On the same day that the U.S. Food and Drug Administration (FDA) approved the new Elmiron drug label warning regarding the risk of pigmentary maculopathy side effects, a new Elmiron lawsuit was filed in the U.S. District Court for the Eastern District of Pennsylvania, alleging macular degeneration and vision loss side effects from the interstitial cystitis drug. If you or someone you know has suffered pigmentary maculopathy, vision loss or any other eye disease allegedly linked to Elmiron, do not hesitate to contact an Elmiron injury lawyer to find out if you qualify for the litigation. You may be eligible for compensation for your alleged Elmiron side effect injuries, which you can pursue by filing a product liability lawsuit against Elmiron maker, Janssen Pharmaceuticals.
Elmiron, or pentosan polysulfate sodium, is a medication commonly prescribed to individuals with interstitial cystitis, a chronic, painful bladder condition that can be difficult to treat. In fact, Elmiron is the only approved drug treatment for interstitial cystitis, which affects between three and eight million women and between one and four million men in the United States. Elmiron first became available for consumer use in the U.S. in 1996 and Janssen Pharmaceuticals has marketed the drug for decades as a safe and effective treatment for interstitial cystitis. What Janssen failed to disclose though, is the possibility of long-term Elmiron users suffering irreversible vision loss and retinal damage. In fact, while vision specialists have for several years expressed growing concerns about vision loss side effects from Elmiron – concerns that prompted Health Canada and the European Medicines Agency to require updated Elmiron warnings last year – it was only earlier this month that Janssen finally updated the Elmiron drug label in the U.S. to include warnings about pigmentary maculopathy side effects.
Johnson & Johnson’s Janssen subsidiary faces a growing number of lawsuits alleging that the drug maker knew about the significant vision risks associated with Elmiron treatment, yet continued marketing the medication for years without adequate warnings for Elmiron users and the medical community. This new Elmiron injury lawsuit, filed by plaintiff Megan K. Mott, alleges that Janssen knew about the risk of vision problems with Elmiron, but withheld this information from the public in an effort to protect company profits. According to Mott’s complaint, she began taking Elmiron in 2005, at which point the drug label contained no warnings about the potential for Elmiron to cause irreversible damage to the retina. After taking the medication for years, Mott began to experience problems that left her with permanent vision loss. She was eventually diagnosed with Elmiron-associated macular degeneration in March 2020.
A series of case reports and scientific studies published over the past several years have highlighted cases where Elmiron users experienced visual symptoms ranging from difficulty adjusting to dim lighting, difficulty seeing close objects and blurred vision, to difficulty reading, dark spots in the vision, a loss of vision detail and other complications associated with a novel retinal disease known as pigmentary maculopathy. “Defendant ignored reports from patients and health care providers throughout the United States of Elmiron’s failure to perform as intended, and injuries associated with long term use which led to the severe and debilitating injuries suffered by Plaintiff, and numerous other patients,” Mott’s Elmiron lawsuit states. “Rather than doing adequate testing to determine the cause of these injuries or rule out Elmiron’s design as the cause of the injuries, Defendant continued to market Elmiron as a safe and effective prescription drug for interstitial cystitis.”
Mott’s complaint joins Elmiron lawsuits filed in courts across the country, each involving similar allegations that Janssen Pharmaceuticals failed to adequately warn Elmiron users about the potential for the interstitial cystitis medication to cause retinal damage, vision loss and pigmentary maculopathy. Unfortunately, because most ophthalmologists were previously unaware of the link between Elmiron and vision loss, many patients suffering from Elmiron-associated pigmentary maculopathy were misdiagnosed with age-related macular degeneration, pattern dystrophy and other unrelated eye diseases, and continued taking the interstitial cystitis drug for years. If you are currently taking or previously took Elmiron and you have been diagnosed with macular degeneration or pigmentary maculopathy, consult a knowledgeable Elmiron injury attorney as soon as possible to discuss your legal options.