Product liability lawsuits are being filed against the makers of Elmiron by consumers who claim that the prescription interstitial cystitis medication caused them to suffer retinal maculopathy and other eye diseases that may lead to permanent vision loss or blindness. A number of studies published over the last several years indicate that Elmiron, also known as pentosan polysulfate sodium or PPS, may be toxic to the retina, the thin layer of tissue at the back of the eye that senses light and allows us to see. As a result, patients taking Elmiron long-term for the treatment of interstitial cystitis may be at risk for irreversible retinal damage and/or vision loss.
Elmiron Treatment for Interstitial Cystitis
Elmiron (pentosan polysulfate sodium) is a medication widely prescribed for the treatment of interstitial cystitis (IC), a condition characterized by chronic pain in the bladder and pelvis area. IC belongs to a group of bladder conditions known collectively as painful bladder syndrome. More than one million Americans are estimated to suffer from symptoms of IC, mostly women. Unfortunately, there is no cure for interstitial cystitis and available treatment options are limited. In fact, Elmiron is the only oral medication that has been FDA-approved for the treatment of IC, which means individuals diagnosed with the chronic bladder condition are usually prescribed Elmiron and end up taking the drug for years.
Vision Loss Side Effects of Elmiron
Elmiron has been considered a mainstay of interstitial cystitis treatment dating back to the 1990s and it is likely that hundreds of thousands of people have been exposed to the drug since its inception. Unfortunately, prior to 2020, Janssen did not provide any warnings about the potential risk of retinal damage from long-term Elmiron use. Because of this, patients with interstitial cystitis who took Elmiron for years had no way of knowing that the drug may have been responsible for their vision-related issues. The following are some of the potentially permanent vision problems that Elmiron users may experience:
Slow adjustment to dim lighting
Dark spots in vision
Difficulty seeing close objects
Loss of vision detail
Loss of night vision
Maculopathy is the term used to describe a progressive eye disease affecting the macula, the part of the retina that allows us to read, recognize faces and colors, focus central vision, and see fine detail in objects. The unique type of maculopathy that has been linked to Elmiron treatment is known as pigmentary maculopathy and new research indicates that Elmiron-related pigmentary maculopathy may occur years after the drug treatment is discontinued.
Research Linking Retinal Changes to Elmiron Toxicity
A team of ophthalmologists from the Emory Eye Center in Atlanta, Georgia were the first to identify long-term use of Elmiron as a potential risk factor for permanent damage to the retina. In 2018, Dr. William Pearce and colleagues reported that six patients who were exposed to Elmiron for approximately 15 years had experienced unusual retinal changes. Following this initial report, a review of patients at Kaiser Permanente in Northern California in 2019 found that about 25% of patients with significant exposure to Elmiron showed definite signs of retinal damage. The ophthalmologists who conducted the review also found that this so-called Elmiron toxicity was often mistaken for other better-known eye diseases, such as pattern dystrophy or age-related macular degeneration.
In January 2020, those same ophthalmologists published a follow-up study of 117 patients with interstitial cystitis who took Elmiron. According to their findings, 27 of the patients showed signs of maculopathy. “We believe that our findings add strong support to the growing body of evidence that links long-term PPS use to the potential development of a toxic maculopathy,” the study authors wrote.
Janssen Adds Pigmentary Maculopathy Warning to Elmiron Label
Despite a growing body of research connecting long-term Elmiron use to potentially irreversible retinal damage, the FDA has yet to issue an Elmiron recall. However, faced with this mounting evidence of Elmiron toxicity, Janssen Pharmaceuticals did add a new warning to Elmiron’s prescribing information in June 2020, notifying consumers and healthcare providers about the possible risk of retinal pigmentary changes associated with long-term exposure to the IC drug. The new Elmiron warning reads as follows:
“Pigmentary changes in the retina, reported in the literature as pigmentary maculopathy, have been identified with long-term use of Elmiron. Although most of these cases occurred after 3 years of use or longer, cases have been seen with a shorter duration of use. While the etiology is unclear, cumulative dose appears to be a risk factor.”
Elmiron Lawsuits Alleging Maculopathy Side Effects
In the wake of the new Elmiron maculopathy warning, dozens of lawsuits have been brought against Janssen in state and federal courts nationwide, all of which involve similar allegations that the drug maker failed to disclose Elmiron vision loss risks to consumers and the medical community. Given the popularity of Elmiron as a treatment for interstitial cystitis and the debilitating nature of the alleged Elmiron-related injuries, the litigation is expected to grow significantly as current and former users continue to seek legal representation. Product liability lawyers are currently accepting cases from people who took Elmiron for two or more years and subsequently experienced vision problems like difficulty reading, slow adjustment to dim lighting, blurred vision, or vision loss.