Lawsuit Alleges Elmiron Causes Eye Damage, While No Better Than Placebo Treating Bladder Pain

A product liability lawsuit filed against Teva Pharmaceuticals, Johnson & Johnson and its Janssen subsidiary warns that the side effects of Elmiron not only increase the risk of eye damage and vision loss, but that the drug is also not effective at treating the underlying bladder pain for which it is prescribed.

The complaint (PDF) was filed by Hazel Boss late last month in the U.S. District Court for the District of New Jersey, indicating that she is one of the many users nationwide prescribed the interstitial cystitis drug who is now left with permanent retinal changes and vision problems, which could have been avoided if she never took Elmiron.

Johnson & Johnson and Janssen have marketed Elmiron (pentosan polysulfate sodium or PPS) as a safe and effective treatment for interstitial cystitis, which is commonly referred to as “bladder pain syndrome”. However, since there is no underlying cure for interstitial cystitis, many users are kept on the medication for years, and often decades.

Although independent studies and case reports published over the past decade have described cases of irreversible Elmiron retinal maculopathy, the first warnings about the risk of vision impairment and the importance of monitoring for retinal changes was not added to the FDA label warnings until last year. As a result, many doctors remained unaware of the connection between Elmiron and eye damage until recently, leading many users to continue taking the medication even after they developed signs or symptoms of vision side effects, further worsening the permanent damage to the retina.

Boss’s lawsuit indicates she was prescribed Elmiron from 2014 through 2020, after she was diagnosed with interstitial cystitis. As a result of the damage Elmiron caused to her eyes, Boss alleges she now suffers from difficulty adjusting to darkness, blurred vision, wavy vision and overall vision loss. She notes that medical studies have indicated further retinal and vision changes are likely to continue to progress even though she has ceased using the drug.

In addition to failing to warn about the potential side effects, Boss indicates that some studies have found Elmiron is no better than a placebo at preventing bladder pain, raising questions about how any level of eye damage risk could be justified.

Elmiron was approved based on two clinical trials that the lawsuit calls “seriously flawed”, noting they were not adequate or well controlled due to a lack of independence and the use of data the FDA had determined to be inadequate twice before its final approval.

“Prior to approval, one of the top concerns expressed by the FDA was that when the data from a single investigator was removed, there was no proof that Elmiron was an effective treatment (of) IC/Bladder Pain Syndrome,” the lawsuit states. “Since the initial approval, additional data has been published that serves as further evidence of Elmiron’s lack of efficacy.”

Hundreds of similar Elmiron eye damage lawsuits are being pursued throughout the federal court system by individuals previously diagnosed with age-related macular degeneration and other retina conditions, which are now recognized as Elmiron-associated maculopathy. Given common questions of fact and law, the cases have been centralized as part of a federal multidistrict litigation (MDL) in the District of New Jersey.

Following coordinated discovery, it is expected that a series of “bellwether” trials will likely be scheduled to help gauge how juries respond to certain evidence and testimony that is likely to be repeated throughout the litigation. However, unless the drug makers are able to negotiate Elmiron settlements or establish that they can consistently defend the safety of their drug at trial, hundreds of individual cases may later be remanded back to U.S. District Courts nationwide for individual jury trials nationwide in the coming years.