Elmiron Maculopathy Problems Found in 20% of Long-Term Users: Study

The findings of a new study highlights the serious risk of eye damage from Elmiron, indicating that one out of every five long-term users of the bladder drug may be left with retinal maculopathy, resulting in permanent and debilitating vision problems.

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 that they may be causing irreversible damage to their retina.

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.

Hundreds of former users are now pursuing lawsuits, alleging they may have avoided permanent Elmiron maculopathy problems if earlier information and warnings had been provided, and this new study may provide strong evidence to support these claims.

In findings published this month in the medical journal Current Opinion in Ophthalmology, researchers from the University of Kentucky indicate up to 20% of long-term users of the drug appear to have the specific type of maculopathy linked to Elmiron, which can lead to retinal changes and vision loss.

The researchers determined the average case of retinal pigment dysfunction appears to occur with exposure to 1-2 kg over a 10-15 year period. In addition, the retinal changes can continue to occur even after patients stop using the drug, the researchers warn.

Looking at data from cross-sectional studies, researchers indicate the findings appear to correlate cumulative dosing and the likelihood and severity of maculopathy from Elmiron. The researchers’ early estimates found a prevalence range of 12.7% to 41.7%, with an overall rate of about 20%.

“Reasonable evidence associates maculopathy with extended exposure to PPS, with an average reported incidence of around 20% in patients with long-term exposures,” the researchers concluded. “Patients with unexplained retinal pigment epithelium changes and difficulty with dark adaptation should be questioned regarding PPS exposure, and patients with known exposure to PPS should be examined. Further research is needed to refine screening protocols.”

The researchers advised health care professionals to consider baseline examinations and examinations at five years, or 500 g of exposure. After that, patients should undergo yearly screening, they concluded.

Elmiron Litigation

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.

While the parties are engaging in common and case-specific discovery, new studies continue to bolster the strength of the plaintiffs’ claims.

Last month, a study published in the medical journal Clinical Ophthalmology identified a distinct signature for Elmiron maculopathy which can be diagnosed through imaging exams.

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 maculopathy 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.