The makers of Elmiron, the only medication approved by the FDA to treat a painful bladder condition called interstitial cystitis, face close to 2,000 product liability lawsuits in state and federal courts across the country, all involving similar allegations that the drug caused users to suffer vision changes and put them at risk for blurred vision, difficulty reading, or even blindness. The number of Elmiron claims brought against Johnson & Johnson and its Janssen Pharmaceutical subsidiary is expected to continue to grow as the parties prepare for the first “bellwether” trials, scheduled to begin in March 2023. If you or someone you love has suffered pigmentary maculopathy or vision damage allegedly caused by Elmiron, contact Consumer Safety Watch right away to find out whether you may be eligible to file an Elmiron vision loss claim against the manufacturer.
Elmiron (pentosan polysulfate sodium) is a prescription medication commonly used to treat interstitial cystitis (IC), or painful bladder syndrome, a chronic and often debilitating condition characterized by bladder pain, bladder pressure, and sometimes pelvic pain. The exact cause of IC is unknown, but there is evidence that Elmiron may be beneficial in treating the pain and discomfort associated with IC. Unfortunately, because there is no cure for interstitial cystitis, patients prescribed Elmiron typically end up taking the drug for years, which research now shows could put them at risk for vision loss and other irreversible vision problems.
Since its approval in 1996, Elmiron has been marketed by Johnson & Johnson and Janssen Pharmaceuticals as safe and effective for the treatment of interstitial cystitis. However, many former Elmiron users now say that they have suffered a rare eye disorder known as pigmentary maculopathy, which can cause progressive vision loss, blurred or distorted vision, and poor vision in low-light conditions, among other debilitating vision problems. Studies and case reports published over the past several years have linked these vision problems to long-term treatment with Elmiron.
Researchers have identified this rare form of pigmentary maculopathy as a “novel and possibly avoidable maculopathy associated with chronic exposure to PPS (Elmiron).” This eye condition is caused by irreversible damage to the macula, or the central portion of the retina, which is responsible for our central vision, most of our color vision, and the fine detail we can see. The progressive, vision-threatening eye disorder was first pinpointed as a potential side effect of long-term Elmiron use in 2018, when researchers at the Emory Eye center in Atlanta, Georgia recognized chronic exposure to Elmiron as a common factor among patients who exhibited similar vision problems. In 2020, Janssen finally updated the Elmiron label to include a warning about pigmentary changes in the retina linked to long-term Elmiron treatment, noting that while “most of these cases occurred after 3 years of use or longer, cases have been seen with a shorter duration of use.”
Since concerns first emerged about the potential link between Elmiron and vision loss, more than a dozen studies, papers, and case reports have described the vision disorder that has been dubbed PPS (pentosan polysulfate sodium) maculopathy. This abundant research has triggered claims that Elmiron vision problems could have been avoided had the manufacturer provided accurate information about the potential risk of vision loss from Elmiron and the need for vision monitoring during treatment. However, because these side effects were never disclosed to patients or healthcare providers, many Elmiron users experiencing pigmentary maculopathy have been misdiagnosed with macular degeneration and other more common eye disorders, and have continued taking the IC drug. A growing number of Elmiron lawsuits now claim that Johnson & Johnson and Janssen Pharmaceuticals provided false and misleading information about the safety of Elmiron and seek to hold the drug makers accountable for the harm Elmiron users have suffered.
According to a case management order from November 1, 2022, there are at least 1,926 Elmiron lawsuits pending in state and federal courts nationwide, the majority of which have been consolidated in a multidistrict litigation (MDL) in New Jersey. If you took Elmiron to treat interstitial cystitis and you have suffered vision problems like blurred vision, vision distortion, difficulty reading, or difficulty adapting to dim lighting, you may have grounds to file an Elmiron lawsuit against Janssen Pharmaceuticas. Contact Consumer Safety Watch today to find out how we can help.