Lawsuit Claims Elmiron Drug Maker Knew About Pigmentary Maculopathy-Related Vision Problems

As new evidence comes to light about the potential for the interstitial cystitis drug Elmiron to cause permanent vision loss in users, the drug maker faces a growing number of lawsuits, the most recent of which alleges that Janssen Pharmaceuticals knew about the vision loss side effects of Elmiron and deliberately kept this information from the public. If you or a loved one took Elmiron and has since been diagnosed with pigmentary maculopathy, macular degeneration, Stargardt disease or another debilitating eye disease, you could be suffering from vision loss side effects of the widely used interstitial drug. Contact an experienced Elmiron vision loss attorney as soon as you can to discuss the possibility of filing an Elmiron lawsuit against Janssen Pharmaceuticals.

New Vision Loss Warnings Added to Elmiron Label

Just last month, the U.S. Food and Drug Administration (FDA) approved a new warning for the Elmiron drug label regarding the risk of retinal pigmentary changes and vision loss in users. “Pigmentary changes in the retina, reported in the literature as pigmentary maculopathy, have been identified with long-term use of ELMIRON® (see ADVERSE REACTIONS). Although most of these cases occurred after 3 years of use or longer, cases have been seen with a shorter duration of use,” the warning states. “While the etiology is unclear, cumulative dose appears to be a risk factor.” According to the new Elmiron warning label, visual symptoms reported by patients experiencing pigmentary changes in the retina potentially caused by Elmiron use include blurred vision, difficulty reading, and slow adjustment to low or reduced light environments.

These pigmentary maculopathy warnings came as a surprise to patients who had been taking Elmiron for years, unaware that the vision problems they were experiencing were associated with the drug they took for their bladder condition. Interstitial cystitis (IC) is a chronic condition characterized by bladder pain, bladder pressure and urinary urgency and the condition is part of a spectrum of diseases known as painful bladder syndrome. There is no cure for interstitial cystitis and the condition is often difficult to treat. In fact, Elmiron is the only approved oral treatment for interstitial cystitis, which is why many people diagnosed with IC have been taking Elmiron for years. The plaintiff in this latest Elmiron lawsuit reported taking the drug from about 1997 until 2004 and again from about 2016 until 2018. In April 2020, the plaintiff was diagnosed with macular degeneration, which she alleges was a direct side effect of her Elmiron treatment.

Link Between Elmiron and Vision Loss

Elmiron (pentosan polysulfate sodium or PPS) has been on the market in the United States since 1996, and during the past nearly 25 years, has been marketed by Janssen as a safe and effective treatment for interstitial cystitis. Even though concerns have existed for years about the risk of retina damage among Elmiron users, and despite the fact that Canada added warnings about Elmiron-associated maculopathy to the drug label in 2019, retinal maculopathy warnings were not added to the Elmiron drug label in the United States until June 2020. This latest Elmiron complaint, filed by plaintiff Audrey Howell in the U.S. District Court for the Northern District of Alabama on July 13, states, “It was only about two months prior to the date of the filing of this Complaint that Plaintiff first knew, or had any reason to know, that her vision-related injuries, including, but not limited to, macular degeneration could have been caused by Elmiron. Ms. Howell would not have used Elmiron had any or all of Defendants’ properly disclosed the risks associated with its use.”

Elmiron Lawsuits Over Vision Loss Side Effects

When the Elmiron label update finally came last month, it was supported by a series of studies and case reports published in recent years identifying cases where long-term Elmiron users suffered an unknown type of eye disease characterized by pigmentary changes in the retina. Among the numerous vision problems that have been linked to Elmiron treatment are vision loss, blurred vision, difficulty reading, problems adjusting to dim light and seeing close objects, vision distortion, dark spots, loss of vision detail and loss of night vision. Yet Elmiron users claim that Janssen deliberately withheld information about the risk of vision problems and blindness resulting from Elmiron-associated pigmentary maculopathy from the drug label for years. If you believe you have been adversely affected by vision loss side effects of Elmiron, consult a knowledgeable Elmiron injury lawyer today to discuss your legal options.