multimodal imaging.

The FAF and NIR imaging should be conducted annually for Elmiron patients, particularly when their cumulative dosages get close to 500 g. They warned that patients exposed to more than 1,500 g of Elmiron are at significant retinal toxicity risk.

The findings are similar to other studies, which have found multimodal imaging to be the best way to detect Elmiron eye damage early.

In addition, the rate of problems identified in this new research is similar to the findings of a study published in March by researchers from the University of Kentucky, who also found a 20% prevalence rate among long-term Elmiron users.

Elmiron Eye Damage Lawsuits

The findings are likely to play a large role in hundreds of product liability lawsuits now being pursued against the drug makers, alleging that users and the medical community were not adequately warned about the risk of eye damage from Elmiron, indicating that users could have avoided permanent vision loss if earlier information had been provided about the importance of monitoring and use of multimodal imaging.

Given common questions of fact and law raised in individual injury claims and Elmiron class action lawsuits pending throughout the federal court system, the litigation has been centralized in the U.S. District Court for the District of New Jersey, where one judge is presiding over coordinated discovery and pretrial proceedings.

As Elmiron lawyers continue to review and file claims in the coming months and years, it is ultimately expected that several thousands claims will eventually be included in the litigation.

In the coming years, it is expected that a small group of representative cases will be selected for early “bellwether” trials to help the parties gauge how juries will respond to the evidence and testimony that will be repeated throughout the claims.

While the outcome of these early bellwether trials will not be binding on other claims they will likely have a big influence on potential in Elmiron settlements the drug makers may pay to avoid the need for hundreds of individual cases to be remanded to U.S. District Courts nationwide for individual trials in future years.